Femoro Acetabular ImpingementNCT05280899
Weightbearing Restrictions on Postoperative Outcomes Following Arthroscopic Surgery for FAI
A study testing Weight-bearing As Tolerated and Partial Weight-bearing in people with Femoro Acetabular Impingement, run by Panam Clinic at 1 site in Canada.
Trial summary
The purpose of this single-blinded (assessor) randomized trial is to compare patient-reported, clinical and functional outcomes in patients randomized to weight-bearing as tolerated (WBAT) or partial weight-bearing (PWB) restrictions following arthroscopic surgery for femoroacetabular impingement (FAI) up to 12-months… Read more about this study
- Who is it for?
- Ages 16 to 50 years
- Conditions the study is for
- Femoro Acetabular Impingement
- What is being tested?
- Weight-bearing As Tolerated and Partial Weight-bearing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2022to 1 Apr 2026
- 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
- 16 - 50 years of age at time of surgery
- Diagnosis of FAI (cam, pincer, mixed) based on the 2016 Warwick Agreement. All 3 criteria below must be met:
- Symptoms of motion- or position-related pain in the hip or groin
- Clinical signs consistent with FAI such as: decreased hip flexion and internal rotation, or positive impingement sign
- Radiographic evidence (on BOTH x-ray AND non-contrast MRI) of intra-articular pathology consistent with FAI as determined by the treating surgeon.
- Failed conservative interventions of at least 3 months (i.e. physiotherapy)
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- Have symptom relief with intra-articular injection of local anaesthetic
- Unilateral or bilateral surgical intervention (note: unilateral required to ensure the weight bearing guidelines are followed)
- Are willing to be followed for 12 months post-operative.
- Eligibility for 'return to sport' cohort:
- Additional assessment measures related to return to sport will be collected on the patient who meet the following criteria:
- are or were previously actively involved in sport as indicated by a pre-operative Hip Sports Activity Scale score of four of greater
- indicate a post-operative goal to return to sport following their procedure
Who cannot join
- Clinical:
- Previous surgery on the affected hip, or other major lower extremity orthopaedic surgery
- Active joint or systemic infection, significant muscle paralysis, significant lower extremity or medical comorbidity that could alter the effectiveness of the surgical intervention (e.g. polymyalgia rheumatica)
- Unable to speak or read English/French
- Unable or unwilling to be followed for 1 year or complete functional testing
- Presence of chronic pain syndromes
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- History of pediatric hip disease (i.e. Slipped Capital Femoral Epiphysis, Legg-Calve-Perthes Disease)
- Ongoing litigation or compensation claims related to the hip (including Workers' Compensation)
- Radiographic:
- Osteoarthritis greater than Tönnis Grade 1 on affected hip
- Lateral central edge angle <19°
- Dysplasia in patients with broken Shenton line (i.e. Severe acetabular deformity present)
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Pan Am Clinic
Winnipeg, Manitoba, R3M 3E4
Dan Ogborn, PhD, 204-927-2829, dogborn@panamclinic.com
About this study
Official title: The Impact of Varying Weightbearing Restrictions on Postoperative Outcomes Following Arthroscopic Surgery for Femoroacetabular Impingement: a Randomized Trial
The purpose of this single-blinded (assessor) randomized trial is to compare patient-reported, clinical and functional outcomes in patients randomized to weight-bearing as tolerated (WBAT) or partial weight-bearing (PWB) restrictions following arthroscopic surgery for femoroacetabular impingement (FAI) up to 12-months postoperative.
Read the detailed description
The purpose of this single-blinded (assessor) randomized trial is to compare patient-reported, clinical and functional outcomes in patients randomized to weight-bearing as tolerated (WBAT) or partial weight-bearing (PWB) restrictions following arthroscopic surgery for femoroacetabular impingement (FAI) up to 12-months postoperative. The primary objective is to compare the effects of WBAT or PWB restrictions on PROMS (International Hip Outcome Tool (iHOT33)) and clinical measures following arthroscopic intervention for FAI up to one-year post-operative. The secondary objective will be to assess differences in return to sport (RTS) PROMS, functional performance, and lower extremity kinetics, kinematics, and muscle activity during in patients randomized to either WBAT or PWB at six- and 12-months post-operative. The goal will be to answer if there are differences between a WBAT versus PWB rehabilitation protocol on patient-reported quality of life as measured by the International Hip Outcome Tool (iHOT33) at 12-m post-operative for patients undergoing primary hip arthroscopy for the treatment of FAI.
