With a follow-up of 97%, about one third of the stabilized shoulders experienced at least one redislocation after 8 to 10 years. The presence of a Hill-Sachs defect and the use of less than 3 suture anchors might increase the chance of a redislocation. Patients without a redislocation have a significantly better shoulder function compared with patients with a redislocation.

BackgroundThere is a need for better interpretation of orthopedic treatment effects. Patient-reported outcome measures (PROMs) are already commonly used for patient evaluation. PROMs can be used to determine treatment effects in research as well as in clinical settings by calculating change scores, with pre- and post-treatment evaluation. The smallest detectable change (SDC) and minimal important change (MIC) are two important benchmarks for interpreting these change scores. The purpose was to determine the SDC and the MIC for four commonly used shoulder-related PROMs: Simple Shoulder Test (SST), Disabilities of the Arm, Shoulder and Hand (DASH and QuickDASH), and the Oxford Shoulder Score (OSS).MethodsA cohort of 164 consecutive patients with shoulder problems visiting an orthopedic outpatient clinic completed the SST, DASH, and the OSS at their first visit and 6 months after operative or non-operative treatment. The SDC was calculated with a test re-test protocol (0–2 weeks). For the MIC, change scores (0–6 months of evaluation) were calculated in seven subgroups of patients, according to an additional self-administered ranking of change over time (anchor-based mean change technique). The MIC is defined as the average score of the ‘slightly improved’ group according to the anchor. The QuickDASH was computed from the DASH.ResultsThe SDC of the SST was 2.8, DASH 16.3, QuickDASH 17.1, and OSS 6.0. The MIC change score for the SST was 2.2, DASH 12.4, QuickDASH 13.4, and OSS 6.0.ConclusionThis study shows that on an individual patient-based level, when taking into account SDC and MIC, the change score should exceed 2.8 points for the SST, 16.3 points for the DASH, 17.1 points for the QuickDASH, and 6.0 points for the OSS to have a clinically relevant change on a PROM, which is not due to measurement error.

The statistically significant improvement of KOOS symptom and sport parameters together with the consistently higher, though non-statistically significant, improvement of most other parameters demonstrates that Orthokin clearly induces a biological response different from placebo treatment and warrant future investigations into the possible chondroprotective effect of Orthokin. However, in the current study the primary efficacy objective was not met and, therefore, the use of Orthokin currently cannot yet be recommended for the treatment of OA.

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