Diagnostic Accuracy of Pre-operative Percutaneous Synovial Biopsy and Aspirate Compared with Open Biopsy for Prosthetic Shoulder Infections.

BACKGROUND: Shoulder arthroplasty revision is associated with a high prevalence of prosthetic infection, and diagnosis remains difficult. The primary aim of the study was to determine the diagnostic accuracy of percutaneous synovial biopsy (PSB) and joint aspiration compared with open culture results in detecting infection in revision shoulder arthroplasty. The second aim was to determine whether biopsy location within the shoulder was associated with culture status. METHODS: This was a multicenter prospective cohort study involving four sites and 69 patients undergoing revision shoulder arthroplasty. The cohort was 57% female with a mean age of 64 years. Preoperative fluoroscopic-guided PSB's and aspirates were carried out by a musculoskeletal radiologist prior to revision shoulder arthroplasty. The original prostheses consisted of hemiarthroplasties, total shoulder arthroplasties (TSA), resurfacing TSA, reverse shoulder arthroplasties (RSA), and antibiotic spacers. Six synovial tissue biopsies from separate regions in the shoulder were obtained both preoperatively and intra-operatively. The shoulder joint was aspirated, and synovial fluid collected, if available. Infection was considered positive in the setting of two or more matching positive cultures. The PSB cultures were considered "true positive" if the PSB cultures matched the open biopsy cultures. RESULTS: Nineteen percent had positive infection based on PSB and 23% had confirmed culture positive infections based on intra-operative biopsy. The diagnostic accuracy of PSB compared with open biopsy was as follows: sensitivity 0.37 (95% CI 0.13-0.61), specificity 0.81 (95% CI 0.7-0.91), positive predictive value 0.37 (95% CI 0.13 - 0.61), negative predictive value 0.81 (95% CI 0.70-0.91), positive likelihood ratio 1.98 and negative likelihood ratio 0.77. Of the 71 patients, aspiration yielded synovial fluid in 33 patients. Preoperative aspirates detected no infections confirmed positive by open biopsy and correctly identified 81% of absent infections. The diagnostic accuracy of aspirates compared with open biopsy was as follows: sensitivity 0%, specificity 0.81 (95% CI 0.66-0.96), positive predictive value 0%, negative predictive value 0.78 (95% CI 0.63-0.93). Biopsy location within the shoulder was not associated with infection status. DISCUSSION: Preoperative aspiration detected none of the infections proven positive via open biopsy. Although PSB was superior to synovial fluid aspirate, poor likelihood ratios suggests that PSB is not useful as an isolated test in the preoperative workup of the potentially infected patient. Biopsy location was not associated with culture status suggesting that the capsule is uniformly infected, and the location of tissue biopsies does not appear to matter.

Bone channeling in arthroscopic rotator cuff repair: a systematic review and meta-analysis of level I studies.

BACKGROUND: There is ongoing controversy regarding the effect of bone channeling in arthroscopic rotator cuff repair. Since the most recent systematic reviews in 2019, several large high-level trials have been completed. This study assessed all available level I randomized controlled trials (RCTs) that compared arthroscopic rotator cuff repair with and without bone marrow channeling. METHODS: A systematic search of the Ovid MEDLINE, Embase, and Cochrane Library databases was conducted through mid January 2023. Two reviewers performed screening of studies meeting the eligibility criteria: English-language RCTs in patients aged ≥18 years comparing arthroscopic rotator cuff repair of full-thickness tears with and without bone marrow channeling (channeling group and control group, respectively). Functional scores, pain, healing rates, and reoperations were reviewed using pooled analysis where appropriate. The methodologic quality of included studies was assessed using the Cochrane risk-of-bias tool and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. RESULTS: A total of 6 randomized studies (N = 593) met the inclusion criteria. Pooled analysis of all 6 studies showed no significant mean difference in function (1.32; 95% confidence interval [CI], -0.63 to 3.26), as measured by the Constant-Murley score. Retear rates were also not statistically different between groups (risk ratio, 0.99; 95% CI, 0.57 to 1.71), with pooled retear rates of 19.6% (48 of 245) with channeling and 19.8% (51 of 257) without. The other outcomes of interest were only available for analysis in a subset of studies. There were no standardized mean differences in pain (0.09; 95% CI, -0.18 to 0.36), and there were similar reoperation rates (risk ratio, 1.19; 95% CI, 0.43 to 3.34) in the channeling and control groups. For the included studies, the overall quality of evidence by outcome was judged to be moderate (function, pain, and reoperations) or low (retear rates), mainly owing to risk of bias (all outcomes) and inconsistency (retear rates). CONCLUSION: The results of this study refute the findings of prior systematic reviews that showed that channeling reduces the retear rate when combined with arthroscopic rotator cuff repair. This meta-analysis of level I evidence, including recent larger RCTs, demonstrates that bone marrow stimulation in the setting of primary arthroscopic rotator cuff repair has no significant effect on functional outcomes, healing, pain, or reoperation rates.

