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1.
Plast Reconstr Surg Glob Open ; 12(3): e5665, 2024 Mar.
Article in English | MEDLINE | ID: mdl-38440365

ABSTRACT

Background: Studies comparing carpal tunnel release with ultrasound guidance (CTR-US) to mini-open CTR (mOCTR) are limited. This randomized trial compared the efficacy and safety of these techniques. Methods: In this multicenter randomized trial, patients were randomized (2:1) to unilateral CTR-US or mOCTR. Outcomes included Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ-SSS) and Functional Status Scale (BCTQ-FSS), numeric pain scale (0-10), EuroQoL-5 Dimension 5-Level (EQ-5D-5L), scar outcomes, and complications over 1 year. Results: Patients received CTR-US (n = 94) via wrist incision (mean 6 mm) or mOCTR (n = 28) via palmar incision (mean 22 mm). Comparing CTR-US with mOCTR, the mean changes in BCTQ-SSS (-1.8 versus -1.8; P = 0.96), BCTQ-FSS (-1.0 versus -1.0; P = 0.75), numeric pain scale (-3.9 versus -3.8; P = 0.74), and EQ-5D-5L (0.13 versus 0.12; P = 0.79) over 1 year were comparable between groups. Freedom from scar sensitivity or pain favored CTR-US (95% versus 74%; P = 0.005). Complications occurred in 2.1% versus 3.6% of patients (P = 0.55), all within 3 weeks postprocedure. There was one revision surgery in the CTR-US group, and no revisions for persistent or recurrent symptoms in either group. Conclusions: CTR-US and mOCTR demonstrated similar improvement in carpal tunnel syndrome symptoms and quality of life with comparable low complication rates over 1 year of follow-up. CTR-US was performed with a smaller incision and associated with less scar discomfort.

2.
J Hand Surg Am ; 2023 Jun 22.
Article in English | MEDLINE | ID: mdl-37354196

ABSTRACT

PURPOSE: The diagnosis of amyloidosis is important for early intervention, disease monitoring, and prevention of complications and progression. Carpal tunnel syndrome (CTS) and trigger digit (TD) are two common conditions associated with early disease. The purpose of this study was to define disease prevalence among patients with bilateral CTS and multiple TDs and assess for an increased rate of diagnosis in the presence of both. METHODS: Men older than 50 years and women older than 60 years of age diagnosed with bilateral CTS, multiple TDs, or a combination of the 2 were prospectively enrolled in our study. Tenosynovial biopsy samples taken at the time of surgery were tested for the presence of amyloid using Congo red staining. Demographic and medical covariates were also collected and analyzed for differences between amyloid-positive and -negative patients. RESULTS: Fifty-six patients were enrolled in the study, and nine patients tested positive for amyloid deposition. The demographics and medical comorbidities were similar between amyloid-positive and -negative patients. Thirty patients with bilateral CTS were enrolled, and four tested positive for amyloid. For patients with multiple TDs, a total of 17 patients were enrolled, and 4 tested positive for amyloid. Among patients with multiple TDs, only men tested positive for amyloid and were, on average, younger than those who tested negative (61 and 73 years, respectively). Patients presenting with a combination of CTS and TD did not exhibit increased amyloid discovery. CONCLUSIONS: Hand surgeons should consider tenosynovial biopsy in men older than 50 years and women older than 60 years presenting with either bilateral CTS or multiple TDs. TYPE OF STUDY/LEVEL OF EVIDENCE: Prognostic IV.

