Denise Chan

The Development and Validation of a Self-Administered Quality-of-Life Outcome Measure for Young, Active Patients With Symptomatic Hip Disease: The International Hip Outcome Tool (iHOT-33)

PURPOSE The purpose of this study was to develop a self-administered evaluative tool to measure health-related quality of life in young, active patients with hip disorders. METHODS This outcome measure was developed for active patients (aged 18 to 60 years, Tegner activity level ≥ 4) presenting with a variety of symptomatic hip conditions. This multicenter study recruited patients from international hip arthroscopy and arthroplasty surgeon practices. The outcome was created using a process of item generation (51 patients), item reduction (150 patients), and pretesting (31 patients). The questionnaire was tested for test-retest reliability (123 patients); face, content, and construct validity (51 patients); and responsiveness over a 6-month period in post-arthroscopy patients (27 patients). RESULTS Initially, 146 items were identified. This number was reduced to 60 through item reduction, and the items were categorized into 4 domains: (1) symptoms and functional limitations; (2) sports and recreational physical activities; (3) job-related concerns; and (4) social, emotional, and lifestyle concerns. The items were then formatted using a visual analog scale. Test-retest reliability showed Pearson correlations greater than 0.80 for 33 of the 60 questions. The intraclass correlation statistic was 0.78, and the Cronbach α was .99. Face validity and content validity were ensured during development, and construct validity was shown with a correlation of 0.81 to the Non-Arthritic Hip Score. Responsiveness was shown with a paired t test (P ≤ .01), effect size of 2.0, standardized response mean of 1.7, responsiveness ratio of 6.7, and minimal clinically important difference of 6 points. CONCLUSIONS We have developed a new quality-of-life patient-reported outcome measure, the 33-item International Hip Outcome Tool (iHOT-33). This questionnaire uses a visual analog scale response format designed for computer self-administration by young, active patients with hip pathology. Its development has followed the most rigorous methodology involving a very large number of patients. The iHOT-33 has been shown to be reliable; shows face, content, and construct validity; and is highly responsive to clinical change. In our opinion the iHOT-33 can be used as a primary outcome measure for prospective patient evaluation and randomized clinical trials.

A Randomized Clinical Trial Comparing Patellar Tendon, Hamstring Tendon, and Double-Bundle ACL Reconstructions: Patient-Reported and Clinical Outcomes at a Minimal 2-Year Follow-up.

Objective:To compare 3 anatomically positioned autografts for anterior cruciate ligament (ACL) reconstruction, by measuring patient-reported disease-specific quality of life at 2 years postoperatively. Design:Double-blinded, randomized clinical trial with intraoperative computer-generated treatment allocation. Patients and an independent trained evaluator were blinded. Setting:University-based orthopedic referral practice. Patients:Three hundred thirty patients (14-50 years; 183 male patients) with isolated ACL deficiency were equally randomized to: (1) patellar tendon, PT: 28.7 years (SD = 9.7); (2) quadruple-stranded hamstring tendon, HT: 28.5 years (SD = 9.9); and (3) double bundle using HT, DB: 28.3 years (SD = 9.8); 322 patients completed 2-year follow-up. Intervention:Anterior cruciate ligament reconstruction using PT, HT, or DB autografts. Main Outcome Measures:Measured at baseline, 1 and 2 years postoperatively—primary: anterior cruciate ligament quality-of-life scores; secondary: International Knee Documentation Committee (IKDC) scores, KT-1000 arthrometer, pivot shift, range of motion, Tegner activity, Cincinnati Occupational Scale, and single-leg hop. Proportions of correct graft type guesses by the patients and evaluator assessed blinding effectiveness. Results:Baseline characteristics were not different. Anterior cruciate ligament quality-of-life scores increased over time for all groups (P = 0.001) but were not different at 2 years (P = 0.591): PT = 84.6 (SD = 16.6, 95% confidence interval [CI] = 81.4-87.8), HT = 82.5 (SD = 17.7, 95% CI = 79.2-85.9), and DB = 82.4 (SD = 17.5, 95% CI = 79.1-85.7). Two-year KT-1000 side-to-side differences (PT = 1.86 mm; HT = 2.97 mm; DB = 2.65 mm) were statistically significant between PT–HT (P = 0.002) and PT–DB (P = 0.044). The remaining secondary outcomes were not statistically different. Correct graft type guesses occurred 51% of the time for patients and 46% for the evaluator. Conclusions:Two-year disease-specific quality-of-life outcome was not different between the ACL reconstruction techniques. The PT reconstructions had significantly lower side-to-side differences on static stability measures. Patient and evaluator blinding was achieved. Level of Evidence:Level 1 (Therapeutic Studies). Clinical Relevance:This high-quality, large, double-blind randomized clinical trial (RCT) addresses the insufficient evidence in the literature comparing PT, single-bundle hamstring, and DB hamstring reconstructions for ACL rupture in adults. In addition to the clinical and functional results, this RCT uniquely reports on the disease-specific, patient-reported quality-of-life outcome at 2 years postoperatively.

