Functional performance after Ligamys Surgery, a case -matched study

Rationale:

In the Netherlands, between 8000-9000 ACL reconstructions are performed annually. Contemporary use is made of two surgical techniques, namely the Hamstring graft (HS) and bone-patellar tendon-bone graft (BPTB). This transplant has been the gold standard in recent years when it comes to reconstruct the anterior cruciate ligament. New insights into the knee surgery show that it is possible to repair the anterior cruciate ligament. Recent studies have shown that a self-healing process is possible in the anterior cruciate ligament. In addition to the BPTB and hamstring tendon graft, nowadays a new technique is used, namely dynamic intraligamentary stabilization or Ligamys. The Ligamys methode preserves the native ACL tissue, which contains the sensory nerve fibers, theoretically this will leed to a better proprioception.

Objective:

The primary purpose of this study is to assess non-inferiority in functional performance of the knee after Ligamys surgery compared to healthy controls at one to two years after surgery.

Study design:

This research concerns a cross-sectional non-inferiority case-matched study in subjects who have been operated using the Ligamys method, compared with a healthy case-matched control group.

Study population:

The population consists of patients who have undergone a Ligamys surgery at least one year post surgery and case matched healthy controls. The aim is to include 48 patients in both groups.

Main study parameters/endpoints:

The main endpoint in this study is the Limb Symmetry Index (LSI) of the single hoptest for distance to identify functional assymetry. Seconday, the study will use single leg triple hop test, the side hop test, and The Joint Position Sense Test to assess proprioception. Additionally patients will fill out the IKDC and Tegner Activity Scale.

The primary goal of this study is to describe the functional performance tests of successfully treated Ligamys patients and compare this to healthy controls. The expectation with this research is that the Ligamys method meets the 90% LSI on the hop tests one to two year after surgery.

single observation: all measurements will be performed between sept 2018 and sept 2019

None.