Intraoperative Channeling in Arthroscopic Rotator Cuff Repair: A Multicenter Randomized Controlled Trial.

BACKGROUND: Despite recent advances in arthroscopic rotator cuff repair, the retear rate remains high. New methods to optimize healing rates must be sought. Bone channeling may create a quicker and more vigorous healing response by attracting autologous mesenchymal stem cells, cytokines, and growth factors to the repair site. HYPOTHESIS: Arthroscopic rotator cuff repair with bone channeling would result in a higher healing rate compared with arthroscopic rotator cuff repair without adjuvant channeling. STUDY DESIGN: Randomized controlled trial; Level of evidence, 1. METHODS: Our primary objective was to compare healing rates in patients undergoing arthroscopic rotator cuff repair for degenerative tears, with and without bone channeling. Secondary objectives included comparisons of the Western Ontario Rotator Cuff Index (WORC) score, American Shoulder and Elbow Surgeons (ASES) score, Constant score, Constant strength subscore, and visual analog scale (VAS) for pain score between groups. Patients undergoing arthroscopic rotator cuff repair were recruited at 3 sites and were randomized to receive either bone channeling augmentation or standard repair. Healing was determined via ultrasound at 24 months postoperatively. WORC, ASES, and Constant scores were compared between groups at baseline and at 3, 6, 12, and 24 months postoperatively. RESULTS: A total of 168 patients were enrolled between 2013 and 2018. Intention-to-treat analysis revealed no statistical differences in healing rates between the 2 interventions at 24 months postoperatively. Statistically significant improvements occurred in both groups from preoperatively to all time points for the WORC, the ASES score, the Constant score or Constant strength subscore, and the VAS for pain (P < .0001). No differences were observed between the bone channeling and control groups in WORC, ASES, Constant, and VAS pain scores at any time point. CONCLUSION: This trial did not demonstrate the superiority of intraoperative bone channeling in rotator cuff repair over standard rotator cuff repair at 24 months postoperatively. Healing rates, patient-reported function, and quality-of-life outcomes were similar between groups. REGISTRATION: NCT01877772 (ClinicalTrials.gov identifier).

Ultrasound-determined healing rates with subscapularis tenotomy versus peel after anatomic shoulder arthroplasty.

BACKGROUND: Several techniques have been described for mobilizing the subscapularis tendon in anatomic total shoulder arthroplasty (TSA). The purpose of this study was to compare subscapularis tendon healing rates, as determined by ultrasound, in patients following anatomic TSA with either a subscapularis tenotomy or subscapularis peel. METHODS: This study was a secondary analysis of patients from a previous randomized controlled trial in which patients underwent anatomic TSA and were randomized to either a tenotomy or peel approach. The primary outcome was postoperative tendon healing rates determined on ultrasound at >12 months after surgery. Secondary outcomes included postoperative tendon thickness measured on ultrasound; elbow position (neutral alignment in the belly-press position vs. posterior); internal rotation function measured with the third and fourth questions of the American Shoulder and Elbow Surgeons questionnaire; and Western Ontario Osteoarthritis of the Shoulder index. Radiographs were analyzed in patients with torn tendons. RESULTS: One hundred patients were randomized to a tenotomy (n = 47) or peel (n = 53) approach. Postoperative ultrasound results were available in 88 patients. Tendon healing rates were 95% for tenotomy vs. 75% for peel (P = .011). The mean postoperative tendon thickness was 4 mm (standard deviation, 1.0 mm) and 4 mm (standard deviation, 1 mm) in the tenotomy and peel groups, respectively (P = .37). Internal rotation function was not associated with healing status (P = .77 and P = .22 for questions 3 and 4, respectively, of the American Shoulder and Elbow Surgeons questionnaire), nor was elbow position (P = .2) in the belly-press position. DISCUSSION: We observed that subscapularis tenotomy had a higher healing rate than peel as determined by ultrasound in TSA patients. There was no statistically significant difference in postoperative tendon thickness in intact tendons as measured on ultrasound when comparing subscapularis mobilization techniques, nor was there any association between healing status and internal rotation function or elbow position.

