Clinical trial about the after-treatment of anterior cruciate ligament reconstruction using hamstring tendons with and without wearing an orthosis - a prospective randomized study

Status:

completed 04/2020

Aims:

The primary research objective is to evaluate the knee function measured by subjective and objective International Knee Documentation Committee (IKDC) 2000 score.

Secondary targets are the period of disability, the quality of life (SF36), as well as the Tegner and Lysholm Score in the after-treatment of anterior cruciate ligament reconstruction using hamstring tendons with and without wearing an orthesis.

Activities/Methods:

During a prospective randomized clinical trial with 114 patients comparing the results of rehabilitation with and without wearing a brace after reconstruction of an isolated ACL-rupture (anterior cruciate ligament). A total of 58 patients were treated with a hard frame brace for 6 weeks after surgery (group 1) and 56 without brace (group 2). In a follow-up period of one year, the patients were examined pre- and postoperatively five times (6 weeks, 4 months, 6 and 12 months). The primary research objective is the subjective IKDC 2000. Secondary research goals are the objective IKDC 2000, the Lysholm knee score, the Tegner Activity Score, the assessment of quality of life (SF 36), isokinetic tests, arthrometer measurements as well as jump and running tests.

The results of both groups are statistically analyzed for non-inferiority.

Results:

In the follow-up period of 12 months, both groups presented an improvement in subjective IKDC up to good performances. There was no significant difference between the two groups). Furthermore, no significant difference can be detected between the two groups in subjective Lysholm score. After 12 months the isokinetic force deficit of the knee extensors was 15% +/- 15 in group 1 and 17% +/- 20 in group 2 at a movement speed of 60 degrees/second. Thus, there is no significant difference in strength.

With regard to the parameters we measured, after ACL-reconstruction using the hamstring tendons there was no significant difference in rehabilitation with or without wearing a hard frame brace. Thus, in our opinion, post-treatment with a hard frame brace can be omitted after ACL-reconstruction.

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