Impact of muscular stability and type of rehabilitation on clinical outcomes after tibial plateau fractures

Status:

ongoing

Aims:

The objective of the present study is to investigate the impact of muscular stability on clinical outcomes after tibial plateau fractures (TPF), as well as to evaluate the effects of rehabilitation intensity and the use of supportive devices.

Activities/Methods:

Study Design

The clinical trial is structured into two work packages. Work Package 1 comprises a retrospective, non-interventional, single-group, multi-center study. Work Package 2 is designed as a prospective, interventional, randomized, parallel-group, multi-center study with subsequent subgroup stratification.

Work Package 1 (Retrospective Study): Patient-reported outcome measures (PROMs) will be collected from patients who underwent surgical treatment of tibial plateau fractures (TPF) between 2017 and 2023. Eligible fractures include AO type B and C fractures treated with plate osteosynthesis. Exclusion criteria are AO type A (insignificant) fractures and patients with previous or concomitant injuries of the affected knee joint.

The primary outcome measures are functional outcome scores assessed at follow-up using validated instruments: Knee Injury and Osteoarthritis Outcome Score (KOOS), Lysholm Score, International Knee Documentation Committee (IKDC) subjective knee form, SF-36, and Visual Analog Scale (VAS) for pain. Secondary outcome measures include time to return to work, time to return to sports (recreational activity and baseline fitness level), and documentation of the rehabilitation program completed immediately after discharge from inpatient care.

Work Package 2 (Prospective Interventional Study): Patients requiring surgical treatment of a tibial plateau fracture will be prospectively enrolled at the time of hospital admission and randomized postoperatively into two study arms. Patients in study arm A will receive, in addition to standard physiotherapy, a motorized continuous passive motion (CPM) device and electromyostimulation training (EMS) during the first six weeks after osteosynthesis. Patients in study arm B will receive standard physiotherapy only, without CPM and EMS.

At twelve weeks postoperatively, patients will be further stratified into subgroups within each study arm according to the number of therapy hours completed after discharge from the initial inpatient stay. Participants with more than 25 therapy hours will be assigned to subgroup A1 (or B1), while participants with fewer than 25 therapy hours will be assigned to subgroup A2 (or B2).

In addition to the questionnaires described in Work Package 1, participants in Work Package 2 will undergo surface electromyography (EMG) and gait analysis to identify potential muscular imbalances. Furthermore, isokinetic strength testing will be performed. These assessments will take place at 6 weeks, 12 weeks, and 12 months after recruitment. Additionally, magnetic resonance imaging (MRI) of the knee joint will be performed at baseline and at 12 months postoperatively.

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