3.
Expert Rev Med Devices ; 20(7): 597-605, 2023 Jul.
Article in English | MEDLINE | ID: mdl-37254502

ABSTRACT

BACKGROUND: Comparative studies of carpal tunnel release with ultrasound guidance (CTR-US) vs. mini-open CTR (mOCTR) are limited, prompting development of this randomized trial to compare efficacy and safety of these techniques. RESEARCH DESIGN AND METHODS: Patients were randomized (2:1) to CTR-US or mOCTR, treated by experienced hand surgeons (median previous cases: 12 CTR-US; 1000 mOCTR), and followed for 3 months. RESULTS: Among 149 randomized patients, 122 received CTR-US (n = 94) or mOCTR (n = 28). Mean incision length was 6 ± 2 mm in the wrist (CTR-US) vs. 22 ± 7 mm in the palm (mOCTR) (p < 0.001). Median time to return to daily activities (2 vs. 2 days; p = 0.81) and work (3 vs. 4 days; p = 0.61) were similar. Both groups reported statistically significant and clinically important improvements in Boston Carpal Tunnel Questionnaire Symptom Severity and Functional Status Scales, Numeric Pain Scale, and EuroQoL-5 Dimension 5-Level, with no statistical differences between groups. Freedom from wound sensitivity and pain favored CTR-US (61.1% vs. 17.9%; p < 0.001). Adverse event rates were low in each group (2.1% vs. 3.6%; p = 0.55). CONCLUSIONS: The efficacy and safety of CTR-US were comparable to mOCTR despite less previous surgical experience with CTR-US. The choice of CTR technique should be determined by shared decision-making between patient and physician. CLINICAL TRIAL REGISTRATION: www.clinicaltrials.gov identifier is NCT05405218.


Subject(s)
Carpal Tunnel Syndrome , Humans , Treatment Outcome , Carpal Tunnel Syndrome/diagnostic imaging , Carpal Tunnel Syndrome/surgery , Hand , Ultrasonography , Pain
4.
Medicine (Baltimore) ; 101(41): e30775, 2022 Oct 14.
Article in English | MEDLINE | ID: mdl-36254038

ABSTRACT

BACKGROUND: Carpal tunnel release (CTR) is a surgical treatment option for patients with carpal tunnel syndrome (CTS) symptoms that are unresponsive to conservative treatment. Most patients experience symptomatic relief after CTR regardless of the surgical technique. However, direct comparisons of the safety and effectiveness between CTR surgical techniques are limited. The purpose of this randomized controlled trial is to compare the safety and effectiveness of CTR with ultrasound guidance (CTR-US) versus mini-open CTR (mOCTR) in subjects with symptomatic CTS. DESIGN AND METHODS: TUTOR (Trial of Ultrasound guided CTR versus Traditional Open Release) is a randomized controlled trial in which 120 subjects at up to 12 sites in the United States will be randomized (2:1) to receive CTR-US or mOCTR. The primary endpoint of the study is the percentage of patients who return to normal daily activities within 3 days of the procedure. Secondary endpoints of the study are median time to return to normal daily activities, percentage of patients who return to work within 3 days of the procedure, median time to return to work, Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ-SSS) change score at 3 months, BCTQ Functional Status Scale (BCTQ-FSS) change score at 3 months, Numeric Pain Scale change score at 3 months, EuroQoL-5 Dimension 5-Level (EQ-5D-5L) change score at 3 months, and the incidence of device- or procedure-related adverse events at 3 months. Patient follow-up in this trial will continue for 1 year. ETHICS AND DISSEMINATION: This study was approved by a central institutional review board and ongoing trial oversight will be provided by a data safety monitoring board (DSMB). The authors intend to report the results of this trial at medical conferences and peer-reviewed journals. The outcomes of TUTOR will have important clinical and economic implications for all stakeholders involved in treating patients with CTS. STUDY REGISTRATION: ClinicalTrials.gov (https://clinicaltrials.gov): NCT05405218. LEVEL OF EVIDENCE: 1.


Subject(s)
Carpal Tunnel Syndrome , Carpal Tunnel Syndrome/diagnostic imaging , Carpal Tunnel Syndrome/surgery , Humans , Surveys and Questionnaires , Ultrasonography , Ultrasonography, Interventional , Wrist
5.
J Shoulder Elbow Surg ; 30(5): 1128-1134, 2021 May.
Article in English | MEDLINE | ID: mdl-32858193

