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

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.

Study Overview

• Status: Completed
• Conditions: Hamstring Muscle Repair; Hamstring Rupture
• Intervention / Treatment: Other: data collection by health questionnaires; Other: assessment of muscle strength; Other: assessment of gait; Other: assessment of squatting and single leg hops; Other: assessment of postural stability

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 Type: Observational
• Enrollment (Actual): 13

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • Department of Orthopaedics and Traumatology, University Hospital Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Range of motion of the knee (degree)	Range of motion of the knee in comparison to the contralateral leg	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	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	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	at baseline (total timeframe for each participant approx 150 minutes)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perth Hamstring Assessment Tool	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.	at baseline (total timeframe for each participant approx 20 minutes)
EQ-5D-5L	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.	at baseline (total timeframe for each participant approx 20 minutes)
Lower Extremity Functional Scale (LEFS)	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.	at baseline (total timeframe for each participant approx 20 minutes)

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Karl Stoffel, Prof. Dr. med., Department of Orthopaedics and Traumatology, University Hospital Basel

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2020
• Primary Completion (Actual): April 15, 2021
• Study Completion (Actual): April 15, 2021

Study Registration Dates

• First Submitted: April 27, 2021
• First Submitted That Met QC Criteria: April 27, 2021
• First Posted (Actual): April 30, 2021

Study Record Updates

• Last Update Posted (Actual): December 8, 2021
• Last Update Submitted That Met QC Criteria: December 7, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Isokinetic muscle strength; postoperative muscular imbalances; muscular deficits; pathological gait
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture
• Other Study ID Numbers: 2020-02276; mu21Stoffel2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No