A Multicenter Randomized Controlled Trial Comparing Single-Row With Double-Row Fixation in Arthroscopic Rotator Cuff Repair: Long-Term Follow-up.

BACKGROUND: The long-term outcomes of single- versus double-row fixation in arthroscopic rotator cuff repair are not currently known. PURPOSE: To compare the treatment effects of the single- versus double-row suture technique in arthroscopic rotator cuff repair of full-thickness tears at 10-year follow-up. STUDY DESIGN: Randomized controlled trial; Level of evidence, 1. METHODS: Patients were evaluated at 10 years postoperatively. The primary outcome measure was the Western Ontario Rotator Cuff Index (WORC). Secondary outcome measures included the American Shoulder and Elbow Surgeons (ASES) score, Constant score, strength, and incidence of revision surgery. Ultrasound was used to evaluate the rotator cuff to determine repair integrity. Statistical analyses consistent with those of the main trial were conducted. RESULTS: Of the original 90 participants, 77 (85%) returned at a mean follow-up of 10 years. At ten year follow-up, the WORC score was higher in the double row group (79.9 [95% CI, 16.2 to 99.1]) compared with the single row group (72.9, [95% CI, 4.3 to 100]), P = .020. From baseline to 2 years, the mean change in WORC scores for the single-row group was -48.5 compared with -40.6 for the double-row group, with a between-group difference of -7.8 (95% CI, -20.4 to 4.7). From 2 to 10 years, the change in WORC scores for the single-row group was 11.5 compared with -0.2 for the double-row group, with a between-group difference of 11.7 (95% CI, -0.7 to 24.3). From baseline to 10 years, the mean between-group difference was 3.9 (95% CI, -7.8 to 15.6). Similarly, a decrease in ASES scores was observed between 2 and 10 years for the single-row group (9.2 [95% CI, 0.9 to 17.5]; P = .029), with a nonsignificant decrease in ASES scores for the double-row group (6.2 [95% CI, -3.2 to 15.6]; P = .195) as well as a decrease in Constant scores for both the single- (9.5 [95% CI, 1.4 to 17.5]; P = .020) and double-row (14.4 [95% CI, 5.6 to 23.3]; P = .001) groups. Overall, 3 participants developed a full-thickness tear after 2 years: 2 from the double-row group and 1 from the single-row group. One participant from each study group underwent revision surgery after the 2-year time point. CONCLUSION: A statistically significant (but likely not clinically important) difference in WORC scores was seen at 10-year follow-up in favor of double-row fixation. Between baseline and 10-year follow-up, a decrease in most outcome scores was observed in both the single- and the double-row groups. REGISTRATION: NCT00508183 (ClinicalTrials.gov identifier).

Preoperative bone marrow stimulation does not improve functional outcomes in arthroscopic cuff repair: a prospective randomized controlled trial.