ABSTRACT

BACKGROUND: Limited data are available on the efficacy of cortisone injections for glenohumeral osteoarthritis (GHOA). The amount and longevity of pain relief provided by a single cortisone injection are unclear. Additionally, it remains uncertain how the severity of radiographic GHOA and patient-reported function and pain levels impact the efficacy of an injection. Therefore, we sought to describe the relief provided by a single, image-guided glenohumeral injection in patients with GHOA. We hypothesized that patients with more severe radiographic GHOA and poorer baseline shoulder function would require earlier secondary intervention. METHODS: Patients with symptomatic GHOA who elected to receive a corticosteroid injection for pain relief were prospectively enrolled. A phone interview was conducted to record the baseline Oxford Shoulder Score (OSS) and visual analog scale (VAS) score prior to the injection, as well as the OSS and VAS score at months 1, 2, 3, 4, 6, 9, and 12 after the injection. The endpoint of the study occurred when patients required a second injection, progressed to surgery, or reached month 12. Patients were grouped by their respective baseline OSS (mild vs. moderate or severe) and Samilson-Prieto radiographic classification (mild, moderate, or severe) for analysis. RESULTS: We analyzed 30 shoulders (29 patients). Of the patients, 52% were men. The average age was 66.1 years. No significant difference in overall survival (defined as no additional intervention) was seen between groups based on either the OSS or Samilson-Prieto grade. Additionally, the OSS and VAS score at each follow-up were compared with baseline values. For the entire cohort, a clinically significant difference was seen between baseline and months 1-4 for the OSS and between baseline and months 1-4, 6, 9, and 12 for the VAS score. DISCUSSION: This study aimed to determine the efficacy of corticosteroid injections for GHOA. There were no differences in the need for secondary intervention in this population based on the severity of either the OSS or the Samilson-Prieto radiographic classification. However, patients with more severe shoulder dysfunction based on the OSS did experience statistically significantly greater symptomatic relief than patients with milder dysfunction. Additionally, following a single injection, patients in this cohort experienced statistically and clinically relevant improvements in shoulder function and pain up to 4 months after injection.


Subject(s)
Osteoarthritis , Shoulder Joint , Adrenal Cortex Hormones/therapeutic use , Aged , Cohort Studies , Humans , Injections, Intra-Articular , Male , Osteoarthritis/diagnostic imaging , Osteoarthritis/drug therapy , Shoulder Joint/diagnostic imaging
6.
J Hand Surg Glob Online ; 3(5): 272-277, 2021 Sep.
Article in English | MEDLINE | ID: mdl-35415567

ABSTRACT

Purpose: Current prescribing information for the treatment of patients with Dupuytren contracture with injectable collagenase Clostridium histolyticum (CCH) recommends use of a night extension orthosis for 4 months after treatment. The present study examines whether this treatment improves the outcomes. Methods: Adult patients with Dupuytren contracture treated with CCH during the study period were eligible for inclusion. The patients were randomized to orthosis or no orthosis groups and were stratified based on the severity of contracture prior to randomization. The orthosis group was fitted postmanipulation with a hand-based custom orthosis that held the treated finger in maximal comfortable extension, and the patients were instructed to wear the orthosis at night for 3 months. The patients were assessed at 7-10 days, 30 days, and 90 days postmanipulation. Orthosis compliance was measured with a survey. The primary outcome measure was improvement in total active extension (TAE), defined as the sum of active metacarpophalangeal (MCP), proximal interphalangeal, and distal interphalangeal joint extension in the treated finger at 90 days after treatment. Secondary outcomes included total active flexion (TAF), Michigan Hand Questionnaire scores, patient satisfaction, and clinical success. Results: Twenty-six patients completed the study, 12 in the orthosis group and 14 in the no orthosis group. The majority of contractures (90%) were primarily through the MCP joint. The patients in both the groups demonstrated significant improvements in TAE at 90-day follow-up (orthosis P = .002, no orthosis P = .001) . The difference in improvement in the median TAE between the 2 groups was not significant (P = .40). There were no significant differences between groups for TAE, TAF, Michigan Hand Questionnaire scores, patient satisfaction, or clinical success at any of the time points assessed (P > .05). Conclusions: In patients with Dupuytren contracture with primarily MCP joint involvement, providing an orthosis after treatment with CCH may not offer a short-term benefit compared with CCH treatment alone in terms of TAE, TAF, or patient-reported outcome measures. Type of study/level of evidence: Therapeutic I.

