Purpose. This prospective, expertise-based randomized clinical trial compares arthroscopic to open shoulder stabilization by measuring the disease-specific quality of life outcome in patients with traumatic unidirectional anterior shoulder instability, and determining the incidence of recurrent instability at 2-years post-operatively. Method. One hundred and ninety-six patients were randomly allocated to arthroscopic (n=98) or open (n=98) repair using an expertise-based approach with a surgeon specializing in one type of surgery. Randomization was performed using computer-generation, variable block sizes and concealed envelopes. Outcomes were measured at baseline, 3 and 6 months, 1 and 2 years post-operatively. These outcomes included the Western Ontario Shoulder Instability (WOSI) Index quality of life outcome and the American Shoulder and Elbow Society (ASES) functional outcome. Both outcomes were measured on a visual analog scale from 0 to 100, where a higher score represents better quality of life or function. Recurrent instability was categorized as traumatic/atraumatic, and as a subluxation/dislocation. Analyses included ANOVA of repeated measures and independent t-tests. Bonferroni adjustments for pairwise contrasts were made for multiple comparisons. Chi-squared analyses were performed on recurrence. Statistical significance was reported at p < 0.05. Results. There were no statistically significant differences at baseline with respect to gender, involved dominant shoulders, age, WOSI or ASES scores. At 2-years post-operatively, 19 patients in the Open group and 14 patients in the Arthroscopic group were lost to follow-up. A comparison of the baseline characteristics of these lost to follow-up patients showed no statistically significant differences in WOSI and ASES scores, age, involved dominant shoulder, gender and presence of Hill Sachs lesions between the groups. Of the patients that completed 2-year follow-up, there was no difference in mean WOSI score between the two groups: Open = 85 (SD = 20; 95% CI = 81 89), Arthroscopic = 82 (SD = 20; 95% CI = 77 86), p = 0.31. The ASES score for the Open group at 2-years was 91 (SD = 13; 95% CI = 88 94) and 88 (SD = 16; 95% CI = 85 92) for the Arthroscopic group, p = 0.17. Recurrence rates at 2-years were statistically different with 11% in the Open (9/80) and 23% in the Arthroscopic (20/87) groups, p = 0.05. Conclusion. At 2-years post-operative follow-up, there was no difference in disease-specific quality of life between Open and Arthroscopic repair. Open repair had a significantly lower risk of recurrence

Our primary objective was to compare healing rates in patients undergoing arthroscopic rotator cuff repair for degenerative tears, with and without bone channeling. Our secondary objectives were to compare disease-specific quality of life and patient reported outcomes as measured by the Western Ontario Rotator Cuff Index (WORC), American Shoulder and Elbow Surgeons (ASES) score and Constant score between groups. Patients undergoing arthroscopic rotator cuff repair at three sites were randomized to receive either bone channeling augmentation or standard repair. Healing rates were determined by ultrasound at 6 and 24 months post operatively. WORC, ASES, and Constant scores were compared between groups at baseline and at 3, 6, 12 and 24 months post operatively. One hundred sixty-eight patients were recruited and randomized between 2013 to 2018. Statistically significant improvements occurred in both groups from pre-operative to all time points in all clinical outcome scores (p < 0 .0001). Intention to treat analysis revealed no statistical differences in healing rates between the two interventions at 24 months post-operative. No differences were observed in WORC, ASES or Constant scores at any time-point. This trial did not demonstrate superiority of intra-operative bone channeling in rotator cuff repair surgery at 24 months post-operative. Healing rates and patient-reported function and quality of life measures were similar between groups

The Banff Patellofemoral Instability Instrument 2.0 (BPII 2.0) is a patient-reported disease-specific quality of life (QOL) outcome measure used to assess patients with recurrent lateral patellofemoral instability (LPI) both pre- and post-operatively. The purpose of this study was to compare the BPII 2.0 to four other relevant patient reported outcome measures (PROMs): the Tampa Scale-11 for kinesiophobia (TSK-11), the pain catastrophizing scale (PCS), a general QOL (EQ-5D-5L), and a return to sport index (ACL-RSI). This concurrent validation sought to compare and correlate the BPII 2.0 with these other measures of physical, psychological, and emotional health. The psychological and emotional status of patients can impact recovery and rehabilitation, and therefore a disease-specific PROM may be unable to consistently identify patients who would benefit from interventions encompassing a holistic and person-focused approach in addition to disease-specific treatment. One hundred and ten patients with recurrent lateral patellofemoral instability (LPI) were assessed at a tertiary orthopaedic practice between January and October 2021. Patients were consented into the study and asked to complete five questionnaires: the BPII 2.0, TSK-11, PCS, EQ-5D-5L, and the ACL-RSI at their initial orthopaedic consultation. Descriptive demographic statistics were collected for all patients. A Pearson's r correlation coefficient was employed to examine the relationships between the five PROMs. These analyses were computed using SPSS 28.0 © (IBM Corporation, 2021). One hundred and ten patients with a mean age of 25.7 (SD = 9.8) completed the five PROMs. There were 29 males (26.3%) and 81 females (73.6%) involving 50% symptomatic left knees and 50% symptomatic right knees. The mean age of the first dislocation was 15.4 years (SD = 7.3; 1-6) and the mean BMI was 26.5 (SD = 7.3; range = 12.5-52.6) The results of the Pearson's r correlation coefficient demonstrated that the BPII 2.0 was statistically significantly related to all of the assessed PROM's (p. There was significant correlation evident between the BPII 2.0 and the four other PROMs assessed in this study. The BPII 2.0 does not explicitly measure kinesiophobia or pain catastrophizing, however, the significant statistical relationship of the TSK-11 and PCS to the BPII 2.0 suggests that this information is being captured and reflected. The preliminary results of this concurrent validation suggest that the pre-operative data may offer predictive validity. Future research will explore the ability of the BPII 2.0 to predict patient quality of life following surgery

