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1.
Sports Health ; 9(6): 555-563, 2017.
Article in English | MEDLINE | ID: mdl-28719761

ABSTRACT

CONTEXT: We present the current spectrum of postoperative management practices for patients receiving distal femur osteochondral allograft (OCA) transplants. EVIDENCE ACQUISITION: The Joint Restoration Foundation database was examined in cooperation with the Metrics of Osteochondral Allografts study group to identify 121 surgeons who had performed at least 1 OCA transplant in the past year; 63% of surgeons responded. STUDY DESIGN: Clinical survey. LEVEL OF EVIDENCE: Level 3. RESULTS: Postoperative weightbearing restrictions ranged from immediate nonweightbearing with full weightbearing by 12 weeks to immediate weightbearing as tolerated. Most surgeons who performed fewer (<10) OCA transplants per year followed the most restrictive protocol, while surgeons who performed more (>20) OCA transplants per year followed the least restrictive protocol. One-third of surgeons with the most restrictive protocol were more likely to change their protocol to be less restrictive over time, while none of those with the least restrictive protocol changed their protocol over time. Fifty-five percent of surgeons permitted return to full activity at 26 weeks, while 27% of surgeons lifted restrictions at 16 weeks. CONCLUSION: Characterization of the spectrum of postoperative management practices after OCA transplantation provides a foundation for future investigations regarding patient outcomes and associated cost to establish best practice guidelines. Fundamentally, surgeons with more experience with this procedure tended to be more aggressive with their postoperative rehabilitation guidelines. Most commonly, rehabilitation provided for some degree of limited weightbearing; however, the spectrum also included immediate full weightbearing practices.


Subject(s)
Arthroplasty, Replacement, Knee/methods , Arthroplasty, Replacement, Knee/rehabilitation , Bone Transplantation , Cartilage/transplantation , Orthopedic Surgeons , Practice Patterns, Physicians' , Clinical Competence , Femur/surgery , Humans , Postoperative Care , Time Factors , Transplantation, Homologous , Weight-Bearing
2.
Am J Sports Med ; 45(4): 875-883, 2017 Mar.
Article in English | MEDLINE | ID: mdl-28068480

ABSTRACT

BACKGROUND: Autologous cartilage tissue implants, including the NeoCart implant, are intended to repair focal articular cartilage lesions. Short-term results from United States Food and Drug Administration (FDA) phase I and phase II clinical trials indicated that the NeoCart implant was safe when surgically applied as a cell-based therapy and efficacious compared with microfracture. HYPOTHESIS: Quantitative magnetic resonance imaging (MRI) analysis would reveal NeoCart tissue maturation through to 60-month follow-up. STUDY DESIGN: Case series; Level of evidence, 4. METHODS: Patients with symptomatic full-thickness cartilage lesions of the distal femoral condyle were treated with NeoCart in FDA clinical trials. Safety and efficacy were evaluated prospectively by MRI and clinical patient-reported outcomes (PROs) through to 60-month follow-up. Qualitative MRI metrics were quantified according to modified MOCART (magnetic resonance observation of cartilage repair tissue) criteria, with an independent evaluation of repair tissue signal intensity. Subjective PROs and objective range of motion (ROM) were obtained at baseline and through to 60 months. RESULTS: Twenty-nine patients treated with NeoCart were observed over a mean of 52.0 ± 15.5 months (median, 60 months). MOCART analyses indicated significant improvement ( P < .001) in cartilage quality from 3 to 24 months, with stabilization from 24 to 60 months. Signal intensity of the repair tissue evolved from hyperintense at early follow-up to isointense after 6 months and to hypointense after 24 months. The temporal progression toward hypointense T2 signals at later time points observed here indicated a further reorganization of the repair tissue toward a dense tissue that was less similar to the surrounding native tissue. However, 80% of patients showed evidence of subchondral bone changes on MRI at all time points; 4 patients (14%) showed no improvement of MRI criteria. Compared with baseline values, significant improvement ( P < .001) was seen in PROs (mean [±SD] baseline to mean [±SD] final follow-up), including the International Knee Documentation Committee score (47.9 ± 17.4 to 75.5 ± 22.1), physical component summary of the Short Form-36 (40.5 ± 7.2 to 51.4 ± 8.1), and all 5 domains of the Knee injury and Osteoarthritis Outcome Score (Pain: 64.8 ± 12.1 to 86.1 ± 17.3; Activities of Daily Living: 75.5 ± 14.8 to 91.6 ± 13.8; Quality of Life: 28.6 ± 15.5 to 69.4 ± 28.0; Symptoms: 65.8 ± 13.8 to 86.6 ± 13.4; Sports and Recreation: 41.4 ± 24.3 to 72.4 ± 28.8). Significant ( P < .0001) decreases from baseline scores for the visual analog scale for pain (34.6 ± 22.5) were seen by 6 months and sustained at final follow-up (14.3 ± 18.4). ROM significantly ( P < .0001) improved from baseline (131.5° ± 7.9°) to final follow-up (140.7° ± 6.3°). CONCLUSION: Longitudinal MRI analysis demonstrated that NeoCart-based repair tissue is durable and evolves over time. For a majority of patients, this progression trended from an initial hyperintense signal to a hypointense signal at later follow-ups. Changes in radiographic measures over time corresponded with improvement in clinical measures, with maximum benefits experienced at 24-month follow-up. Similarly, clinical efficacy for the total cohort, determined by clinical outcome scores, reached a maximum at 24 months without decline to 60 months. Results from safety and exploratory clinical trials indicate that NeoCart is a safe and effective treatment for articular cartilage lesions through to 5-year follow-up. Registration: NCT00548119 ( ClinicalTrials.gov identifier).