7.
Hand (N Y) ; 15(3): 414-417, 2020 05.
Article in English | MEDLINE | ID: mdl-30141699

ABSTRACT

Background: The purpose of this study was to analyze the intrarater and interrater reliability of the Soong classification for volar locking plate placement on a randomly selected, consecutive series of radiographs. Our hypothesis was that the classification would be reliable. Methods: Six physicians of differing levels of training (orthopedic surgery intern to fellowship-trained upper extremity staff) were asked to review 40 radiographs in a random order on 2 separate occasions, 4 weeks apart. All observers graded each image (0, 1, or 2) based on the corresponding Soong grade. A weighted κ was used to determine the intrarater agreement. The interrater agreement was determined using an intraclass coefficient: Results: The intrarater reliability using a weighted κ ranged from 0.229 (95% confidence interval [CI]: 0.048-0.411) to 0.946 (95% CI: 0.840-1.051). The interrater intraclass coefficient for Randomization 1 was 0.944 (95% 0.912-0.967) and Randomization 2 was 0.877 (95% CI: 0.797-0.930). Conclusion: The Soong classification is a reliable tool, both interrater and intrarater, for assessing distal radius volar locking plate placement. The classification system remained reliable despite a randomly selected, consecutive series of images and physician observers of varying levels of training.


Subject(s)
Radius Fractures , Radius , Bone Plates , Fracture Fixation, Internal , Humans , Radius Fractures/diagnostic imaging , Radius Fractures/surgery , Reproducibility of Results
8.
J Hand Surg Am ; 44(10): 819-828.e17, 2019 Oct.
Article in English | MEDLINE | ID: mdl-31451320

ABSTRACT

PURPOSE: To investigate the variety of cases that are performed by newly graduated fellowship-trained orthopedic hand surgeons. METHODS: All cases submitted by board-eligible orthopedic surgeons taking part II of their board examination between 2004 and 2013 were obtained from the database of the American Board of Orthopaedic Surgery (ABOS). Each case was then categorized based on the fellowship training of the treating surgeon and whether it was a hand surgery case. Each hand surgery case was then further categorized into 1 of the 8 surgical categories used by the ABOS to determine eligibility for the Subspecialty Certificate in Orthopaedic Surgery of the Hand (SCOSH). RESULTS: During our study period, 6,854 orthopedic surgeons submitted 858,146 cases to the ABOS. Fellowship-trained hand surgeons made up 13% of all surgeons, and 24% of all submitted cases were hand surgery cases. Based on the cases submitted, 44% of hand surgeons were not on track to become eligible for the SCOSH. The most common reason for not reaching eligibility was failure to meet the minimum requirements in 1 of either the congenital, the skin and wound problems, the contracture and joint stiffness, the microvascular, or the tumor categories. CONCLUSIONS: A large proportion of fellowship-trained orthopedic hand surgeons are not on track to meet the minimum eligibility requirements for the ABOS SCOSH during their part II case collections. Their case profile is not sufficiently diverse to be considered an active hand surgery practice for the purpose of SCOSH eligibility. CLINICAL RELEVANCE: This study highlights 1 possible reason why over one-third of young hand surgeons do not obtain their subspecialty certification.


Subject(s)
Certification , Orthopedic Procedures/statistics & numerical data , Orthopedic Surgeons , Practice Patterns, Physicians'/statistics & numerical data , Specialty Boards , Databases, Factual , Fellowships and Scholarships , Humans , United States
9.
Bull Hosp Jt Dis (2013) ; 76(3): 183-191, 2018 Sep.
Article in English | MEDLINE | ID: mdl-31513522

ABSTRACT

PURPOSE: To examine current practice patterns in occupational radiation safety by members of the American Society for Surgery of the Hand (ASSH) and to assess if these vary by surgeon demographics and experience. METHODS: An online survey was sent to members of the ASSH and included 18 questions on fluoroscopy practice patterns as well as demographic information, including gender, years of experience, specialty, and geographic region. Multivariate logistic and multinomial regressions were used to determine predictors for fluoroscopy practice patterns while adjusting for these demographic factors. RESULTS: 904 surgeons (27%) responded to the study. The majority of surgeons preferred the mini C-arm for hand (91%) and elbow (70%) surgeries. Most did not use a personal dosimeter (70%). Forty-two percent of surgeons while using the mini C-arm did not use protective devices while only 5% of surgeons did not while using the standard C-arm. Women, surgeons with less than 10 years of experience, and responders in the western United States were the most likely to use protective devices. CONCLUSIONS: Most surveyed surgeons do not monitor their radiation exposure, but the majority of surgeons utilize protective devices. We have identified groups that are most and least likely to comply with recommendations for proper radiation safety.


