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

Study Overview
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Brief Summary
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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
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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.

Official Title
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HamRepair: Clinical and Functional Outcomes at Least 2 Years After Hamstring Muscle Repair

Conditions
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Hamstring Muscle Repair, Hamstring Rupture

Intervention / Treatment
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* Other: data collection by health questionnaires
* Other: assessment of muscle strength
* Other: assessment of gait
* Other: assessment of squatting and single leg hops
* Other: assessment of postural stability


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: data collection by health questionnaires|Health questionnaires to assess scores concerning pain and function of the treated leg and overall health|
|Other: assessment of muscle strength|Muscle strength will be measured bilaterally using a dynamometer (Biodex System 4 Pro: Biodex Medical Systems, Shirley, NY, USA). For the knee, maximum isokinetic flexion and extension torques will be collected between full extension and full flexion at a movement speed of 60°/s (5 repetitions) and 240°/s (15 repetitions). Maximum joint torques in each movement direction will be recorded for each joint and normalized to body weight.|
|Other: assessment of gait|Instrumented gait analysis on a treadmill with an embedded plantar pressure plate (h/p/cosmos, Zebris FDM-T, Isny, Germany; 7168 sensors; area, 1.5 * 0.5 m; range, 1-120 N/cm2; precision, 1-120 N/cm2 ± 5%; sampling rate, 120 Hz) and on an overground walkway with two embedded force plates (Kistler force plate 9260AA6, Kistler AG, Winterthur, Switzerland; sampling rate 2400 Hz). Simultaneously with the plantar pressure or force data, kinematic and electromyographic (EMG) data will be collected. Participants will then walk for 1 minute at their preferred walking speed (0% slope and at 15% slope) and at 1.2 m/s (0% slope). For all conditions, kinematic, EMG and pressure data will be recorded for 1 minute. Subsequently, the treadmill speed will be increased to preferred running speed and 2.3 m/s (0% slope), and data for 1 minute running will be recorded. Subjects will then complete overground walking and running trials on the walkway with embedded force plates.|
|Other: assessment of squatting and single leg hops|Participants perform three jumps on a force plate. Maximum jump length, Maximum flexion and extension angles and joint moments will be identified. Subsequently, participants perform three squats onto two force plates (one per foot). On- and off times will be computed for each muscle and condition.|
|Other: assessment of postural stability|The length of the centre of pressure path will be measured during two 30-second unipedal stance trials using a force plate.|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postoperative muscular imbalances, muscular deficits, pathological gait, Isokinetic muscle strength