Subject(s)
Cartilage, Articular/injuries , Cartilage/transplantation , Knee Injuries/diagnostic imaging , Knee Injuries/surgery , Magnetic Resonance Imaging , Activities of Daily Living , Adult , Cartilage, Articular/diagnostic imaging , Female , Follow-Up Studies , Humans , Male , Middle Aged , Pain Measurement , Prospective Studies , Quality of Life , Range of Motion, Articular , Transplantation, Autologous , Treatment Outcome , Visual Analog Scale , Wound Healing , Young Adult
3.
Spine (Phila Pa 1976) ; 42(15): 1151-1157, 2017 Aug 01.
Article in English | MEDLINE | ID: mdl-27902557

ABSTRACT

STUDY DESIGN: Prospective, multicenter. OBJECTIVE: To determine if stiffness significantly affects function or satisfaction after pan-lumbar arthrodesis. SUMMARY OF BACKGROUND DATA: The Lumbar Stiffness Disability Index (LSDI) is a validated measure of the effect of lumbar stiffness on functional activities. Data suggests that patients undergoing fusion of the entire lumbar spine are at greatest risk of functional limitations from stiffness. METHODS: The LSDI, Short Form 36, Scoliosis Research Society-22, and Oswestry Disability Index were administered preoperatively and at 2-year minimum follow-up to 103 spinal deformity patients from 11 centers. Patients were separated according to the proximal arthrodesis level; upper thoracic (T2-5) to pelvis (UT-Pelvis) or thoraco-lumbar (T10-T12) to pelvis (TL-Pelvis). Outcome scores were compared using Student t test or Tukey-Kramer Honest Significant Difference Analysis of Variance. Regression analysis of final LSDI scores versus Scoliosis Research Society-22 Satisfaction scores was performed. RESULTS: Mean ages, baseline values, and final scores of all outcome parameters were statistically equivalent in the two groups. Final LSDI scores did not change significantly from baseline in the UT-Pelvis (P = 0.478) or TL-Pelvis (P = 0.301) groups. In contrast, highly significant improvements (P ≤ 0.0001) from baseline were seen in both groups for other health-related QoL measures. The 2-year Satisfaction scores were statistically equivalent in the two groups, and the correlation between final LSDI and Satisfaction scores in the entire cohort was not significant (R = 0.013, P = 0.146). CONCLUSION: Patients undergoing pan-lumbar arthrodesis for adult spinal deformity did not experience substantial increases in disability due to stiffness of the low back, although they did report significant improvements in other health-related QoL measures. Further, LSDI scores did not correlate with patient satisfaction. There were no significant differences in perceived stiffness effects whether arthrodesis stopped in the thoracolumbar or upper thoracic regions. We hope these results will be useful to spine surgeons and patients during preoperative planning and discussions. LEVEL OF EVIDENCE: 2.


Subject(s)
Endpoint Determination/trends , Lumbar Vertebrae/surgery , Patient Satisfaction , Range of Motion, Articular/physiology , Spinal Diseases/surgery , Spinal Fusion/trends , Adult , Aged , Aged, 80 and over , Arthrodesis/adverse effects , Arthrodesis/trends , Female , Follow-Up Studies , Humans , Lumbar Vertebrae/diagnostic imaging , Male , Middle Aged , Prospective Studies , Recovery of Function/physiology , Spinal Diseases/diagnostic imaging , Spinal Fusion/adverse effects , Treatment Outcome
4.
Spine (Phila Pa 1976) ; 39(24): E1468-74, 2014 Nov 15.
Article in English | MEDLINE | ID: mdl-25202930

