Clinical trial NCT04867746: Clinical and Functional Outcomes at Least 2 Years After Hamstring Muscle Repair
Official title: HamRepair: Clinical and Functional Outcomes at Least 2 Years After Hamstring Muscle Repair
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hamstring Muscle Repair
Hamstring Rupture
Keywords: postoperative muscular imbalances
muscular deficits
pathological gait
Isokinetic muscle strength
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2021-04-30
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients treated between 11/2014 and 04/2019 (n=17) with hamstring muscle repair at the Department of Orthopaedics and Traumatology, University Hospital Basel will be contacted at least 2 years after surgery by the treating surgeon.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Isokinetic muscle strength
timeFrame: at baseline (total timeframe for each participant approx 150 minutes)
Secondary outcomes:
measure: Range of motion of the knee (degree)
timeFrame: at baseline (total timeframe for each participant approx 150 minutes)
measure: Range of motion of the hip (degree)
timeFrame: at baseline (total timeframe for each participant approx 150 minutes)
measure: Joint kinematics (maximum flexion and extension angles)
timeFrame: at baseline (total timeframe for each participant approx 150 minutes)
measure: Muscle activity (intensity of the electromyographic signals)
timeFrame: at baseline (total timeframe for each participant approx 150 minutes)
Other outcomes:
measure: Perth Hamstring Assessment Tool
timeFrame: at baseline (total timeframe for each participant approx 20 minutes)
measure: EQ-5D-5L
timeFrame: at baseline (total timeframe for each participant approx 20 minutes)
measure: Lower Extremity Functional Scale (LEFS)
timeFrame: at baseline (total timeframe for each participant approx 20 minutes)
Locations:
city: Basel
country: Switzerland
facility: Department of Orthopaedics and Traumatology, University Hospital Basel
Study officials:
affiliation: Department of Orthopaedics and Traumatology, University Hospital Basel
name: Karl Stoffel, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: