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

NCT ID: NCT04867746

Last Updated: 2021-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

13 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-02

Study Completion Date

2021-04-15

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.

Conditions

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Hamstring Muscle Repair Hamstring Rupture

Keywords

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postoperative muscular imbalances muscular deficits pathological gait Isokinetic muscle strength

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Interventions

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data collection by health questionnaires

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

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Karl Stoffel, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Department of Orthopaedics and Traumatology, University Hospital Basel

Locations

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Department of Orthopaedics and Traumatology, University Hospital Basel

Basel, , Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type DERIVED
PMID: 38372148 (View on PubMed)

Chocholac 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.

Reference Type DERIVED
PMID: 36622424 (View on PubMed)

Other Identifiers

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2020-02276; mu21Stoffel2

Identifier Type: -

Identifier Source: org_study_id