ABSTRACT

STUDY DESIGN: Prospective cohort study. OBJECTIVE: To understand whether patients actually perceive increased limitations as compared with their preoperative state due to stiffness after lumbar arthrodesis. SUMMARY OF BACKGROUND DATA: Lumbar arthrodesis by intention eliminates spinal motion in an attempt to decrease pain, deformity, and instability. Independent of pain, loss of mobility can impact ability to perform certain activities of daily living. The lumbar stiffness disability index (LSDI) is a validated measure of the effect of lumbar stiffness on functional activities. To date, no prospective evaluations of stiffness impacts on patient function after lumbar arthrodesis have been reported. METHODS: The LSDI, 36-Item Short Form Health Survey, and Oswestry Disability Index were administered preoperatively and at 2-year minimum follow-up to 62 adult patients undergoing lumbar fusion for degenerative disease or spinal deformity. Patients also completed a satisfaction questionnaire at 2 years. Patients were separated according to the number of lumbar arthrodesis levels. Pre- and postoperative LSDI, 36-Item Short Form Health Survey physical composite score, and Oswestry Disability Index scores were compared using paired t tests. RESULTS: Significant improvements in Oswestry Disability Index were observed across all arthrodesis levels, and significant improvements in physical composite score were observed at level 1 and at 5 or more levels. Patients undergoing 1-level arthrodesis demonstrated statistically significant decreases in LSDI scores, indicating less impact from stiffness than at baseline. Patients with 3 or 4 levels and 5 or more levels of arthrodesis showed increases in LSDI scores, although none reached significance with the numbers available. Forty-six percent of patients reported that low back stiffness created significant limitations in activities of daily living, although 97% indicated that they would undergo the same procedure again and 91% reported that any increase in stiffness was an acceptable trade-off for their functional improvements from lumbar arthrodesis. CONCLUSION: Patients undergoing elective lumbar arthrodesis reported relatively limited functional deficit due to stiffness at 2-year follow-up. Paradoxically, patients undergoing 1-level arthrodesis actually reported significantly less limitation due to stiffness postoperatively. Although the effects of stiffness did trend toward greater impacts among patients undergoing longer fusions, 91% of patients were satisfied with trade-offs of function and pain relief in exchange for perceived increases in lumbar stiffness.


Subject(s)
Internal Fixators/adverse effects , Lumbar Vertebrae/physiopathology , Lumbar Vertebrae/surgery , Movement/physiology , Spinal Fusion/adverse effects , Activities of Daily Living , Adult , Aged , Disability Evaluation , Female , Follow-Up Studies , Health Status , Humans , Intervertebral Disc Degeneration/surgery , Male , Middle Aged , Patient Satisfaction , Prospective Studies , Spinal Curvatures/surgery , Spinal Fusion/instrumentation , Spondylolisthesis/surgery , Surveys and Questionnaires
5.
Spine (Phila Pa 1976) ; 38(18): E1135-40, 2013 Aug 15.
Article in English | MEDLINE | ID: mdl-23649214

ABSTRACT

STUDY DESIGN: Retrospective comparative cohort analysis. OBJECTIVE: To evaluate the effect of an intraoperative and intensive care unit protocol on incidence of airway complications for patients undergoing combined anterior-posterior cervical decompression and fusion crossing the cervicothoracic junction (CTAPF). SUMMARY OF BACKGROUND DATA: Airway compromise remains an important potential complication for patients undergoing CTAPF. Volume of intravenous fluid replacement perioperatively has been correlated with risk of airway complications in this patient population. METHODS: A retrospective cohort study was performed comparing airway complications (postoperative airway edema requiring reintubation and/or prolonged need for intubation) in patients undergoing CTAPF prior to and after introduction of a standardized protocol. The protocol required limitation of crystalloid fluid resuscitation intraoperatively, with maintenance of blood pressure using vasopressors. Comparisons between the 2 cohorts included operative time, intraoperative blood loss, volume of IV fluid replacement, and incidence of airway complications and dysphagia. RESULTS: Among patients operated prior to establishment of the protocol, 45% (9/20) experienced airway edema requiring extended intubation or reintubation. This rate was reduced to zero among 8 patients operated after the adoption of the protocol (P = 0.029). Intraoperative IV fluid volumes were reduced from 6190 mL to 4802 mL after institution of the protocol (P = 0.016). EBL and total surgical time did not differ between the 2 cohorts (1024 mL vs. 869 mL, P = 0.443; and 6.76 hr vs. 7.18 hr, P = 0.460). Incidence of dysphagia was not significantly different between the 2 cohorts. CONCLUSION: Establishment of a fluid and airway management protocol for patients undergoing CTAPF reduced the incidence of prolonged intubation or reintubation. Given the potentially life-threatening impact of loss of airway patency, intraoperative restriction of IV fluid while maintaining adequate blood pressure may be helpful in increasing the safety of surgical intervention in this complex patient population. LEVEL OF EVIDENCE: 4.


Subject(s)
Airway Management/methods , Cervical Vertebrae/surgery , Decompression, Surgical/methods , Fluid Therapy/adverse effects , Spinal Fusion/methods , Thoracic Vertebrae/surgery , Adult , Aged , Cohort Studies , Crystalloid Solutions , Female , Fluid Therapy/methods , Follow-Up Studies , Humans , Isotonic Solutions/administration & dosage , Male , Middle Aged , Monitoring, Intraoperative/methods , Retrospective Studies
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