Femoroacetabular Impingement SyndromeFASTHIPNCT05256628
Early Versus Delayed Weightbearing in Femoroacetabular Impingement Syndrome Patients
A study testing Early Weightbearing and Protected Weightbearing in people with Femoroacetabular Impingement Syndrome, run by Women's College Hospital at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 to 50 years
- Conditions the study is for
- Femoroacetabular Impingement Syndrome
- What is being tested?
- Early Weightbearing and Protected Weightbearing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2022to Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis of femoroacetabular impingement syndrome (FAIS)
- Booked for hip arthroscopy surgery and osteochondroplasty for FAIS at a participating site
- English literate
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Canada1 site
Women's College Hospital
Toronto, Ontario, M5S 1B2
Tim Dwyer, 416-323-6482, tim.dwyer@wchospital.ca
About this study
Official title: 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.
Read the 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.
- Conditions
- Femoroacetabular Impingement Syndrome
- Being tested
- Early Weightbearing, Protected Weightbearing
- Keywords
- Femoroacetabular Impingement, Femoroacetabular Impingement Syndrome, FAI, Hip Arthroscopy, Osteochondroplasty, Orthopaedics, Sports Medicine, Hip, Weight Bearing, Surgery, Arthroscopy
- Medical subject headings
- Femoracetabular Impingement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early WeightbearingOther
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 WeightbearingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Early Weightbearing | Other | Patients randomized to early weightbearing will be permitted to begin immediate postoperative weightbearing as tolerated with crutches for additional stability. Receives: Other: Early Weightbearing |
| Protected Weightbearing | Other | 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. Receives: Other: Protected Weightbearing |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Hip Outcome Tool (iHOT-33)
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.
Measured: Administered at baseline, 6 months, 1 year, and 2 years post-operatively
Secondary outcomes (4)
Hip Outcome Score, Activities of Daily Living (HOS-ADL)
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).
Measured: Administered at baseline, 6 months, 1 year, and 2 years post-operatively
European Quality of Life Five Dimension Five Level (EQ-5D-5L)
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.
Measured: Administered at baseline, 6 months, 1 year, and 2 years post-operatively
Pain Visual Analog Scale (VAS)
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)
Measured: Administered at baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year, and 2 years post-operatively
Post-Operative Complications
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.
Measured: Recorded at 2 weeks, 6 weeks, 3 months, 6 months, 1 year, and 2 years post-operatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study startSep 2022 (estimated)
- Primary completionApr 2024 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (40)Papers the sponsor has linked to this study.
- Other trials for Femoroacetabular Impingement SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women's College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toronto Orthopaedic Sports Medicine
- Responsible party
- Principal investigator, Dr. Tim Dwyer, Women's College Hospital
- Investigators
- Tim Dwyer, Principal investigator, Women's College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05256628
- Sponsor's protocol ID
- 2020-0154-B
- Acronym
- FASTHIP
- Status last verified
- Jul 2022
- First submitted
- 15 Feb 2022
- Last updated
- 15 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Colvin AC, Harrast J, Harner C. Trends in hip arthroscopy. J Bone Joint Surg Am. 2012 Feb 15;94(4):e23. doi: 10.2106/JBJS.J.01886.
PubMed 22336982Bozic KJ, Chan V, Valone FH 3rd, Feeley BT, Vail TP. Trends in hip arthroscopy utilization in the United States. J Arthroplasty. 2013 Sep;28(8 Suppl):140-3. doi: 10.1016/j.arth.2013.02.039. Epub 2013 Aug 1.
PubMed 23916639Montgomery SR, Ngo SS, Hobson T, Nguyen S, Alluri R, Wang JC, Hame SL. Trends and demographics in hip arthroscopy in the United States. Arthroscopy. 2013 Apr;29(4):661-5. doi: 10.1016/j.arthro.2012.11.005. Epub 2013 Feb 1.
PubMed 23375668Ross JR, Larson CM, Bedi A. Indications for Hip Arthroscopy. Sports Health. 2017 Sep/Oct;9(5):402-413. doi: 10.1177/1941738117712675. Epub 2017 Jul 5.
PubMed 28678628Ricciardi BF, Fabricant PD, Fields KG, Poultsides L, Zaltz I, Sink EL. What are the demographic and radiographic characteristics of patients with symptomatic extraarticular femoroacetabular impingement? Clin Orthop Relat Res. 2015 Apr;473(4):1299-308. doi: 10.1007/s11999-014-4001-3.
