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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04867746
Acronym
HamRepair
Enrollment
13
Registered
2021-04-30
Start date
2020-12-02
Completion date
2021-04-15
Last updated
2021-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hamstring Muscle Repair, Hamstring Rupture

Keywords

postoperative muscular imbalances, muscular deficits, pathological gait, Isokinetic muscle strength

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.

Interventions

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

OTHERassessment 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.

OTHERassessment 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.

OTHERassessment 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.

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

Sponsors

University Hospital, Basel, Switzerland
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Isokinetic muscle strengthat 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

MeasureTime frameDescription
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
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
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

Other

MeasureTime frameDescription
EQ-5D-5Lat 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.
Lower Extremity Functional Scale (LEFS)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.
Perth Hamstring Assessment Toolat 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.

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026