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

NCT04867746 | Completed

• 1 other identifier: 2020-02276; mu21Stoffel2
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Hamstring Muscle Repair; Hamstring Rupture

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

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

Secondary Outcomes (4)

• Range of motion of the knee (degree)

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

• Range of motion of the hip (degree)

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

• Joint kinematics (maximum flexion and extension angles)

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

• Muscle activity (intensity of the electromyographic signals)

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

Other Outcomes (3)

• Perth Hamstring Assessment Tool

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

• EQ-5D-5L

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

• Lower Extremity Functional Scale (LEFS)

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

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• At least 2 years since hamstring muscle repair

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Department of Orthopaedics and Traumatology, University Hospital Basel

Basel, 4031, Switzerland

Location

Related Publications (2)

• 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.

  PMID: 38372148 DERIVED

• 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.

  PMID: 36622424 DERIVED

Study Officials

• Karl Stoffel, Prof. Dr. med.

  Department of Orthopaedics and Traumatology, University Hospital Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: April 30, 2021
• Study Start: December 2, 2020
• Primary Completion: April 15, 2021
• Study Completion: April 15, 2021
• Last Updated: December 8, 2021

Record last verified: 2021-12

Locations

CH (1)