Clinical and Functional Outcomes at Least 2 Years After Hamstring Muscle Repair

Completed

• Conditions: Hamstring Muscle Repair; Hamstring Rupture

• Registration Number: NCT04867746
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief Summary

This study is to evaluate functional outcomes of a new, intraoperative lateral positioning of the anchors on the tuber ischiadicum, in comparison to regular anatomical anchoring direct on top of the tuber ischiadicumafter hamstring muscle repair. This study is to quantify at least 2 years postoperative functional, biomechanical and clinical outcomes including side-to-side differences in muscle strength, unipedal balance, gait, jumping and squatting function, muscle activity, in patients treated by hamstring muscle repair.

Detailed Description

The design of this pilot study is a descriptive cross-sectional single centre analysis involving all patients previously treated with hamstring repair. All of these patients will be asked to participate in clinical and detailed functional analysis at least 2 years after surgery. Specifically, biomechanical and functional data including isokinetic muscle strength, clinical scores, ROM, joint kinematics and kinetics during walking, running, squatting and single leg jumps, muscle activity and single leg balance ability in the affected and contralateral leg will be collected. These parameters will be compared between legs and correlated with clinical scores.

Study Timeline

• Study Start: 2020-12-02
• Primary Completion: 2021-04-15
• Study Completion: 2021-04-15
• Study First Submitted: 2021-04-27
• Study First Submitted QC: 2021-04-27
• Study First Posted: 2021-04-30
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-07
• Last Update Posted: 2021-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

• At least 2 years since hamstring muscle repair

Exclusion Criteria

• Revision surgery within 6 months before testing on the ipsilateral knee and hip
• BMI > 35 kg/m2
• Previous injury and surgical procedures of the contralateral knee and hip within the last year
• Neuromuscular disorders affecting lower limb movement
• Additional pathologies that influence the mobility of the lower extremity
• Inability to provide informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Isokinetic muscle strength	at baseline (total timeframe for each participant approx 150 minutes)	Isokinetic muscle strength deficit of the knee flexors and extensors in the injured leg compared to the contralateral leg, assessed by a dynamometer

Secondary Outcome Measures

Name	Time	Method
Range of motion of the hip (degree)	at baseline (total timeframe for each participant approx 150 minutes)	Range of motion of the hip in comparison to the contralateral leg
Muscle activity (intensity of the electromyographic signals)	at baseline (total timeframe for each participant approx 150 minutes)	Muscle activity (in gait, balance, squatting and single leg hopping) in comparison to the contralateral leg
Range of motion of the knee (degree)	at baseline (total timeframe for each participant approx 150 minutes)	Range of motion of the knee in comparison to the contralateral leg
Joint kinematics (maximum flexion and extension angles)	at baseline (total timeframe for each participant approx 150 minutes)	Joint kinematics (in walking and running) in comparison to the contralateral leg

Trial Locations

Locations (1)

Department of Orthopaedics and Traumatology, University Hospital Basel; 🇨🇭 Basel, Switzerland