PubMed 25344401Petrera M, Yanez-Siller F, Whelan D, Hoit G, Mahjoob M, Chahal J, Dwyer T. Analysis of the referral pattern and wait time for hip arthroscopy in a single payer publicly funded health care system. J Eval Clin Pract. 2020 Feb;26(1):81-85. doi: 10.1111/jep.13192. Epub 2019 May 29.
PubMed 31144433Wylie JD, Peters CL, Aoki SK. Natural History of Structural Hip Abnormalities and the Potential for Hip Preservation. J Am Acad Orthop Surg. 2018 Aug 1;26(15):515-525. doi: 10.5435/JAAOS-D-16-00532.
PubMed 29939866McCarthy JC, Lee JA. History of hip arthroscopy: challenges and opportunities. Clin Sports Med. 2011 Apr;30(2):217-24. doi: 10.1016/j.csm.2010.12.001.
PubMed 21419953Collins JA, Ward JP, Youm T. Is prophylactic surgery for femoroacetabular impingement indicated? A systematic review. Am J Sports Med. 2014 Dec;42(12):3009-15. doi: 10.1177/0363546513499227. Epub 2013 Aug 21.
PubMed 23966568Ganz R, Parvizi J, Beck M, Leunig M, Notzli H, Siebenrock KA. Femoroacetabular impingement: a cause for osteoarthritis of the hip. Clin Orthop Relat Res. 2003 Dec;(417):112-20. doi: 10.1097/01.blo.0000096804.78689.c2.
PubMed 14646708Agricola R, Heijboer MP, Bierma-Zeinstra SM, Verhaar JA, Weinans H, Waarsing JH. Cam impingement causes osteoarthritis of the hip: a nationwide prospective cohort study (CHECK). Ann Rheum Dis. 2013 Jun;72(6):918-23. doi: 10.1136/annrheumdis-2012-201643. Epub 2012 Jun 23.
PubMed 22730371Cvetanovich GL, Lizzio V, Meta F, Chan D, Zaltz I, Nho SJ, Makhni EC. Variability and Comprehensiveness of North American Online Available Physical Therapy Protocols Following Hip Arthroscopy for Femoroacetabular Impingement and Labral Repair. Arthroscopy. 2017 Nov;33(11):1998-2005. doi: 10.1016/j.arthro.2017.06.045. Epub 2017 Sep 29.
PubMed 28969949Avnieli IB, Vidra M, Factor S, Atzmon R, Persitz J, Safran N, Rath E, Amar E. Postoperative Weightbearing Protocols After Arthroscopic Surgery for Femoroacetabular Impingement Does Not Affect Patient Outcome: A Comparative Study With Minimum 2-Year Follow-up. Arthroscopy. 2020 Jan;36(1):159-164. doi: 10.1016/j.arthro.2019.08.012.
PubMed 31864571Ayeni OR, Bedi A, Lorich DG, Kelly BT. Femoral neck fracture after arthroscopic management of femoroacetabular impingement: a case report. J Bone Joint Surg Am. 2011 May 4;93(9):e47. doi: 10.2106/JBJS.J.00792. No abstract available.
PubMed 21543668Weber AE, Harris JD, Nho SJ. Complications in Hip Arthroscopy: A Systematic Review and Strategies for Prevention. Sports Med Arthrosc Rev. 2015 Dec;23(4):187-93. doi: 10.1097/JSA.0000000000000084.
PubMed 26524553
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Versus Delayed Weightbearing in FemoroAcetabular Impingement Syndrome Patients Undergoing Treatment With Arthroscopic HIP Osteochondroplasty: a Randomized Controlled Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT05256628
- Acronym / sponsor ID
- FASTHIP / 2020-0154-B
- Conditions
- Femoroacetabular Impingement Syndrome
- Keywords
- Femoroacetabular Impingement, Femoroacetabular Impingement Syndrome, FAI, Hip Arthroscopy, Osteochondroplasty, Orthopaedics, Sports Medicine, Hip
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Women's College HospitalUniversity, hospital or other
- Collaborators
- University of Toronto Orthopaedic Sports Medicine
- Study start
- Sep 2022 (estimated)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 25 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Weightbearing | Other | Other: Early WeightbearingPatients randomized to early weightbearing will be permitted to begin immediate postoperative weightbearing as tolerated with crutches for additional stability. |
| Protected Weightbearing | Other | Other: Protected WeightbearingPatients 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. |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Diagnosis of femoroacetabular impingement syndrome (FAIS)
- Booked for hip arthroscopy surgery and osteochondroplasty for FAIS at a participating site
- English literate
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early WeightbearingPatients 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 | Early Weightbearing |
| Protected WeightbearingPatients 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. | Other | Protected Weightbearing |
Primary outcome
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.