Subject(s)
Fluoroscopy , Hand/surgery , Practice Patterns, Physicians' , Radiation Exposure/prevention & control , Radiation Monitoring , Radiation Protection , Female , Humans , Male , Monitoring, Intraoperative , Radiation Dosage , Surveys and Questionnaires , United States
10.
J Hand Surg Am ; 42(3): 210-212, 2017 Mar.
Article in English | MEDLINE | ID: mdl-28259277

ABSTRACT

Adding a librarian to an upper extremity surgical and therapy practice has many advantages (educational, research, remaining on the cutting edge of technology). As an embedded team member, the librarian at the Indiana Hand to Shoulder Center prepares literature reviews, creates Google Scholar Alerts for individual clinicians, and introduces developing technologies such as 3-dimensional printers, Smartphone Apps, and online access to nontraditional resources. With the librarian relieving clinicians of these responsibilities, surgeons can devote more time to clinical and research activities. Private practices unable to support their own librarian could share access to a librarian via Skype, Face Time, and video conferencing. Another small practice alternative is contracting services from a local medical school library that designates a librarian as its liaison.


Subject(s)
Academic Medical Centers/organization & administration , Biomedical Research/organization & administration , Librarians , Patient Care Team/organization & administration , Surgical Procedures, Operative/education , Upper Extremity/surgery , Academic Medical Centers/standards , Biomedical Research/standards , Fellowships and Scholarships/standards , Humans , Patient Care Team/standards , Surgical Procedures, Operative/standards
11.
J Hand Surg Am ; 42(5): 391.e1-391.e8, 2017 May.
Article in English | MEDLINE | ID: mdl-28341067

ABSTRACT

PURPOSE: Collagenase Clostridium histolyticum (CCH) is approved for the treatment of adults with Dupuytren contracture with a palpable cord. This open-label, phase 4 study evaluated the safety and efficacy of CCH for the retreatment of recurrent contractures in joints that were previously effectively treated with CCH. METHODS: Patients participating in a long-term follow-up study who had contracture recurrence (increased ≥ 20° with a palpable cord) after successful treatment in the previous study were eligible. Recurrent joint contractures were treated with up to 3 CCH injections (∼ 1 month apart). Patients were followed for 1 year to evaluate safety. Assessments included change in joint contracture, range of motion, and the percentage of joints that achieved contracture of 5° or less at day 30 after the last injection. RESULTS: The efficacy analysis included 51 patients with 1 treated joint per patient (31 metacarpophalangeal, 20 proximal interphalangeal). A total of 35 joints (69%) received 1 injection, 12 (24%) received 2 injections, and 4 (8%) received 3 injections. Fifty-seven percent of joints achieved contracture of 5° or less (29 of 51). Overall, 86% (43 of 50) patients had a 20° or greater increase in range of motion. The adverse event profile was consistent with previous studies. One ligament injury was reported. CONCLUSIONS: At a short-term follow-up of 1 year, recurrent contracture in joints previously successfully treated with CCH may be effectively retreated with up to 3 injections of CCH. TYPE OF STUDY/LEVEL OF EVIDENCE: Therapeutic IV.


Subject(s)
Dupuytren Contracture/drug therapy , Microbial Collagenase/therapeutic use , Aged , Female , Follow-Up Studies , Humans , Male , Middle Aged , Range of Motion, Articular , Recurrence , Retreatment , Treatment Outcome
12.
Hand (N Y) ; 10(3): 578-82, 2015 Sep.
Article in English | MEDLINE | ID: mdl-26330801

ABSTRACT

BACKGROUND: Collagenase clostridium histolyticum (CCH) injection for Dupuytren contracture was approved in the USA in 2010. Current FDA guidelines stipulate that finger manipulation occurs the day following injection. To investigate the safety and efficacy of delaying manipulation to 2 or 4 days following CCH injection, we conducted a prospective, randomized trial at two sites. METHODS: Patients with Dupuytren contracture involving the metacarpophalangeal (MCP) joint ≥20° caused by a palpable cord participated. All patients received one dose of CCH (0.58 mg/0.25 ml) and were followed for 90 days. The primary end point was the percent of patients maintaining clinical success (reduction of contracture to 0°-5°) at 90 days post-injection. Adverse events and change in Michigan Hand Questionnaire (MHQ) score were recorded as secondary end points. RESULTS: Thirty-seven patients enrolled; 13 were manipulated on day 1, 11 on day 2, and 13 on day 4. At 30 days after injection, the percentage of patients obtaining reduction of contracture to <0°-5° extension was 92, 82, and 85 % in groups 1, 2, and 3, respectively, with no significant difference. At 90 days follow-up, the percentage of patients maintaining 0°-5° extension was 91, 82, and 83 % in groups 1, 2, and 3, respectively, with no significant difference. Adverse events were comparable to rates in prior studies. There were no serious adverse events. There was no statistical difference in MHQ scores between groups at any time point. CONCLUSIONS: Delaying manipulation to day 2 or 4 following CCH injection for MCP joint contractures does not increase adverse events or result in loss of efficacy. LEVEL OF EVIDENCE: Therapeutic, Level II.