- Conditions
- Femoro Acetabular Impingement
- Being tested
- Weight-bearing As Tolerated, Partial Weight-bearing
- Medical subject headings
- Femoracetabular Impingement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight-bearing As ToleratedOther
The WBAT group will be instructed to bear weight as tolerated immediately following their surgical procedure. The rehabilitation protocols provided will be identical beyond the initial weightbearing recommendations. Following the initial protection phase (three weeks), whereby the two weightbearing interventions will be provided, patients will progress through standardized phases including mobility and neuromuscular retraining, muscle balance and strengthening, functional training, and finally, advanced training for return to work and sport.
Partial Weight-bearingOther
The PWB group will be instructed to bear weight to a maximum of 20 lbs of bodyweight on the operative limb for the initial three weeks (termed "toe touch"), with graduated return to full weightbearing thereafter.
| Study group | Role | What they receive |
|---|---|---|
| Partial Weight-bearing (PWB) | Active comparator | Patients will PWB for 3 weeks following surgery, followed by a gradual return to FWB. Receives: Other: Partial Weight-bearing |
| Weight-bearing As Tolerated (WBAT) | Experimental | Patients will WBAT immediately following surgery. Receives: Other: Weight-bearing As Tolerated |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Hip Outcome Tool (iHOT-33)
The iHOT uses 33 questions to measure health-related quality of life. It is the primary outcome and has been validated for use in this population. Questions are evaluated on a 100-point visual analog scale (VAS) response format, where "0" represents the worst possible quality of life, and "100" represents the the best.
Measured: 12 months
Secondary outcomes (14)
Non-contrast MRI
Non-contrast MRI will be documented and used to assess for the presence of a labrum tear, articular cartilage lesions, cystic changes within the femoral neck or acetabulum.
Measured: 0 months
Computed Tomography (CT) Scan
All patients will undergo a pre-operative CT scan with three dimensional reconstructions of the hip joint. This permits improved visualization of the boney impingement lesions that are being treated at the time of surgery.
Measured: 0 months
The Copenhagen Hip and Groin Outcome Score (HAGOS)
HAGOS includes six separate subscales assessing pain, symptoms, physical function in daily living, physical function in sport and recreation, participation in physical activity and hip/groin-related quality of life and is designed for use with young to middle-aged physically active individuals with hip pain. Questions are answered on a five-point scale, with "0" indicating no problems, and 4 indicating extreme problems.
Measured: 12 months
Hip Sports Activity Scale (HSAS)
HSAS will indicate the patient's pre surgical and current level of sports participation using a nine-point scale ranging from no recreational or competitive sports ("0") to competitive, elite level sport ("8").
Measured: 12 months
Hip Return to Sport after Injury scale (Hip-RSI)
The Hip-RSI includes six questions regarding an athlete's readiness to return to sport using questions evaluating the athlete's emotional state, their confidence in performance, and their appraisal of risk related to their sport and injury. Each question is graded from 0 to 100, with variable definitions including 0 being "Not confident at all", and 100 being "fully confident", with higher scores indicating higher readiness to return to sport.
Measured: 12 months
Single Assessment Numeric Evaluation (SANE) score
The SANE score is a single question that asks patients to rate their affected hip as a percentage of normal to provide a simple and efficient measure of patient outcome 8. All patients will be asked the following question during their clinical exam: "How would you rate your affected hip today as a percentage of normal (0% to 100% scale with 100% being normal)?"
Measured: 12 months
Rate of surgical complications, re-operations and revision surgeries
Surgical complications will be documented at the time of surgery and at each postoperative interval. A surgical complication is defined as any undesirable, unintended and direct result of an operation affecting the patient that would not have occurred had the operation gone well as could reasonably be hoped (i.e. infection, neurological injury). Revisions and re-operations will be documented, including the reason for failure, date of revision/reoperation, and the procedure performed. A revision is defined as a subsequent surgery performed to correct or compensate for the initial procedure. Re-operation is defined as any surgical procedure other than a revision.
Measured: 12 months
Postoperative Pain and Medication
Postoperative pain will be self-reported on a 100mm visual analogue scale (VAS) in a logbook. Medication type and quantity will also be documented. The Postoperative Pain and Medication Logbook has been previously used by the authors in an ACL population. ) on the scale will represent "No pain at all", and 100 will represent "Wort pain possible".