4 secondary outcomes
Hip Outcome Score, Activities of Daily Living (HOS-ADL)
Time frame: 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
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
Post-Operative Complications
Time frame: Recorded at 2 weeks, 6 weeks, 3 months, 6 months, 1 year, and 2 years post-operatively.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2022.
- Background: PubMed 22336982Colvin AC, Harrast J, Harner C. Trends in hip arthroscopy. J Bone Joint Surg Am. 2012 Feb 15;94(4):e23. doi: 10.2106/JBJS.J.01886.
- Background: PubMed 23916639Bozic KJ, Chan V, Valone FH 3rd, Feeley BT, Vail TP. Trends in hip arthroscopy utilization in the United States. J Arthroplasty. 2013 Sep;28(8 Suppl):140-3. doi: 10.1016/j.arth.2013.02.039. Epub 2013 Aug 1.
- Background: PubMed 23375668Montgomery SR, Ngo SS, Hobson T, Nguyen S, Alluri R, Wang JC, Hame SL. Trends and demographics in hip arthroscopy in the United States. Arthroscopy. 2013 Apr;29(4):661-5. doi: 10.1016/j.arthro.2012.11.005. Epub 2013 Feb 1.
- Background: PubMed 28678628Ross JR, Larson CM, Bedi A. Indications for Hip Arthroscopy. Sports Health. 2017 Sep/Oct;9(5):402-413. doi: 10.1177/1941738117712675. Epub 2017 Jul 5.
- Background: PubMed 25344401Ricciardi BF, Fabricant PD, Fields KG, Poultsides L, Zaltz I, Sink EL. What are the demographic and radiographic characteristics of patients with symptomatic extraarticular femoroacetabular impingement? Clin Orthop Relat Res. 2015 Apr;473(4):1299-308. doi: 10.1007/s11999-014-4001-3.
- Background: PubMed 31144433Petrera M, Yanez-Siller F, Whelan D, Hoit G, Mahjoob M, Chahal J, Dwyer T. Analysis of the referral pattern and wait time for hip arthroscopy in a single payer publicly funded health care system. J Eval Clin Pract. 2020 Feb;26(1):81-85. doi: 10.1111/jep.13192. Epub 2019 May 29.
- Background: PubMed 29939866Wylie JD, Peters CL, Aoki SK. Natural History of Structural Hip Abnormalities and the Potential for Hip Preservation. J Am Acad Orthop Surg. 2018 Aug 1;26(15):515-525. doi: 10.5435/JAAOS-D-16-00532.
- Background: PubMed 21419953McCarthy JC, Lee JA. History of hip arthroscopy: challenges and opportunities. Clin Sports Med. 2011 Apr;30(2):217-24. doi: 10.1016/j.csm.2010.12.001.
- Background: PubMed 23966568Collins JA, Ward JP, Youm T. Is prophylactic surgery for femoroacetabular impingement indicated? A systematic review. Am J Sports Med. 2014 Dec;42(12):3009-15. doi: 10.1177/0363546513499227. Epub 2013 Aug 21.
- Background: PubMed 14646708Ganz R, Parvizi J, Beck M, Leunig M, Notzli H, Siebenrock KA. Femoroacetabular impingement: a cause for osteoarthritis of the hip. Clin Orthop Relat Res. 2003 Dec;(417):112-20. doi: 10.1097/01.blo.0000096804.78689.c2.
- Background: PubMed 22730371Agricola R, Heijboer MP, Bierma-Zeinstra SM, Verhaar JA, Weinans H, Waarsing JH. Cam impingement causes osteoarthritis of the hip: a nationwide prospective cohort study (CHECK). Ann Rheum Dis. 2013 Jun;72(6):918-23. doi: 10.1136/annrheumdis-2012-201643. Epub 2012 Jun 23.
- Background: PubMed 28969949Cvetanovich GL, Lizzio V, Meta F, Chan D, Zaltz I, Nho SJ, Makhni EC. Variability and Comprehensiveness of North American Online Available Physical Therapy Protocols Following Hip Arthroscopy for Femoroacetabular Impingement and Labral Repair. Arthroscopy. 2017 Nov;33(11):1998-2005. doi: 10.1016/j.arthro.2017.06.045. Epub 2017 Sep 29.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tim Dwyer principal investigator
Women's College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Weightbearing and Protected Weightbearing in people with Femoroacetabular Impingement Syndrome, run by Women's College Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tim Dwyer (416-323-6482, tim.dwyer@wchospital.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Hip Outcome Tool (iHOT-33) (time frame: Administered at baseline, 6 months, 1 year, and 2 years post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05256628, which also lists 40 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2022.