Clinical management of patellofemoral (PF) instability is a challenge, particularly considering the wide range of contributing variables that must be taken into consideration when determining optimal treatment. An important outcome measure to consider in this patient population is disease-specific quality of life (QOL). The purpose of this study was to factor analyse and reduce the total number of items in the Banff Patellar Instability Instrument (BPII). Subsequent to the factor analysis, the new, item-reduced BPII 2.0 was tested for validity, reliability and responsiveness. Disease-specific QOL was measured in patients with a confirmed diagnosis of PF instability (n = 223) at the initial consultation with the original BPII. Data from these BPII scores was used to employ a principal component analysis (PCA) to factor analyse and reduce the total number of items in the original BPII, to create the new BPII 2.0. The BPII 2.0 underwent content validation (Cronbach's Alpha, patient interviews and reading-level); construct validation (ANOVA comparing the initial consultation, 6, 12 and 24 month post-operative, Eta squared); convergent validation (Pearson r correlation to the original BPII); responsiveness testing (Eta squared, anchor-based distribution testing); and reliability testing (intra-class correlation coefficient (ICC) 2,k). The original BPII was successfully reduced from 32 to 23 items. The new BPII 2.0 demonstrated excellent Cronbach's Alpha values: initial consult = 0.91; 6-months = 0.96; 12-months = 0.97; and 24-months post-operative = 0.76. Grade-level reading assessment for all items in the BPII 2.0 was below grade twelve. The ANOVA determined the BPII 2.0 was able to discriminate between the initial consultation, 6, 12 and 24 months post-operative assessments, with significant differences between each time-point (p < 0.05). Eta squared was 0.40, demonstrating a medium to large effect size. Convergent validity was established with the BPII 2.0 significantly correlated to the original BPII (initial consult = 0.82, 6-month = 0.90, 12-month = 0.90, and 24-month = 0.94). Anchor-based responsiveness was established with a significant correlation between the 7-point scale of patient-perceived improvement and 24-month post-operative BPII 2.0 scores. Strong reliability was established with an ICC (2,k) = .97. The BPII has undergone a critical step in its psychometric and clinimetric evolution: structural validation. With the work completed in this study, the BPII and BPII 2.0 have completed assessment of seven of the nine Consensus-based Standards for the selection of health Measurement INstruments (COSMIN) properties including: 1) Internal consistency; 2) Reliability; 3) Standard error of measurement; 4) Content validation; 5) Structural validity; 6) Criterion validity; and, 7) Responsiveness testing. Completion of these assessments and the introduction of a structurally valid and shorter questionnaire, the BPII 2.0, provides a definitive level of credibility to this disease-specific outcome measure

Purpose. Electrothermal arthroscopic capsulorrhaphy (ETAC) was a technology introduced for orthopaedic surgery without good scientific clinical evidence supporting its use. This multicentre randomized clinical trial provides the scientific clinical evidence comparing ETAC to Open Inferior Capsular Shift (ICS), by measuring disease-specific quality of life at 2-years post-operatively, in patients with shoulder instability due to capsular redundancy. Method. Fifty-four subjects (37 females and 17 males; mean age 23.3 years (SD = 6.9; 15–44 years) with multidirectional instability (MDI) or multidirectional laxity with antero-inferior instability (MDL-AII) were randomized intra-operatively to ETAC (n = 28) or Open ICS (n = 26) using concealed envelopes, computer-generated, variable block randomization with stratification by surgeon and type of instability. Outcomes were measured at baseline, 3 and 6 months, 1 and 2 years. The Western Ontario Shoulder Instability (WOSI) Index is a quality of life outcome measure that is scored on a visual analog scale from 0 to 100, where a higher score represents better quality of life. Two functional assessments included the American Shoulder and Elbow Society (ASES) Score and the Constant Score. Post-operative recurrent instability and surgical time were also measured. Analyses included ANOVA of repeated measures with Bonferroni adjustments for multiple comparisons, Chi-square and independent t-tests (p < 0.05). Results. At 2-years post-operatively, mean WOSI scores were not statistically different between the groups (p=0.61): ETAC = 74 (SD = 24; 95% CI = 64 84); Open ICS = 77 (SD = 20; 95% CI = 68 86). There was no difference between groups for mean ASES scores (p=0.34): ETAC = 81 (SD = 20; 95% CI = 73 90); Open ICS = 87 (SD = 18; 95% CI = 79 95), mean Constant scores (p = 0.35): ETAC = 83 (SD = 7; 95% CI = 80 86); Open ICS = 85 (SD = 11; 95% CI = 80 − 90), and recurrent instability (p = 0.41): ETAC = 2; Open ICS = 4. Mean surgical time was 23 minutes for ETAC and 59 minutes for Open ICS (p = 0.00). Three subjects (1 ETAC, 2 Open ICS) had stiff shoulders; however, no major complications were observed. Conclusion. Patient outcomes improved from baseline to all follow-up periods. There was no difference between the ETAC and Open ICS groups in quality of life, functional outcomes, and recurrent instability at 2 years post-operatively