Reruptures, Reinjuries, and Revisions at a Minimum 2-Year Follow-up: A Randomized Clinical Trial Comparing 3 Graft Types for ACL Reconstruction.

Objective:To evaluate the predictive factors for traumatic rerupture, reinjury, and atraumatic graft failure of anterior cruciate ligament (ACL) reconstruction at a minimum 2-year follow-up. Design:Double-blind randomized clinical trial (RCT) with intraoperative computer-generated allocation. Setting:University-based orthopedic referral practice. Patients:Three hundred thirty patients with isolated ACL deficiency were equally randomized to (1) patellar tendon (PT; mean, 29.2 years), (2) quadruple-stranded hamstring tendon (HT; mean, 29.0 years), and (3) double bundle using HT (DB; mean, 28.8 years). Three hundred twenty-two patients completed 2-year follow-up. Interventions:Anatomically positioned primary ACL reconstruction with PT, HT, and DB autografts. Main Outcome Measures:Proportions of complete traumatic reruptures, traumatic reinjuries (complete reruptures and partial tears), atraumatic graft failures, and contralateral ACL tears. Logistic regression assessed 5 a priori determined independent predictors: chronicity, graft type, age, sex, and Tegner level. Results:More complete traumatic reruptures occurred in the HT and DB groups: PT = 3; HT = 7; DB = 7 (P = 0.37). Traumatic reinjuries statistically favored PT reconstructions: (PT = 3; HT = 12; DB = 11; P = 0.05). Atraumatic graft failures were not different: PT = 16; HT = 17; DB = 20 (P = 0.75). Younger age was a significant predictor of complete traumatic reruptures and traumatic reinjuries (P < 0.01). Higher activity level, males, and patients with HT, DB, and acute reconstructions had greater odds of reinjury. None of these factors reached statistical significance. Contralateral ACL tears were not different between groups, but trends suggested that younger females were more likely to have a contralateral ACL tear. Conclusions:More traumatic reinjuries occurred with HT and DB grafts. Younger age was a predictor of complete traumatic rerupture and traumatic reinjury, irrespective of graft type. Level of Evidence:Level 1 (Therapeutic Studies). Clinical Relevance:This article describes the complete traumatic graft rerupture, partial traumatic ACL tear, atraumatic graft failure, and contralateral ACL tear rates observed at 2 years postoperatively in a large double-blind RCT comparing PT, single-bundle hamstring, and double-bundle hamstring ACL reconstructions. The odds and predictive factors of traumatic rerupture and reinjury are also evaluated.

Complications and Adverse Events of a Randomized Clinical Trial Comparing 3 Graft Types for ACL Reconstruction.

