Early Versus Delayed Weightbearing in Femoroacetabular Impingement Syndrome Patients (FASTHIP)

July 14, 2022 updated by: Dr. Tim Dwyer, Women's College Hospital

Early Versus Delayed Weightbearing in FemoroAcetabular Impingement Syndrome Patients Undergoing Treatment With Arthroscopic HIP Osteochondroplasty: a Randomized Controlled Non-inferiority Trial

Femoroacetabular impingement syndrome (FAIS) is a condition caused by an abnormal bone structure that causes the bones on either side of the hip joint to impinge on each other during certain movements, thus causing pain. This condition can be surgically treated with hip arthroscopy. For patients undergoing hip arthroscopy, there are currently two protocols related to how they may bear their weight after surgery: 1) Delayed Weightbearing: Patients use crutches and put very little weight on the surgical side. After 6 weeks, they are able to bear weight, 2) Immediate Weightbearing: Patients bear weight on the affected side, as tolerated, immediately after surgery with crutches for additional support. They are then permitted to stop using the crutches in the weeks after surgery as they feel comfortable and are stable on the operative leg.

The purpose of this study is to determine whether immediate or delayed weightbearing protocols following hip arthroscopy impact patient outcomes and complication rates. Participants will be randomly allocated into one of the two aforementioned groups, and followed up for 2 years to assess function and patient-reported outcomes.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Hip arthroscopy is used in the surgical treatment of femoroacetabular impingement syndrome (FAIS). There remains debate as to whether patients should be restricted to touch weightbearing post-operatively to prevent complications and improve clinical outcomes. This study aims to assess whether early weightbearing will produce non-inferior patient reported outcomes compared to protected touch weightbearing at 1 year post-operatively. We hypothesize that patients who are allowed to bear weight immediately after surgery will have non-inferior outcomes in comparison to those allowed to bear weight at 6 weeks post-operatively.

The FASTHIP trial is a multi-center, non-inferiority randomized controlled trial, looking at patients who are 16-50 years old, undergoing hip arthroscopy and osteochondroplasty for femoroacetabular impingement syndrome. All patients will be under general anesthesia, supine on a traction table. They will then undergo hip arthroscopy and associated procedures according to their respective surgeon's typical practice. This will result in different surgical techniques being represented in this study, with variances in portal placement, bone resection strategy, labral repair strategy and capsular closure technique. This is meant to reflect the true practice variances among hip arthroscopists and is inherent in the pragmatic nature of the trial. Participants will be randomized into one of two groups (immediate weightbearing as tolerated vs. touch weightbearing for 6 weeks following hip arthroscopy) in a 1:1 fashion using a computer-generated randomization schedule. Following surgery, all participants will receive a post-operative prescription of acetaminophen for three days, followed by Celebrex daily, and a conservative number of opioids for pain control. All participants will also receive standardized physiotherapy instructions outlining a phased approach from early joint protection and range of motion, to strengthening and sport specific goals in subsequent months. Initially, patients will be restricted to: hip extension 0, flexion 90, abduction 0, adduction 30 and limited external, internal rotation. At 6 weeks patients progress to full ROM and strengthening exercises. Return to sport targets instructions will be patient and sport specific, but generally recommended at 6 months.

Following screening, consent, collection of baseline data, and surgery, patients will be seen post-operatively at 2-weeks, 6-weeks, 3-months, 6-months, 1-year, and 2-years. Patient reported outcomes will be collected at 6 weeks, 3 months, 6-months, 1-year and 2-year appointments.

