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Completed

NCT Number: NCT04867746

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

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.

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Key information

Conditions

Hamstring Muscle Repair Hamstring Rupture

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Orthopaedics and Traumatology, University Hospital Basel

Basel, 4031, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

data collection by health questionnaires

Other

Health questionnaires to assess scores concerning pain and function of the treated leg and overall health

assessment of muscle strength

Other

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.

assessment of gait

Other

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.

assessment of squatting and single leg hops

Other

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.

assessment of postural stability

Other

The length of the centre of pressure path will be measured during two 30-second unipedal stance trials using a force plate.

Primary outcomes

  1. Isokinetic muscle strength

    Time frame: 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 outcomes

  1. Range of motion of the knee (degree)

    Time frame: at baseline (total timeframe for each participant approx 150 minutes)

    Range of motion of the knee in comparison to the contralateral leg

  2. Range of motion of the hip (degree)

    Time frame: at baseline (total timeframe for each participant approx 150 minutes)

    Range of motion of the hip in comparison to the contralateral leg

  3. Joint kinematics (maximum flexion and extension angles)

    Time frame: at baseline (total timeframe for each participant approx 150 minutes)

    Joint kinematics (in walking and running) in comparison to the contralateral leg

  4. Muscle activity (intensity of the electromyographic signals)

    Time frame: 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

Other outcomes

  1. Perth Hamstring Assessment Tool

    Time frame: at baseline (total timeframe for each participant approx 20 minutes)

    The Perth Hamstring Assessment Tool (PHAT) is to evaluate functional outcomes of proximal hamstring re-attachment surgery. The PHAT provides a score out of 100, with a higher score corresponding to higher function. The questionnaire uses a visual analogue scale for pain scores as well as categorical scores for activity levels.

  2. EQ-5D-5L

    Time frame: at baseline (total timeframe for each participant approx 20 minutes)

    The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.

  3. Lower Extremity Functional Scale (LEFS)

    Time frame: at baseline (total timeframe for each participant approx 20 minutes)

    The Lower Extremity Functional Scale (LEFS) is intended to assess functional status in patients with disability of the lower extremity. It is a 20 item questionnaire. The maximum score obtainable is 80 which means complete function and the lowest score is 0 which means very low and severely impaired function.

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Acronym: HamRepair

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 30, 2021
Registry last updated
Dec 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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