ClinicalTrials.gov identifier: NCT01692756.
Anterior cruciate ligament (ACL) injuries are common and lead to posttraumatic osteoarthritis (PTOA) in a high percentage of patients. Research has been ineffective in identifying successful treatment options for people suffering from symptomatic PTOA resulting in a shift of focus toward the young, ACL injured patients at risk of developing PTOA. Randomized clinical trials examining the very early phase after ACL injury are ideal to study this population; however, these trials face significant challenges regarding recruitment as well as reproducibility of patient-reported outcomes (PROs) and inflammatory and/or chondrodegenerative biomarkers associated with early PTOA. The aim of this work was to develop an approach to allow for early recruitment into an RCT for early treatment following ACL injury and to analyze the variability of commonly used measures and biomarkers at various time points after injury. This paper reports the study design and data related to the first month of treatment for the placebo group of an ongoing 2-year clinical trial to evaluate the effect of an early intra-articular intervention after ACL injury. The results of this study suggest that acute ACL injury results in early changes of both inflammatory and chondrodegenerative biomarkers. These results also provide vital information for researchers to consider when developing future protocols, both related to the logistics of early patient enrollment as well as the appropriate timing of biomarker and patient-reported outcome collection. © 2016 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 35:641-650, 2017.
Despite being frequently used in the research community, the Constant score may be less clinically useful as it was less responsive. Additionally, it is a greater burden on the provider because it requires objective strength and range of motion data to be gathered by the clinician. In contrast, the ASES score was highly responsive after rotator cuff repair and requires only subjective patient input. Furthermore, separate PRO scoring methods appear to be necessary for patients undergoing rotator cuff repair and surgery for instability as the instability-specific Rowe score was much more responsive than the ASES score.
Background: Our aim was to discern whether children with amputations have differences in subjective function based on amputation level. We hypothesized that children with more proximal amputations would report poorer function and quality of life. Methods: An IRB-approved, retrospective chart review of patients aged 0 to 21 years old with lower extremity amputations was performed. Demographic information, type of amputation, type of prosthesis, and the Pediatric Outcomes Data Collection Instrument (PODCI) was collected from parents and children (above 10 y old). Patients were divided into 4 groups based on the level of amputation (ankle; transtibial; knee; transfemoral), and PODCI scores were compared between groups. PODCI subscores were also compared between unilateral versus bilateral amputations, high-demand versus low-demand prostheses, and congenital versus acquired amputations. Results: We identified 96 patients for analysis (39 ankle, 21 transtibial, 27 knee, and 9 transfemoral amputations). The sports/physical functioning subscale of the PODCI showed the only statistically significant difference between amputation level and outcome with ankle-level amputations reporting higher scores than knee-level amputations (parent: 78.3±16.4 vs. 60.0±25.3, P=0.006; child: 87.4±15.3 vs. 65.4±31.5, P=0.03). Although not significantly different from either the ankle, knee, or transfemoral groups, patients with transtibial amputations reported intermediate scores (parent: 68.5±27.5; child: 78.9±25.5). There were no significant differences among amputation level for PODCI transfers, pain/comfort, global function, or happiness subscales. In subgroup analysis, same-level congenital amputees had similar scores to acquired amputees (P>0.05). When compared with unilateral knee amputations patients, patients with bilateral knee amputations had significantly worse transfer (62.4 vs. 88.3; P=0.02), sports/physical functioning (34.2 vs. 66.2; P=0.01), and global domains (58.4 vs. 80.5; P=0.02). Conclusions: Subjective sports and physical functioning of pediatric amputees were significantly worse after knee amputation when compared with ankle-level amputations. Although not statistically significant at all levels, our data suggest a graded decline in sports/physical functioning with higher level amputations. Amputation level did not affect pain, happiness, or basic mobility. Level of Evidence: Level III.
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