Measured: 14 days
Hip Isometric Muscle Strength
Isometric hip abduction and extension will be measured in the side-lying and prone positions with a hand-held dynamometer (Chatillon DFX2, Ametek, PA, USA) positioned 5 cm proximal to the most prominent aspect of the malleolus. Four maximal holds of 5 seconds separated by 15 seconds rest will be completed after two submaximal familiarizations with 30 seconds of rest between attempts 25.
Measured: 12 months
Hip Isokinetic Muscle Strength
Five repetitions of concentric, isokinetic hip flexion and extension peak torque will be measured on an isokinetic dynamometer (Biodex, Medical System 3, NY, USA) with the patient in the supine position (0 degrees to 50 degrees hip flexion at 60 degrees/second). Hamstring strength will be measured with the NordBord Hamstring Dynamometer (Vald, Qld, Aus).
Measured: 12 months
Jump Testing
Participants will complete a standardized battery consisting of the drop vertical jump (jumping from a 30cm box to force plates positioned at a distance of 50% of their height from the starting line), a counter movement jump (jumping from the standing position with the hands on the hips on dual force plates), a squat jump and a single leg countermovement jump. Jump attempts will be recorded with three cameras (one frontal, two sagittal plane views) to assess maximal joint angles of the ankle, knee and hip. Anatomical markers for kinematic analysis of the lower extremity will be placed bilaterally at the following sites: anterior superior iliac spine, lateral iliac crest, greater trochanter, mid-thigh, medial and lateral knee joint line, tibial tubercle, mid-shank, distal shank, medial and lateral malleolus, and to the foot at the heel, dorsal surface of the lateral mid-foot, and toe with adhesive tape to the shoes
Measured: 12 months
Hop Tests
A standardized battery of hop tests will be completed including the single leg hop, triple hop, triple crossover hop and medial and lateral triple hops for distance. Distances will be measured from the starting line to the posterior surface of the heel at landing with a standard tape measure
Measured: 12 months
5-0-5 Change of Direction (505)
The participant will run 15 m, complete an 180o change of direction and run back to the starting line, with timing gates positioned at the 10 m mark to time the direction change (Brower Timing Systems, UT, USA).
Measured: 12 months
Electromyography of the gluteal muscles
Electromyographic (EMG) data will be collected per Surface Electromyography for the Non-Invasive Assessment of Muscles (SENIAM) standards on the upper and lower portions of the gluteus maximus muscle group (two finger widths above and below the midline between the posterior superior iliac spine and the greater trochanter of the femur for the upper and lower gluteus maximum respectively) and gluteus medius (proximal 1/3 of the distance between the iliac crest and the greater trochanter) following preparation of the skin (shaving and cleaning of the skin with isopropyl alcohol). Prior to testing, maximal voluntary isometric contractions of the gluteal muscles will be completed for normalization purposes. Peak EMG amplitudes for the gluteal muscles normalized to maximal voluntary isometric contractions will be collected during isometric hip abduction and extension and isokinetic hip flexion and extension and compared between the affected and unaffected limb, and between treatment groups
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start1 Sep 2022
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoro Acetabular ImpingementStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized, single-blinded trial will be completed with patients receiving one of two differing post-operative weightbearing recommendations
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Panam Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Devin Lemmex, MD, Principal investigator, Pan Am Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05280899
- Sponsor's protocol ID
- Hip WB RCT
- Status last verified
- Apr 2024
- First submitted
- 14 Dec 2021
- Last updated
- 2 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Varying Weightbearing Restrictions on Postoperative Outcomes Following Arthroscopic Surgery for Femoroacetabular Impingement: a Randomized Trial
- ClinicalTrials.gov ID
- NCT05280899
- Acronym / sponsor ID
- Hip WB RCT
- Conditions
- Femoro Acetabular Impingement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Panam ClinicUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 15 Mar 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.
The purpose of this single-blinded (assessor) randomized trial is to compare patient-reported, clinical and functional outcomes in patients randomized to weight-bearing as tolerated (WBAT) or partial weight-bearing (PWB) restrictions following arthroscopic surgery for femoroacetabular impingement (FAI) up to 12-months postoperative.
