Weight-Bearing Restrictions After Surgery for FAI

Overseen By Dan Ogborn, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Panam Clinic

Disqualifiers: Previous hip surgery, Chronic pain, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

88 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best recovery methods after hip surgery for femoroacetabular impingement (FAI), a condition where extra bone grows along one or both hip joint bones, causing pain and limited movement. It compares two recovery methods: "Weight-bearing As Tolerated" (WBAT), where patients place as much weight on their leg as feels comfortable immediately after surgery, and "Partial Weight-bearing" (PWB), where they apply only some weight for three weeks. Ideal candidates have experienced hip or groin pain related to movement for at least three months, consulted a doctor, and tried physical therapy without success. As an unphased trial, this study allows patients to contribute to innovative recovery strategies and improve future treatment options.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these weight-bearing protocols are safe after surgery for FAI?

Research has shown that both Partial Weight-bearing (PWB) and Weight-bearing As Tolerated (WBAT) after hip impingement surgery are generally safe. One study found similar rates of side effects for PWB and WBAT, indicating no major safety differences between the two methods.

Patients using WBAT have safely started putting weight on their leg immediately after surgery, with some returning to sports within six months without additional problems. While detailed safety information for PWB is less abundant, studies suggest it is also well-tolerated, as significant side effects have not been reported.

Overall, both treatments are considered safe and have been successfully used in patients following hip impingement surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial comparing weight-bearing protocols after surgery for Femoroacetabular Impingement (FAI) because it seeks to find out how different recovery strategies impact healing and patient outcomes. Traditional post-surgery care often involves strict weight-bearing restrictions for extended periods. However, this trial explores whether allowing patients to bear weight as tolerated immediately after surgery might lead to quicker recovery and better mobility. By comparing this approach to the more conventional partial weight-bearing method, the trial could redefine post-operative care for FAI, potentially offering a faster and more comfortable recovery process for patients.

What evidence suggests that this trial's treatments could be effective for FAI?

This trial will compare two approaches to weight-bearing after surgery for hip impingement (FAI). Research has shown that starting to put weight on the leg as soon as tolerated, known as Weight-bearing As Tolerated (WBAT), is as effective as waiting longer, referred to as Partial Weight-bearing (PWB). One study found that patients who underwent minimally invasive surgery for FAI experienced significant improvements in daily activities and sports participation. Another study suggested that immediate weight-bearing does not lead to worse outcomes compared to waiting. Overall, evidence indicates that early weight-bearing is equally beneficial for recovery as delaying it. ^{1 2 6 7 8}

Who Is on the Research Team?

Devin Lemmex, MD

Principal Investigator

Pan Am Clinic

Are You a Good Fit for This Trial?

This trial is for individuals aged 16-50 with diagnosed femoroacetabular impingement (FAI) who've had unsuccessful non-surgical treatments and can commit to a year of follow-up. It's not for those with chronic pain syndromes, language barriers, previous hip diseases or surgeries, ongoing legal claims related to the hip, severe osteoarthritis or dysplasia.

Inclusion Criteria

I am between 16 and 50 years old.

I was active in sports before surgery and plan to return to sports after.

I have tried physical therapy for 3 months without improvement.

Exclusion Criteria

My hip X-ray shows severe arthritis and abnormal hip shape.

I cannot or do not want to commit to a year of follow-up or testing.

I do not have any infections, significant muscle issues, or other health problems that could affect surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Initial Recovery

Participants undergo arthroscopic surgery for femoroacetabular impingement and begin initial recovery with weight-bearing restrictions

3 weeks

1 visit (in-person)

Rehabilitation

Participants follow either weight-bearing as tolerated (WBAT) or partial weight-bearing (PWB) rehabilitation protocols

up to 12 months

Regular follow-up visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of patient-reported outcomes and functional performance

12 months

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Partial Weight-bearing
• Weight-bearing As Tolerated

Trial Overview The study compares two postoperative strategies after arthroscopic surgery for FAI: 'Weight-bearing As Tolerated' (WBAT) versus 'Partial Weight-bearing' (PWB). Participants will be randomly assigned to one of these approaches and monitored up to 12 months to assess their recovery and return to sports activities.

How Is the Trial Designed?

Group I: Weight-bearing As Tolerated (WBAT) Experimental Treatment 1 Intervention

Patients will WBAT immediately following surgery.

Group II: Partial Weight-bearing (PWB) Active Control 1 Intervention

Patients will PWB for 3 weeks following surgery, followed by a gradual return to FWB.

Who Is Running the Clinical Trial?

Panam Clinic

Lead Sponsor

Trials

17

Recruited

1,500+

Published Research Related to This Trial

In a study involving 32 elderly patients with distal femur fractures, immediate full weight-bearing (FWB) did not show any significant functional advantages over partial weight-bearing (PWB) after 8 weeks, as measured by the short musculoskeletal functional assessment (SMFA).

Both FWB and PWB groups experienced similar rates of adverse events and range of motion, indicating that immediate weight-bearing may be safe, but it does not improve functional outcomes compared to a more cautious approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immediate Full Weight-Bearing Versus Partial Weight-Bearing After Plate Fixation of Distal Femur Fractures in Elderly Patients. A Randomized Controlled Trial. Paulsson, M., Ekholm, C., Jonsson, E., et al.[2022]

In a study of 49 patients recovering from lower extremity surgery, only 37.5% were able to comply with partial or non-weight bearing instructions, indicating a significant challenge in following postoperative care recommendations.

