Muscular and Functional Performance in FAIS Patients

December 15, 2019 updated by: Lasse Ishøi, Hvidovre University Hospital

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:

  1. Hip muscle function
  2. Single leg jump performance
  3. Self-reported hip and groin function
  4. Evaluation of return to sport
  5. Evaluation of satisfaction regarding usual-care post-operative rehabilitation

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Copenhagen, Denmark
        • Testing and exercise-based intervention will be conducted at Hvidovre Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects who have undergone hip arthroscopy for femoroacetabular impingement syndrome during the preceding 6-30 months in the Greater Copehangen Area

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

The cross-sectional evaluation will involve assessment of:

  1. Hip muscle function
  2. Single leg jump performance
  3. Self-reported hip and groin function
  4. Evaluation of return to sport
  5. Evaluation of satisfaction regarding usual-care post-operative rehabilitation

The exercise-based treatment will involve criteria-based physiotherapy aiming at improving muscle function around the hip and trunk.

Other Names:
  • Exercise-based treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak force
Time Frame: Baseline (week 0)
Peak isometric hip torque (Nm/kg) of abduction, adduction, extension, and flexion
Baseline (week 0)
Rate of force development
Time Frame: Baseline (week 0)
0-100 ms and 0-200 ms rate of torque development (Nm/s/kg) of abduction, adduction, extension, and flexion
Baseline (week 0)
Self-reported hip and groin function (subjects included in prospective study)
Time Frame: Baseline (week 0) and follow-up (week 12)
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) and follow-up (week 12)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Single leg jump performance
Time Frame: Baseline (week 0)
Reactive strength index obtained during a single leg drop jump test
Baseline (week 0)
Self-reported hip and groin function
Time Frame: Baseline (week 0)
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)
Return to sport
Time Frame: Baseline (week 0)
Obtained using a return to sport questionnaire; Scale: Preinjury sport at preinjury level vs. not preinjury sport at preinjury level.
Baseline (week 0)
Satisfaction regarding usual-care post-operative rehabilitation
Time Frame: Baseline (week 0)
Obtained using a questionnaire; Scale: Satisfied with regular post-operative rehabilitation vs. not satisfied with post-operative rehabilitation.
Baseline (week 0)
Change in Peak force (subjects included in prospective study)
Time Frame: Baseline (week 0) and follow-up (week 12)
Peak isometric hip torque (Nm/kg) of abduction, adduction, extension, and flexion
Baseline (week 0) and follow-up (week 12)
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)
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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Lasse Ishøi, Sports Orthopedic Research Center - Copenhagen (SORC-C), Ortopædkirurgisk Afdeling, Hvidovre Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 13, 2018

Primary Completion (Actual)

September 10, 2019

Study Completion (Actual)

December 15, 2019

Study Registration Dates

First Submitted

September 7, 2018

First Submitted That Met QC Criteria

September 11, 2018

First Posted (Actual)

September 13, 2018

Study Record Updates

Last Update Posted (Actual)

December 17, 2019

Last Update Submitted That Met QC Criteria

December 15, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • FAIS2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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