Detailed description
The purpose of this single-blinded (assessor) randomized trial is to compare patient-reported, clinical and functional outcomes in patients randomized to weight-bearing as tolerated (WBAT) or partial weight-bearing (PWB) restrictions following arthroscopic surgery for femoroacetabular impingement (FAI) up to 12-months postoperative. The primary objective is to compare the effects of WBAT or PWB restrictions on PROMS (International Hip Outcome Tool (iHOT33)) and clinical measures following arthroscopic intervention for FAI up to one-year post-operative. The secondary objective will be to assess differences in return to sport (RTS) PROMS, functional performance, and lower extremity kinetics, kinematics, and muscle activity during in patients randomized to either WBAT or PWB at six- and 12-months post-operative. The goal will be to answer if there are differences between a WBAT versus PWB rehabilitation protocol on patient-reported quality of life as measured by the International Hip Outcome Tool (iHOT33) at 12-m post-operative for patients undergoing primary hip arthroscopy for the treatment of FAI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized, single-blinded trial will be completed with patients receiving one of two differing post-operative weightbearing recommendations
| Arm | Type | Receives |
|---|---|---|
| Partial Weight-bearing (PWB) | Active comparator | Other: Partial Weight-bearingPatients will PWB for 3 weeks following surgery, followed by a gradual return to FWB. |
| Weight-bearing As Tolerated (WBAT) | Experimental | Other: Weight-bearing As ToleratedPatients will WBAT immediately following surgery. |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (13 listed)
- 16 - 50 years of age at time of surgery
- Diagnosis of FAI (cam, pincer, mixed) based on the 2016 Warwick Agreement. All 3 criteria below must be met:
- Failed conservative interventions of at least 3 months (i.e. physiotherapy)
- Have symptom relief with intra-articular injection of local anaesthetic
- Unilateral or bilateral surgical intervention (note: unilateral required to ensure the weight bearing guidelines are followed)
Key exclusion criteria (12 listed)
- Previous surgery on the affected hip, or other major lower extremity orthopaedic surgery
- Active joint or systemic infection, significant muscle paralysis, significant lower extremity or medical comorbidity that could alter the effectiveness of the surgical intervention (e.g. polymyalgia rheumatica)
- Unable to speak or read English/French
- Unable or unwilling to be followed for 1 year or complete functional testing
- Presence of chronic pain syndromes
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 |
|---|---|---|
| Weight-bearing As ToleratedThe WBAT group will be instructed to bear weight as tolerated immediately following their surgical procedure. The rehabilitation protocols provided will be identical beyond the initial weightbearing recommendations. Following the initial protection phase (three weeks), whereby the two weightbearing interventions will be provided, patients will progress through standardized phases including mobility and neuromuscular retraining, muscle balance and strengthening, functional training, and finally, advanced training for return to work and sport. | Other | Weight-bearing As Tolerated (WBAT) |
| Partial Weight-bearingThe PWB group will be instructed to bear weight to a maximum of 20 lbs of bodyweight on the operative limb for the initial three weeks (termed "toe touch"), with graduated return to full weightbearing thereafter. | Other | Partial Weight-bearing (PWB) |
Primary outcome
International Hip Outcome Tool (iHOT-33)
Time frame: 12 months
The iHOT uses 33 questions to measure health-related quality of life. It is the primary outcome and has been validated for use in this population. Questions are evaluated on a 100-point visual analog scale (VAS) response format, where "0" represents the worst possible quality of life, and "100" represents the the best.
14 secondary outcomes
Non-contrast MRI
Time frame: 0 months
Computed Tomography (CT) Scan
Time frame: 0 months
The Copenhagen Hip and Groin Outcome Score (HAGOS)
Time frame: 12 months
Hip Sports Activity Scale (HSAS)
Time frame: 12 months
Hip Return to Sport after Injury scale (Hip-RSI)
Time frame: 12 months
Single Assessment Numeric Evaluation (SANE) score
Time frame: 12 months
Rate of surgical complications, re-operations and revision surgeries
Time frame: 12 months
Postoperative Pain and Medication
Time frame: 14 days
Hip Isometric Muscle Strength
Time frame: 12 months
Hip Isokinetic Muscle Strength
Time frame: 12 months
Jump Testing
Time frame: 12 months
Hop Tests
Time frame: 12 months
5-0-5 Change of Direction (505)
Time frame: 12 months
Electromyography of the gluteal muscles
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- 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.
Devin Lemmex, MD principal investigator
Pan Am Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight-bearing As Tolerated and Partial Weight-bearing in people with Femoro Acetabular Impingement, run by Panam Clinic 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 13 inclusion and 12 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 2 Apr 2024. 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 Dan Ogborn, PhD (204-927-2829, dogborn@panamclinic.com), 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: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Apr 2024.