Factors such as age, physical activity level, and body mass index (BMI) influenced compliance, with older patients and those with higher BMI struggling more to adhere to weight-bearing restrictions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of partial weight bearing after surgical treatment in patients with injuries of the lower extremity. Eickhoff, AM., Cintean, R., Fiedler, C., et al.[2022]

Immediate unrestricted weight bearing (UWB) after uncemented total hip arthroplasty (THA) is safe, showing no adverse effects on femoral stem micromotion or increased risks of surgical revision compared to partial weight bearing (PWB).

While UWB did not demonstrate superior outcomes compared to PWB, patients showed a better Harris hip score at one year post-surgery, suggesting that UWB may enhance patient compliance and rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early unrestricted vs. partial weight bearing after uncemented total hip arthroplasty: a systematic review and meta-analysis. Huang, L., Han, W., Qi, W., et al.[2023]

In a study of 50 patients recovering from lower extremity surgery, the ability to partially weight bear was significantly correlated with their age and body weight, indicating these factors may influence recovery.

The Motorische Leistungsserie (MLS) test demonstrated a strong relationship between psychomotor skills and the ability to adhere to prescribed weight limits, suggesting it could be a useful tool for predicting patient outcomes in rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Correlation of psychomotor findings and the ability to partially weight bear. Ruckstuhl, T., Osterhoff, G., Zuffellato, M., et al.[2021]

In a study of 32 elderly patients with distal femur fractures, those who were restricted to partial weight-bearing (PWB) showed significantly less actual weight-bearing and a delayed return to full weight-bearing (FWB) compared to those allowed immediate FWB, indicating that weight-bearing restrictions can hinder recovery.

The PWB group also exhibited a persistently lower walking cadence at 16 and 52 weeks post-surgery, suggesting that even temporary restrictions can have long-term negative effects on gait function, making such restrictions less advisable for recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Temporary Partial Weight-Bearing Restriction in Elderly Patients Treated With a Plate Fixation After a Distal Femur Fracture had a Negative Long-Term Impact on Gait Recovery. Paulsson, M., Ekholm, C., Rolfson, O., et al.[2023]

A multicenter study involving 441 patients with subtrochanteric femur fractures found that allowing weight bearing as tolerated (WBAT) post-surgery significantly reduced the length of hospital stay from 9.7 days to 7.4 days without increasing re-operation rates.

The study suggests that immediate WBAT is safe and effective for patients treated with intramedullary fixation, particularly benefiting those aged 41-80 and with specific fracture characteristics, making it a recommended practice if no contraindications exist.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immediate weight bearing as tolerated (WBAT) correlates with a decreased length of stay post intramedullary fixation for subtrochanteric fractures: a multicenter retrospective cohort study. Cunningham, BP., Ali, A., Parikh, HR., et al.[2021]

A survey of 75 Dutch orthopedic surgeons revealed significant variability in postoperative weight-bearing instructions for patients with periprosthetic femoral fractures (PPFF), indicating a lack of consensus on best practices.

The study highlights the need for further research to establish effective guidelines for permissive weight bearing (PWB) after surgical treatment of PPFF, as current practices differ widely among surgeons.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative Load Bearing in Periprosthetic Femoral Fractures Around Hip Arthroplasty: A Survey Among Orthopedic Surgeons in the Netherlands. Vesseur, MAM., Jelsma, J., Most, J., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10757416/

Postoperative weight-bearing restrictions and rehabilitation ... The reporting of weight-bearing status, clinical outcomes, PROMs and rehabilitation parameters remains poor. At present, sufficient comparative evidence does ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2059775424002098

Clinical outcomes of arthroscopic surgical intervention in ... The results showed that patients who received arthroscopic surgical intervention had a significant improvement of 27.57 and14.79 in HOS-SS and HOS-ADL scores, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6670054/

SHORT-TERM OUTCOMES OF CONSERVATIVE ... Results showed that conservative interventions for short-term periods are effective in reducing pain and improving function for femoroacetabular impingement.

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05280899/weightbearing-restrictions-on-postoperative-outcomes-following-arthroscopic-surgery-for-fai

Weightbearing Restrictions on Postoperative Outcomes ... The purpose of this single-blinded (assessor) randomized trial is to compare patient-reported, clinical and functional outcomes in patients ...

5. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/2325967125S00200

Poster 100: Assessment of an Immediate Weight-Bearing ... In summarizing our initial data, no statistically significant differences were observed in the immediate weight bearing and delayed weight ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12031869/

Comparative outcomes of hip arthroscopy for ... Hip arthroscopy is effective for both football and non-football players with FAI, with both groups experiencing significant improvements in hip joint function ...

7. withpower.com withpower.com/trial/weight-bearing-restrictions-after-surgery-for-fai-a40b2

Weight-Bearing Restrictions After Surgery for FAI Both FWB and PWB groups experienced similar rates of adverse events and range of motion, indicating that immediate weight-bearing may be safe, but it does not ...

8. hca.wa.gov hca.wa.gov/assets/program/fai-final-signals-update-20180212.pdf

Safety and Efficacy of Femoroacetabular Impingement ... After corrective surgery, avoidance of weight bearing for several weeks to months and rehabilitation is required. Surgery to correct FAI ...