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Efficacy of an Exercise Program for Patients With Femoro-acetabular Impingement

Primary Purpose

Femoracetabular Impingement

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Exercise Group
Sponsored by
Ottawa Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Femoracetabular Impingement focused on measuring non-surgical treatment, exercise

Eligibility Criteria

16 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosed with symptomatic FAI
  • at least 3 months of groin pain
  • increased pain with hip rotation
  • an alpha angle greater than 60 degrees on multiplane imaging
  • labral tear on MRI
  • Tonnis grade of 0 or 1

Exclusion Criteria:

  • diagnosed health problems other than FAI interfering with capacity to accomplish the exercise program
  • previous hip surgery on the affected side
  • surgery will happen within 6 months

Sites / Locations

  • The Ottawa HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise Group

Control Group

Arm Description

The group who will exercise to manage pain.

The group who will not take part in any exercises and only have to do assessments.

Outcomes

Primary Outcome Measures

iHOT-33
International Hip Outcome Tool-33, disease-specific function. Each answer will be measured on a scale of 100mm and the mean of the 33 questions will be taken as a final score. A higher score indicates a better quality of life.

Secondary Outcome Measures

EQ-5D-5L
Generic quality of life, the scores for each question are summed up for a total with a higher score being a better quality of life.
Pelvic and hip biomechanics (Femoral head displacement)
Displacement of the femoral head center from the neutral position (measured in degrees)
Pelvic and hip biomechanics (Coverage of femoral head)
Coverage of the femoral head provided by the acetabular margin (measured in degrees)
Pelvic and hip biomechanics (Acetabular rim and femoral neck distance)
the closest distance between the acetabular rim and the femoral neck (measured in mm)
Number of participants that receive hip surgery
If the participant has hip surgery in the time frame

Full Information

First Posted
April 14, 2019
Last Updated
June 22, 2021
Sponsor
Ottawa Hospital Research Institute
Collaborators
Canadian Orthopaedic Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03949127
Brief Title
Efficacy of an Exercise Program for Patients With Femoro-acetabular Impingement
Official Title
Efficacy of a Non-surgical Treatment Protocol for Patients With Symptomatic Femoro-acetabular Impingement: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 6, 2019 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Hospital Research Institute
Collaborators
Canadian Orthopaedic Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to examine whether using an exercise regime on people with femoroacetabular impingement (FAI) can help reduce pain and improve function. Also, it examines whether the exercise regime will help prevent the worsening of hip cartilage deterioration.
Detailed Description
A significant proportion of adults from ages 18 to 50 have a deformity in the neck of their femur. This can be painful and is called a femoroacetabular impingement (FAI), and could lead to ones cartilage being destroyed and possibly lead to osteoarthritis of the hip. People with this deformity in their femur have been found to move their hips differently when doing tasks such as walking, squatting or climbing stairs compared to those without this problem. The investigators are testing whether exercise that targets this difference in movement can help reduce pain, improve function and prevent cartilage damage. There will recruit 84 patients with divided into 2 groups. 42 patients will do a 8 week exercise program on strengthening muscles responsible for extending the hip and stretching muscles that are associated with flexing the hip. The intensity of the program will change with visits to the physiotherapist through the course of their exercise program. This research hopes to develop an innovative, non-surgical, low-cost, highly feasible and accessible intervention for patients with FAI.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoracetabular Impingement
Keywords
non-surgical treatment, exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
There will be two groups, one will be the exercise group and one will be used as a control group.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise Group
Arm Type
Experimental
Arm Description
The group who will exercise to manage pain.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The group who will not take part in any exercises and only have to do assessments.
Intervention Type
Other
Intervention Name(s)
Exercise Group
Intervention Description
The group who will meet a physiotherapist who will show them strengthening and stretching muscles associated with pelvic tilt.
Primary Outcome Measure Information:
Title
iHOT-33
Description
International Hip Outcome Tool-33, disease-specific function. Each answer will be measured on a scale of 100mm and the mean of the 33 questions will be taken as a final score. A higher score indicates a better quality of life.
Time Frame
Change in Baseline before exercise program and 1 year afterwards
Secondary Outcome Measure Information:
Title
EQ-5D-5L
Description
Generic quality of life, the scores for each question are summed up for a total with a higher score being a better quality of life.
Time Frame
Change in Baseline before exercise program and 1 year afterwards
Title
Pelvic and hip biomechanics (Femoral head displacement)
Description
Displacement of the femoral head center from the neutral position (measured in degrees)
Time Frame
Change in Baseline before exercise program and 1 year afterwards
Title
Pelvic and hip biomechanics (Coverage of femoral head)
Description
Coverage of the femoral head provided by the acetabular margin (measured in degrees)
Time Frame
Change in Baseline before exercise program and 1 year afterwards
Title
Pelvic and hip biomechanics (Acetabular rim and femoral neck distance)
Description
the closest distance between the acetabular rim and the femoral neck (measured in mm)
Time Frame
Change in Baseline before exercise program and 1 year afterwards
Title
Number of participants that receive hip surgery
Description
If the participant has hip surgery in the time frame
Time Frame
Change in Baseline before exercise program and 1 year afterwards

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed with symptomatic FAI at least 3 months of groin pain increased pain with hip rotation an alpha angle greater than 60 degrees on multiplane imaging labral tear on MRI Tonnis grade of 0 or 1 Exclusion Criteria: diagnosed health problems other than FAI interfering with capacity to accomplish the exercise program previous hip surgery on the affected side surgery will happen within 6 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lissa Pacheco, PhD (c)
Phone
613-737-8920
Email
lipacheco@ohri.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Beaule, MD, FRCSC
Organizational Affiliation
Ottawa Hospital Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Beaule, MD, FRCSC

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Efficacy of an Exercise Program for Patients With Femoro-acetabular Impingement

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