Study report CAMOPED study
Authors: Schraplau A. , Petersen W. , Herbort M. , Lischke B. , Höher J. , Becker R. , Streich N. , Stöckle U. , Schmidt-Lucke C. 
Published: January 2024

1.

The following report was prepared as part of a trial guideline in accordance with Section 137e (1) SGB V to evaluate the benefits of the use of CAM splints for self-application by patients in the post-surgical rehabilitative treatment of ruptures of the anterior cruciate ligament.

The primary aim of the study project was to test the hypothesis that rehabilitation with CAMOped in addition to standardised rehabilitation (intervention group, IG) is superior to standardised rehabilitation alone (control group, KG) in terms of knee joint function measured with the sIKDC (subjective assessment) at 6 weeks post surgery (FU2) compared to the time of assessment immediately post-surgical (T4).

Between June 2020 and January 2023, 105 patients (m:w 62:43, age 33 ± 11 years) were randomised in a stratified manner (50 IG and 55 KG) and included in the study, which was evaluated using an intention-to-treat (ITT) approach. 88 subjects had a simple anterior cruciate ligament rupture, 17 subjects also received a meniscal intervention. The study was discontinued for ethical reasons when the CPM splint was included in standard care and thus not carried out in accordance with the protocol for the CG in January 2023.

There were 87 usable data sets (42 IG and 45 KG) for analysing the primary research question. With regard to the relevant preoperative influencing variables (age, Tegner score, injury, sex ratio or oIKDC) at the time of study inclusion (T0), both study groups were equal. In the IG, 5 patients received an additional meniscus intervention (10% of the IG), while in the KG the proportion was 22% with 12 patients.

The CAM splint was used for a period of 3 weeks preoperatively and 6 [5-7] weeks post-surgical.

At post surgery discharge (time point T4), knee joint function (sIKDC) was significantly higher (higher knee joint function) in the IG compared to the KG (n=87, 33.0 [23.0 - 46.0] vs. 28.0 [21.0 - 33.0], p=0.024). Three weeks post-surgical (FU1, n=85), knee joint function was the same in both groups. At the time of the follow-up examinations after 6 weeks (FU2, time of recording the primary endpoint), there was no difference in the sIKDC score between the intervention and control groups (n=87, 56.5 [48.0 - 64.0] vs. 54.0 [48.0 - 63.0], p=n.s.).

The prespecified analysis, in which the change at the follow-up time after 6 weeks post-surgical (FU2) was analysed in relation to the assessment at post surgery discharge (T4), showed that the absolute change in knee joint function was significantly lower in the IG (n= 42) than in the KG (24.5 [12.0 - 31.0] vs. 29.0 [18.0 - 35.0], p=0.041). After 12 weeks (FU3), the subjective knee joint function was identical in both treatment groups. During the one-year follow-up period, 91 adverse events occurred, including 8 serious adverse events, each unrelated to the investigational product.

From 12/2021 - the date on which the CPM splint was included in standard care - the high number of refusals to participate in a study without CPM splints in the control group by patients and the number of protocol violations and dropouts was striking. After conducting the interim analysis on 19 September 2022 and subsequent discussion with the LKP and the principal investigators, this led to the principal investigator discontinuing the study for ethical reasons. A respective letter in german from the PI to the sponsor of the study can be requested from the study contact.