- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03669471
Muscular and Functional Performance in FAIS Patients
Muscular and Functional Hop Test Performance in Femoroacetabular Impingement Syndrome Patients 6-30 Months Post Hip Arthroscopy - a Cross-sectional Study
Following hip arthroscopy for femoroacetabular impingement syndrome (FAIS) decreased hip muscle strength for adduction, extension, flexion, and external rotation including impaired functional performance have been observed. However, no studies are lacking on more demanding muscular and functional parameters such as hip muscle rate of force development and reactive strength index. Information on such muscular properties following hip arthroscopy for FAIS may help guide future planning of post-operative rehabilitation strategies.
This is a cross-sectional study with an embedded prospective non-randomized study. The aim of the cross-sectional study is to investigate hip muscle function and functional performance in patients who have undergone hip arthroscopy for FAIS during the preceding 6-30 months.
The aim of the prospective non-randomized study is to investigate the effect of a 12-week structured and supervised physiotherapy-led intervention aiming at improving hip muscular function on self-reported hip and groin function including hip muscle function and functional performance.
Forty-five subjects from the Capital Region with an age of 18-40, who have undergone a hip arthroscopy for FAIS during the last 6-30 months, will be included in the cross-sectional study. Additionally, all included subjects will be offered to take part in the prospective non-randomized study consisting of 12 weeks of supervised and structured physiotherapy-led treatment.
The below measures will be obtained at baseline, and at 12-weeks follow-up if subjects are included in the prospective study. All testing, and supervised physiotherapy-led treatment, will be performed at Hvidovre Hospital:
- Hip muscle function
- Single leg jump performance
- Self-reported hip and groin function
- Evaluation of return to sport
- Evaluation of satisfaction regarding usual-care post-operative rehabilitation
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Copenhagen, Denmark
- Testing and exercise-based intervention will be conducted at Hvidovre Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Male/female at the age of 18-40 years at the time of surgery
- Undergone hip arthroscopy for FAIS during the previous 6-30 months (surgical procedure: cam resection and labral surgery)
- Pre-operative cam morphology specified as an alpha angle ≥55°
Exclusion Criteria:
- Pre-surgery joint space width <3 mm
- Any of the following surgical procedures at any time: extra articular surgery of the hip joint (except capsular closure), microfracture, periacetabular osteotomy, and surgery of the ligamentum teres; previous hip arthroscopy in the same hip joint; previous hip pathology such as Perthes' disease, slipped upper femoral epiphysis, hip dysplasia (Lateral Center Edge Angle <25°), and/or avascular necrosis; Any rheumatoid disease in the hip joint such as synovial chondromatosis.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
FAIS group
Subjects who have had a hip arthroscopy for femoroacetabular impingement during the preceding 6-30 months
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The cross-sectional evaluation will involve assessment of:
The exercise-based treatment will involve criteria-based physiotherapy aiming at improving muscle function around the hip and trunk.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Peak force
Time Frame: Baseline (week 0)
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Peak isometric hip torque (Nm/kg) of abduction, adduction, extension, and flexion
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Baseline (week 0)
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Rate of force development
Time Frame: Baseline (week 0)
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0-100 ms and 0-200 ms rate of torque development (Nm/s/kg) of abduction, adduction, extension, and flexion
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Baseline (week 0)
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Self-reported hip and groin function (subjects included in prospective study)
Time Frame: Baseline (week 0) and follow-up (week 12)
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Obtained using the Copenhagen Hip and Groin Outcome Score (HAGOS); Scale from 0 (extreme hip and groin problems) to 100 (no hip and groin problems)
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Baseline (week 0) and follow-up (week 12)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Single leg jump performance
Time Frame: Baseline (week 0)
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Reactive strength index obtained during a single leg drop jump test
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Baseline (week 0)
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Self-reported hip and groin function
Time Frame: Baseline (week 0)
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Obtained using the Copenhagen Hip and Groin Outcome Score (HAGOS); Scale from 0 (extreme hip and groin problems) to 100 (no hip and groin problems)
|
Baseline (week 0)
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Return to sport
Time Frame: Baseline (week 0)
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Obtained using a return to sport questionnaire; Scale: Preinjury sport at preinjury level vs. not preinjury sport at preinjury level.
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Baseline (week 0)
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Satisfaction regarding usual-care post-operative rehabilitation
Time Frame: Baseline (week 0)
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Obtained using a questionnaire; Scale: Satisfied with regular post-operative rehabilitation vs. not satisfied with post-operative rehabilitation.
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Baseline (week 0)
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Change in Peak force (subjects included in prospective study)
Time Frame: Baseline (week 0) and follow-up (week 12)
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Peak isometric hip torque (Nm/kg) of abduction, adduction, extension, and flexion
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Baseline (week 0) and follow-up (week 12)
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Change in rate of force development (subjects included in prospective study)
Time Frame: Baseline (week 0) and follow-up (week 12)
|
0-100 ms and 0-200 ms rate of torque development (Nm/s/kg) of abduction, adduction, extension, and flexion
|
Baseline (week 0) and follow-up (week 12)
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Change in Single leg jump performance (subjects included in prospective study)
Time Frame: Baseline (week 0) and follow-up (week 12)
|
Reactive strength index obtained during a single leg drop jump test
|
Baseline (week 0) and follow-up (week 12)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lasse Ishøi, Sports Orthopedic Research Center - Copenhagen (SORC-C), Ortopædkirurgisk Afdeling, Hvidovre Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FAIS2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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