Hamstring Muscle RepairHamRepairNCT04867746
Clinical and Functional Outcomes at Least 2 Years After Hamstring Muscle Repair
An observational study of Hamstring Muscle Repair and Hamstring Rupture, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hamstring Muscle Repair, Hamstring Rupture
- What is being tested?
- data collection by health questionnaires, assessment of muscle strength and assessment of gait
- How many people
- 13 participants
- Where
- 1 siteSwitzerland
- Study dates
- 2 Dec 2020to 15 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- At least 2 years since hamstring muscle repair
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Orthopaedics and Traumatology, University Hospital Basel
Basel, 4031
About this study
Official title: HamRepair: 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.
Read the 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.
- Conditions
- Hamstring Muscle Repair, Hamstring Rupture
- Being tested
- data collection by health questionnaires, assessment of muscle strength, assessment of gait, assessment of squatting and single leg hops, assessment of postural stability
- Keywords
- postoperative muscular imbalances, muscular deficits, pathological gait, Isokinetic muscle strength
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
data collection by health questionnairesOther
Health questionnaires to assess scores concerning pain and function of the treated leg and overall health
assessment of muscle strengthOther
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 gaitOther
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 hopsOther
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 stabilityOther
The length of the centre of pressure path will be measured during two 30-second unipedal stance trials using a force plate.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at baseline (total timeframe for each participant approx 150 minutes)
Secondary outcomes (4)
Range of motion of the knee (degree)
Range of motion of the knee in comparison to the contralateral leg
Measured: 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
Measured: 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
Measured: 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
Measured: at baseline (total timeframe for each participant approx 150 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2021
- Study start2 Dec 2020
- Primary completion15 Apr 2021
- Study completion15 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hamstring Muscle RepairStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karl Stoffel, Prof. Dr. med., Principal investigator, Department of Orthopaedics and Traumatology, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04867746
- Sponsor's protocol ID
- 2020-02276; mu21Stoffel2
- Acronym
- HamRepair
- Status last verified
- Dec 2021
- First submitted
- 27 Apr 2021
- Last updated
- 8 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mauch M, Nuesch C, Buhl L, Chocholac T, Mundermann A, Stoffel K. Reconstruction of proximal hamstring ruptures restores joint biomechanics during various walking conditions. Hip Int. 2024 Jul;34(4):516-523. doi: 10.1177/11207000241230282. Epub 2024 Feb 19.
PubMed 38372148Chocholac T, Buhl L, Nuesch C, Bleichner N, Mundermann A, Stoffel K. Modified surgical anchor refixation in older patients with acute proximal hamstring rupture: clinical outcome, patient satisfaction and muscle strength. Arch Orthop Trauma Surg. 2023 Aug;143(8):4679-4688. doi: 10.1007/s00402-022-04752-3. Epub 2023 Jan 9.
PubMed 36622424
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HamRepair: Clinical and Functional Outcomes at Least 2 Years After Hamstring Muscle Repair
- ClinicalTrials.gov ID
- NCT04867746
- Acronym / sponsor ID
- HamRepair / 2020-02276; mu21Stoffel2
- Conditions
- Hamstring Muscle Repair, Hamstring Rupture
- Keywords
- postoperative muscular imbalances, muscular deficits, pathological gait, Isokinetic muscle strength
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 2 Dec 2020 (actual)
- Primary completion
- 15 Apr 2021 (actual)
- Study completion
- 15 Apr 2021 (actual)
- First posted
- 30 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- At least 2 years since hamstring muscle repair
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| data collection by health questionnairesHealth questionnaires to assess scores concerning pain and function of the treated leg and overall health | Other | – |
| assessment of muscle strengthMuscle 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 gaitInstrumented 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 hopsParticipants 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 stabilityThe length of the centre of pressure path will be measured during two 30-second unipedal stance trials using a force plate. | Other | – |
Primary outcome
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
4 secondary outcomes
Range of motion of the knee (degree)
Time frame: at baseline (total timeframe for each participant approx 150 minutes)
Range of motion of the hip (degree)
Time frame: at baseline (total timeframe for each participant approx 150 minutes)
Joint kinematics (maximum flexion and extension angles)
Time frame: at baseline (total timeframe for each participant approx 150 minutes)
Muscle activity (intensity of the electromyographic signals)
Time frame: at baseline (total timeframe for each participant approx 150 minutes)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2021.
- Derived from this study: PubMed 38372148Mauch M, Nuesch C, Buhl L, Chocholac T, Mundermann A, Stoffel K. Reconstruction of proximal hamstring ruptures restores joint biomechanics during various walking conditions. Hip Int. 2024 Jul;34(4):516-523. doi: 10.1177/11207000241230282. Epub 2024 Feb 19.
- Derived from this study: PubMed 36622424Chocholac T, Buhl L, Nuesch C, Bleichner N, Mundermann A, Stoffel K. Modified surgical anchor refixation in older patients with acute proximal hamstring rupture: clinical outcome, patient satisfaction and muscle strength. Arch Orthop Trauma Surg. 2023 Aug;143(8):4679-4688. doi: 10.1007/s00402-022-04752-3. Epub 2023 Jan 9.
Related trials for Hamstring Muscle Repair
Recruiting
Thermal Therapies in the Treatment of Muscle Injuries
Hamstring Injuries, Hamstring Muscle Repair
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karl Stoffel, Prof. Dr. med. principal investigator
Department of Orthopaedics and Traumatology, University Hospital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hamstring Muscle Repair and Hamstring Rupture, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Isokinetic muscle strength (time frame: at baseline (total timeframe for each participant approx 150 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04867746, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2021; AzTrials last refreshed its copy on 1 Nov 2026.