13.
J Hand Surg Am ; 40(8): 1597-605, 2015 Aug.
Article in English | MEDLINE | ID: mdl-26096221

ABSTRACT

PURPOSE: Collagenase Option for Reduction of Dupuytren Long-Term Evaluation of Safety Study was a 5-year noninterventional follow-up study to determine long-term efficacy and safety of collagenase clostridium histolyticum (CCH) treatment for Dupuytren contracture. METHODS: Patients from previous CCH clinical studies were eligible. Enrolled patients were evaluated annually for contracture and safety at 2, 3, 4, and 5 years after their first injection (0.58 mg) of CCH. In successfully treated joints (≤ 5° contracture following CCH treatment), recurrence was defined as 20° or greater worsening (relative to day 30 after the last injection) with a palpable cord or any medical/surgical intervention to correct new/worsening contracture. A post hoc analysis was also conducted using a less stringent threshold (≥ 30° worsening) for comparison with criteria historically used to assess surgical treatment. RESULTS: Of 950 eligible patients, 644 enrolled (1,081 treated joints). At year 5, 47% (291 of 623) of successfully treated joints had recurrence (≥ 20° worsening)-39% (178 of 451) of metacarpophalangeal and 66% (113 of 172) of proximal interphalangeal joints. At year 5, 32% (198 of 623) of successfully treated joints had 30° or greater worsening (metacarpophalangeal 26% [119 of 451] and proximal interphalangeal 46% [79 of 172] joints). Of 105 secondary interventions performed in the successfully treated joints, 47% (49 of 105) received fasciectomy, 30% (32 of 105) received additional CCH, and 23% (24 of 105) received other interventions. One mild adverse event was attributed to CCH treatment (skin atrophy [decreased ring finger circumference from thinning of Dupuytren tissue]). Antibodies to clostridial type I and/or II collagenase were found in 93% of patients, but over the 5 years of follow-up, this did not correspond to any reported clinical adverse events. CONCLUSIONS: Five years after successful CCH treatment, the overall recurrence rate of 47% was comparable with published recurrence rates after surgical treatments, with one reported long-term treatment-related adverse event. Collagenase clostridium histolyticum injection proved to be an effective and safe treatment for Dupuytren contracture. For those receiving treatment during follow-up, both CCH and fasciectomy were elected options. TYPE OF STUDY/LEVEL OF EVIDENCE: Therapeutic II.


Subject(s)
Clostridium histolyticum , Dupuytren Contracture/therapy , Microbial Collagenase/therapeutic use , Aged , Female , Follow-Up Studies , Humans , Male , Middle Aged , Recurrence , Time Factors , Treatment Outcome
14.
J Hand Surg Am ; 39(1): 57-64, 2014 Jan.
Article in English | MEDLINE | ID: mdl-24315486