Objective:Complications/adverse events of anterior cruciate ligament (ACL) surgery are underreported, despite pooled level 1 data in systematic reviews. All adverse events/complications occurring within a 2-year postoperative period after primary ACL reconstruction, as part of a large randomized clinical trial (RCT), were identified and described. Design:Prospective, double-blind randomized clinical trial. Patients and the independent trained examiner were blinded to treatment allocation. Setting:University-based orthopedic referral practice. Patients:Three hundred thirty patients (14-50 years; 183 males) with isolated ACL deficiency were intraoperatively randomized to ACL reconstruction with 1 autograft type. Graft harvest and arthroscopic portal incisions were identical. Intervention:Patients were equally distributed to patellar tendon (PT), quadruple-stranded hamstring tendon (HT), and double-bundle (DB) hamstring autograft ACL reconstruction. Main Outcome Measures:Adverse events/complications were patient reported, documented, and diagnoses confirmed. Results:Two major complications occurred: pulmonary embolism and septic arthritis. Twenty-four patients (7.3%) required repeat surgery, including 25 separate operations: PT = 7 (6.4%), HT = 9 (8.2%), and DB = 8 (7.3%). Repeat surgery was performed for meniscal tears (3.6%; n = 12), intra-articular scarring (2.7%; n = 9), chondral pathology (0.6%; n = 2), and wound dehiscence (0.3%; n = 1). Other complications included wound problems, sensory nerve damage, muscle tendon injury, tibial periostitis, and suspected meniscal tears and chondral lesions. Overall, more complications occurred in the HT/DB groups (PT = 24; HT = 31; DB = 45), but more PT patients complained of moderate or severe kneeling pain (PT = 17; HT = 9; DB = 4) at 2 years. Conclusions:Overall, ACL reconstructive surgery is safe. Major complications were uncommon. Secondary surgery was necessary 7.3% of the time for complications/adverse events (excluding graft reinjury or revisions) within the first 2 years. Level of Evidence:Level 1 (therapeutic studies). Clinical Relevance:This article reports on the complications/adverse events that were prospectively identified up to 2 years postoperatively, in a defined patient population participating in a large double-blind randomized clinical trial comparing PT, single-bundle hamstring, and DB hamstring reconstructions for ACL rupture.

Validation of Educational Measures in Teaching Shoulder Arthroscopy to Surgical Residents

BACKGROUND Injuries to the shoulder joint commonly require the attention of an orthopedic surgeon. Shoulder arthroscopy plays an increasingly important role in the diagnosis and repair of shoulder pathology; however, the most effective manner in which to teach orthopedic residents fundamental knowledge of diagnostic shoulder arthroscopy before entering the operating room is unclear. We aimed to compare the existing cadaver-based teaching of diagnostic shoulder arthroscopy knowledge with a method that combines model- and video-based teaching to orthopedic surgery residents in a randomized pilot trial. METHODS A composite (model/video teaching) method was designed, using prepared teaching videos and the commercially available ALEX shoulder arthroscopy model. First- and second-year orthopedic surgery residents from the University of Calgary were consented, surveyed for their arthroscopy experience and randomized to either cadaver or composite teaching. Subjects wrote a pretest before their teaching session and a posttest afterwards to assess their knowledge of diagnostic arthroscopy. The tests were multiple choice, containing text and pictorial-based questions. The posttest was modified to minimize recall bias. Subjects were also surveyed for their comments regarding the teaching sessions. RESULTS Nine of 10 subjects increased their test scores after the teaching sessions, with 4 of 5 in the cadaver-based and 5 of 5 in the composite groups. There were no differences between the teaching groups on their mean pre- or posttest scores. The composite group, but not the cadaver-based group, had a statistically significant increase in posttest scores. When the text- and pictorial-based question sections were analyzed separately, both groups significantly improved their mean text-based score, whereas only the composite group increased their mean pictorial-based questions score. Surveying the residents elicited positive comments regarding both manners of teaching. CONCLUSION This pilot trial suggests that a composite teaching curriculum is at least as effective as a cadaver-based environment for teaching orthopedic surgery residents fundamental knowledge of diagnostic shoulder arthroscopy.