Early Versus Delayed Weightbearing in Femoroacetabular Impingement Syndrome Patients
NCT ID: NCT05256628
Last Updated: 2022-07-15
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
240 participants
Study Classification
INTERVENTIONAL
Study Start Date
2022-09-30
Study Completion Date
2024-04-30
Brief Summary
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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.
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.
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Detailed Description
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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.
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.
Conditions
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Femoroacetabular Impingement Syndrome
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
SUPPORTIVE_CARE
Blinding Strategy
SINGLE
Outcome Assessors
Neither the patient nor their surgeon will be blinded. However, outcome assessors will be blinded throughout the duration of the study. Assessors will screen for complications at follow-up visits.
Study Groups
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Early Weightbearing
Patients randomized to early weightbearing will be permitted to begin immediate postoperative weightbearing as tolerated with crutches for additional stability.
Group Type
OTHER
Early Weightbearing
Intervention Type
OTHER
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.
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.
Group Type
OTHER
Protected Weightbearing
Intervention Type
OTHER
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.
Interventions
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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.
Intervention Type
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.
Intervention Type
OTHER
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of femoroacetabular impingement syndrome (FAIS)
* Booked for hip arthroscopy surgery and osteochondroplasty for FAIS at a participating site
* English literate
* 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)
* 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)
Minimum Eligible Age
16 Years
Maximum Eligible Age
50 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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University of Toronto Orthopaedic Sports Medicine
OTHER
Sponsor Role
collaborator
Women's College Hospital
OTHER
Sponsor Role
lead
Responsible Party
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Dr. Tim Dwyer
Dr. Tim Dwyer, Orthopaedic Surgeon, Principal Investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Tim Dwyer
Role: PRINCIPAL_INVESTIGATOR
Women's College Hospital
Locations
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Women's College Hospital
Toronto, Ontario, Canada
Site Status
Countries
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Canada
Central Contacts
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Facility Contacts
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References
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Other Identifiers
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2020-0154-B
Identifier Type: -
Identifier Source: org_study_id
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