ABSTRACT

PURPOSE: To assess the safety and efficacy of 2 concurrent injections of collagenase clostridium histolyticum (CCH) in the same hand to treat multiple Dupuytren flexion contractures. METHODS: In a multicenter, open-label phase IIIb study, 60 patients received two 0.58-mg CCH doses injected into cords affecting 2 joints in the same hand during 1 visit, followed by finger extension approximately 24 hours later. Efficacy at postinjection day 30 (change in flexion contracture and active range of motion, patient satisfaction, physician-rated improvement, and rates of clinical success [flexion contracture 5° or less]) and adverse events were summarized. RESULTS: The concurrent injections were most commonly administered in cords affecting metacarpophalangeal (MCP) and proximal interphalangeal (PIP) joints on the same finger (47%) or 2 MCP joints on different fingers of the same hand (37%). Mean total (sum of the 2 treated joints) flexion contracture decreased 76%, from 87° to 24° (MCP joints: 86%; PIP joints: 66%). Mean total range of motion increased from 100° to 161°. Clinical success was 76% for MCP joints and 33% for PIP joints. Most patients were very satisfied (60%) or quite satisfied (28%) with treatment. Most investigators rated treated joints as very much improved (55%) or much improved (37%). The most common treatment-related adverse events (> 75% of patients) were contusion, pain in extremity, and edema peripheral (local edema). Most adverse events were mild to moderate in severity. Serious complications included 1 pulley rupture related to study medication and 1 flexor tendon rupture (following conclusion of the study). There were no systemic complications. CONCLUSIONS: Results suggest that 2 affected joints can be effectively and safely treated with concurrent CCH injections. There was an increased incidence of some adverse events with concurrent treatment (pruritus, lymphadenopathy, blood blister, and skin laceration) compared with treatment of a single joint. High degrees of patient satisfaction and physician-rated improvement were reported. TYPE OF STUDY/LEVEL OF EVIDENCE: Therapeutic IV.


Subject(s)
Dupuytren Contracture/drug therapy , Microbial Collagenase/administration & dosage , Aged , Dupuytren Contracture/physiopathology , Female , Finger Joint/drug effects , Finger Joint/physiopathology , Humans , Injections, Intralesional , Male , Metacarpophalangeal Joint/drug effects , Metacarpophalangeal Joint/physiopathology , Microbial Collagenase/adverse effects , Middle Aged , Range of Motion, Articular/drug effects , Range of Motion, Articular/physiology , Retreatment
15.
J Hand Surg Am ; 38(1): 12-22, 2013 Jan.
Article in English | MEDLINE | ID: mdl-23200951

ABSTRACT

PURPOSE: To evaluate long-term efficacy and safety of collagenase clostridium histolyticum (CCH) after the third year of a 5-year nontreatment follow-up study, Collagenase Option for Reduction of Dupuytren Long-Term Evaluation of Safety Study. METHODS: This study enrolled Dupuytren contracture patients from 5 previous clinical studies. Beginning 2 years after their first CCH injection, we re-evaluated patients annually for joint contracture and safety. Recurrence in a previously successfully treated joint (success = 0° to 5° contracture after CCH administration) was defined as 20° or greater worsening in contracture in the presence of a palpable cord or medical/surgical intervention to correct new or worsening contracture. We assessed partially corrected joints (joints reduced 20° or more from baseline contracture but not to 0° to 5°) for nondurable response, also defined as 20° or greater worsening of contracture or medical/surgical intervention. RESULTS: Of 1,080 CCH-treated joints (648 metacarpophalangeal [MCP]; 432 proximal interphalangeal [PIP]; n = 643 patients), 623 (451 MCP, 172 PIP) had achieved 0° to 5° contracture in the original study. Of these joints, 35% (217 of 623) recurred (MCP 27%; PIP 56%). Of these recurrences, an intervention was performed in 7%. Of the 1,080 CCH-treated joints, 301 were partially corrected in the original study. Of these, 50% (150 of 301; MCP: 38% [57 of 152]; PIP: 62% [93 of 149]) had nondurable response. We identified no new long-term or serious adverse events attributed to CCH during follow-up. Anti-clostridial type I collagenase and/or anti-clostridial type II collagenase antibodies were reported for 96% or more of patients who received 2 or more CCH injections and 82% who received 1 injection. CONCLUSIONS: The recurrence rate, which is comparable to other standard treatments, and the absence of long-term adverse events 3 years after initial treatment indicate that CCH is an effective and safe treatment for Dupuytren contracture. Most successfully treated joints had a contracture well below the threshold for surgical intervention 3 years after treatment. Recurrence rates among successfully treated joints were lower than nondurable response rates among partially corrected joints. TYPE OF STUDY/LEVEL OF EVIDENCE: Therapeutic IV.