AIMS: Despite recent advances in arthroscopic rotator cuff repair, re-tear rates remain high. New methods to improve healing rates following rotator cuff repair must be sought. Our primary objective was to determine if adjunctive bone marrow stimulation with channelling five to seven days prior to arthroscopic cuff repair would lead to higher Western Ontario Rotator Cuff (WORC) scores at 24 months postoperatively compared with no channelling. METHODS: A prospective, randomized controlled trial was conducted in patients undergoing arthroscopic rotator cuff repair. Patients were randomized to receive either a percutaneous bone channelling of the rotator cuff footprint or a sham procedure under ultrasound guidance five to seven days prior to index surgery. Outcome measures included the WORC, American Shoulder and Elbow Surgeons (ASES), and Constant scores, strength, ultrasound-determined healing rates, and adverse events. RESULTS: Overall, 94 patients were randomized to either bone channelling or a sham procedure. Statistically significant improvements in all clinical outcome scores occurred in both groups from preoperative to all timepoints (p < 0.001). Intention-to-treat analysis revealed no statistical differences in WORC scores between the two interventions at 24 months postoperatively (p = 0.690). No differences were observed in secondary outcomes at any timepoint and healing rates did not differ between groups (p = 0.186). CONCLUSION: Preoperative bone channelling one week prior to arthroscopic rotator cuff repair was not associated with significant improvements in WORC, ASES, Constant scores, strength, or ultrasound-determined healing rates. Cite this article: Bone Joint J 2021;103-B(1):123-130.

Effectiveness of Immersive Virtual Reality on Orthopedic Surgical Skills and Knowledge Acquisition Among Senior Surgical Residents: A Randomized Clinical Trial.

Importance: Video learning prior to surgery is common practice for trainees and surgeons, and immersive virtual reality (IVR) simulators are of increasing interest for surgical training. The training effectiveness of IVR compared with video training in complex skill acquisition should be studied. Objectives: To evaluate whether IVR improves learning effectiveness for surgical trainees and to validate a VR rating scale through correlation to real-world performance. Design, Setting, and Participants: This block randomized, intervention-controlled clinical trial included senior (ie, postgraduate year 4 and 5) orthopedic surgery residents from multiple institutions in Canada during a single training course. An intention-to-treat analysis was performed. Data were collected from January 30 to February 1, 2020. Intervention: An IVR training platform providing a case-based module for reverse shoulder arthroplasty (RSA) for advanced rotator cuff tear arthropathy. Participants were permitted to repeat the module indefinitely. Main Outcomes and Measures: The primary outcome measure was a validated performance metric for both the intervention and control groups (Objective Structured Assessment of Technical Skills [OSATS]). Secondary measures included transfer of training (ToT), transfer effectiveness ratio (TER), and cost-effectiveness (CER) ratios of IVR training compared with control. Additional secondary measures included IVR performance metrics measured on a novel rating scale compared with real-world performance. Results: A total of 18 senior surgical residents participated; 9 (50%) were randomized to the IVR group and 9 (50%) to the control group. Participant demographic characteristics were not different for age (mean [SD] age: IVR group, 31.1 [2.8] years; control group, 31.0 [2.7] years), gender (IVR group, 8 [89%] men; control group, 6 [67%] men), surgical experience (mean [SD] experience with RSA: IVR group, 3.3 [0.9]; control group, 3.2 [0.4]), or prior simulator use (had experience: IVR group 6 [67%]; control group, 4 [44%]). The IVR group completed training 387% faster considering a single repetition (mean [SD] time for IVR group: 4.1 [2.5] minutes; mean [SD] time for control group: 16.1 [2.6] minutes; difference, 12.0 minutes; 95% CI, 8.8-14.0 minutes; P < .001). The IVR group had significantly better mean (SD) OSATS scores than the control group (15.9 [2.5] vs 9.4 [3.2]; difference, 6.9; 95% CI, 3.3-9.7; P < .001). The IVR group also demonstrated higher mean (SD) verbal questioning scores (4.1 [1.0] vs 2.2 [1.7]; difference, 1.9; 95% CI, 0.1-3.3; P = .03). The IVR score (ie, Precision Score) had a strong correlation to real-world OSATS scores (r = 0.74) and final implant position (r = 0.73). The ToT was 59.4%, based on the OSATS score. The TER was 0.79, and the system was 34 times more cost-effective than control, based on CER. Conclusions and Relevance: In this study, surgical training with IVR demonstrated superior learning efficiency, knowledge, and skill transfer. The TER of 0.79 substituted for 47.4 minutes of operating room time when IVR was used for 60 minutes. Trial Registration: ClinicalTrials.gov Identifier: NCT04404010.