Study Type

Interventional

Enrollment (Anticipated)

240

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5S 1B2

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

16 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of femoroacetabular impingement syndrome (FAIS)
  • Booked for hip arthroscopy surgery and osteochondroplasty for FAIS at a participating site
  • English literate

Exclusion Criteria:

  • Prior hip surgery, arthroscopic or otherwise
  • Workplace Safety and Insurance Board/medicolegal claim, complex regional pain syndrome, fibromyalgia, pain syndrome diagnoses, regular opioid use beyond 50mg morphine equivalents per day
  • Hip dysplasia, Legg-Calve-Perthes disease or slipped capital femoral epiphysis, Arthritis > Tonnis 1
  • Chondral matrix repair, microfracture/osteoarticular transfer system (OATS)

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

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Early Weightbearing
Patients randomized to early weightbearing will be permitted to begin immediate postoperative weightbearing as tolerated with crutches for additional stability.
Other: Early Weightbearing
Patients randomized to undergo this study intervention will bear weight, as tolerated, on the affected side straight after surgery, with crutches for additional support and stability. They will be allowed to stop using crutches in the weeks after surgery as they feel more comfortable and stable on their surgical leg.
Other: Protected Weightbearing
Patients in the protected weightbearing group will be instructed to be touch weightbearing for a period of 6-weeks postoperatively before commencing to be weightbearing as tolerated.
Other: Protected Weightbearing
Patients randomized to undergo this study intervention will be instructed to be touch weightbearing for 6 weeks after surgery. They will use crutches and put no more weight on the surgical side than what it takes to crack an egg. After the 6-week mark, they will be able to bear weight.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
International Hip Outcome Tool (iHOT-33)
Time Frame: Administered at baseline, 6 months, 1 year, and 2 years post-operatively

The primary outcome is the difference between the two interventions in their iHOT-33 scores at 1 year post-surgery.

The iHOT-33 questionnaire consists of 33 questions evaluating hip symptoms, functional impairments, sporting activities, job concerns, as well as social and emotional wellbeing. Participants will rate their pain and impairment levels on a scale of 0 to 10, 0 being severe pain/impairment, and 10 being no pain or trouble at all.
Administered at baseline, 6 months, 1 year, and 2 years post-operatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hip Outcome Score, Activities of Daily Living (HOS-ADL)
Time Frame: Administered at baseline, 6 months, 1 year, and 2 years post-operatively
The HOS-ADL consists of 17 questions that assess the impact of hip conditions on activities of daily living. Patients are asked to rate the level of difficulty in performing 17 different tasks, on a scale of 0 (unable to perform) to 4 (no difficulty at all).
Administered at baseline, 6 months, 1 year, and 2 years post-operatively
European Quality of Life Five Dimension Five Level (EQ-5D-5L)
Time Frame: Administered at baseline, 6 months, 1 year, and 2 years post-operatively
The EQ-5D-5L assesses patients' overall quality of life and health. This measure asks questions related to mobility, self-care, activity, pain, and anxiety/depression. The measure also includes one 0-100 scale assessing how patients perceive their overall health.
Administered at baseline, 6 months, 1 year, and 2 years post-operatively
Pain Visual Analog Scale (VAS)
Time Frame: Administered at baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year, and 2 years post-operatively
Participants will indicate their level of pain on a 10cm line that represents a spectrum ranging from no pain (left side), to severe pain (right side)
Administered at baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year, and 2 years post-operatively
Post-Operative Complications
Time Frame: Recorded at 2 weeks, 6 weeks, 3 months, 6 months, 1 year, and 2 years post-operatively.
Incidences of complications such as infection, deep vein thrombosis, restrictions in ROM, adhesive capsulitis, fractures, prolonged opioid use, and early reoperation will be collected and recorded.
Recorded at 2 weeks, 6 weeks, 3 months, 6 months, 1 year, and 2 years post-operatively.

Collaborators and Investigators

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

Sponsor

Women's College Hospital

Collaborators

University of Toronto Orthopaedic Sports Medicine

Investigators

  • Principal Investigator: Tim Dwyer, Women's College Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Anticipated)

September 1, 2022

Primary Completion (Anticipated)

April 1, 2024

Study Completion (Anticipated)

April 1, 2024

Study Registration Dates

First Submitted

February 15, 2022

First Submitted That Met QC Criteria

February 15, 2022

First Posted (Actual)

February 25, 2022

Study Record Updates

Last Update Posted (Actual)

July 15, 2022

Last Update Submitted That Met QC Criteria

July 14, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-0154-B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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