Subject(s)
Clostridium histolyticum/enzymology , Dupuytren Contracture/drug therapy , Microbial Collagenase/administration & dosage , Aged , Female , Follow-Up Studies , Humans , Injections, Intralesional , Male , Middle Aged , Recurrence , Treatment Outcome
17.
J Hand Surg Am ; 37(11): 2408-11, 2012 Nov.
Article in English | MEDLINE | ID: mdl-22995697
18.
Hand Clin ; 26(2): 191-204, 2010 May.
Article in English | MEDLINE | ID: mdl-20494745

ABSTRACT

The stiff finger is a frequently encountered entity in hand surgical practice. It stems from a myriad of causes, may have multiple components, and requires a variety of solutions. A true understanding of the ideal treatments for the stiff finger requires a basic understanding of the local milieu that arises from injury and the anatomic features that are at risk for pathologic changes. Hand surgeons must be able to help patients understand the various factors at play and the time course of wound healing and injury-induced inflammation, because an educated and motivated patient is the best ally in the battle against the stiff finger.


Subject(s)
Contracture/physiopathology , Finger Injuries/physiopathology , Finger Joint/physiopathology , Metacarpophalangeal Joint/physiopathology , Tissue Adhesions/physiopathology , Contracture/therapy , Humans , Movement/physiology , Orthopedic Procedures , Patient Education as Topic , Physical Therapy Modalities , Postoperative Care , Splints , Suture Techniques , Tendons/surgery , Tissue Adhesions/therapy , Wound Healing/physiology
19.
N Engl J Med ; 361(10): 968-79, 2009 Sep 03.
Article in English | MEDLINE | ID: mdl-19726771

ABSTRACT

BACKGROUND: Dupuytren's disease limits hand function, diminishes the quality of life, and may ultimately disable the hand. Surgery followed by hand therapy is standard treatment, but it is associated with serious potential complications. Injection of collagenase clostridium histolyticum, an office-based, nonsurgical option, may reduce joint contractures caused by Dupuytren's disease. METHODS: We enrolled 308 patients with joint contractures of 20 degrees or more in this prospective, randomized, double-blind, placebo-controlled, multicenter trial. The primary metacarpophalangeal or proximal interphalangeal joints of these patients were randomly assigned to receive up to three injections of collagenase clostridium histolyticum (at a dose of 0.58 mg per injection) or placebo in the contracted collagen cord at 30-day intervals. One day after injection, the joints were manipulated. The primary end point was a reduction in contracture to 0 to 5 degrees of full extension 30 days after the last injection. Twenty-six secondary end points were evaluated, and data on adverse events were collected. RESULTS: Collagenase treatment significantly improved outcomes. More cords that were injected with collagenase than cords injected with placebo met the primary end point (64.0% vs. 6.8%, P < 0.001), as well as all secondary end points (P < or = 0.002). Overall, the range of motion in the joints was significantly improved after injection with collagenase as compared with placebo (from 43.9 to 80.7 degrees vs. from 45.3 to 49.5 degrees, P < 0.001). The most commonly reported adverse events were localized swelling, pain, bruising, pruritus, and transient regional lymph-node enlargement and tenderness. Three treatment-related serious adverse events were reported: two tendon ruptures and one case of complex regional pain syndrome. No significant changes in flexion or grip strength, no systemic allergic reactions, and no nerve injuries were observed. CONCLUSIONS: Collagenase clostridium histolyticum significantly reduced contractures and improved the range of motion in joints affected by advanced Dupuytren's disease. (ClinicalTrials.gov number, NCT00528606.)


Subject(s)
Clostridium histolyticum/enzymology , Dupuytren Contracture/drug therapy , Microbial Collagenase/therapeutic use , Double-Blind Method , Dupuytren Contracture/physiopathology , Female , Humans , Injections, Intralesional , Male , Microbial Collagenase/adverse effects , Middle Aged , Range of Motion, Articular , Tendon Injuries/etiology , Treatment Outcome
20.
J Hand Surg Am ; 33(10): 1878-81, 2008 Dec.
Article in English | MEDLINE | ID: mdl-19084194

ABSTRACT

This case report describes an anomalous muscle, the flexor carpi radialis brevis (FCRB), that presented as a painful, enlarging volar forearm mass. After magnetic resonance imaging (MRI) characterization, surgical exploration confirmed that the FCRB tendon crossed over the flexor carpi radialis (FCR) tendon and the resultant tenosynovitis was the apparent cause of the patient's symptoms.


Subject(s)
Muscle, Skeletal/abnormalities , Tenosynovitis/diagnosis , Tenosynovitis/etiology , Forearm , Humans , Male , Middle Aged , Tenosynovitis/surgery
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