Labral Repair vs Reconstruction for Femoroacetabular Impingement

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two surgical options for individuals with hip pain due to femoroacetabular impingement syndrome (FAIS), a condition where extra bone grows along one or both bones forming the hip joint. The study compares labral repair, which involves sewing damaged cartilage back together, and labral reconstruction, where donor tissue replaces the cartilage. Researchers aim to determine which method provides better outcomes for patients over 40 undergoing hip surgery. This trial may suit those with hip pain from FAIS that hasn't improved with other treatments. As an unphased study, it offers a unique opportunity to contribute to understanding which surgical option might be more beneficial for similar patients.

Do I have to stop taking my current medications for the trial?

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Past studies have shown that both labral reconstruction and labral repair for hip problems are safe. Research indicates that labral reconstruction yields excellent patient-reported outcomes with few complications. For example, athletes have reported positive experiences and minimal issues at least one year post-surgery.

Similarly, studies on labral repair demonstrate that it is generally well-tolerated and improves hip function over time. Long-term results suggest it helps maintain hip health. Although both treatments involve surgery, they are safe, with most patients experiencing improved hip function and reduced pain.12345

Why are researchers excited about this trial?

Researchers are excited about these treatments because they offer different approaches to addressing femoroacetabular impingement. Labral Reconstruction is unique because it uses an allograft to reconstruct the labrum, potentially offering a more durable solution for severely damaged labral tissue. On the other hand, Labral Repair involves using suture anchors to repair the existing labrum, which may preserve more of the patient's original tissue and promote natural healing. Unlike the standard of care that often focuses on symptom management, these techniques aim to restore hip function more effectively by directly addressing labral damage.

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

This trial will compare labral repair with labral reconstruction for treating femoroacetabular impingement syndrome (FAIS). Studies have shown that both procedures can improve hip function and reduce pain in people with FAIS. Research indicates that labral repair often results in better patient-reported outcomes, significantly enhancing their ability to perform daily activities. Labral reconstruction also demonstrates promising results, with over 90% of joints remaining healthy after ten years. Both treatments achieve high satisfaction rates and lead to long-term improvements in hip function. Overall, these procedures effectively address hip issues related to FAIS, each offering distinct benefits.12367

Are You a Good Fit for This Trial?

This trial is for people over 40 years old who need hip arthroscopy due to femoroacetabular impingement (FAI).

Inclusion Criteria

I have hip bone shape issues and did not improve with non-surgical treatments.

Exclusion Criteria

I have significant muscle paralysis.
I currently have an active infection in my joints or body.
I am not willing to be monitored for 2 years.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo hip arthroscopy with either labral repair or reconstruction

6-8 weeks
Multiple visits for surgery and post-operative care

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months
Regular follow-up visits to assess outcomes

What Are the Treatments Tested in This Trial?

Interventions

  • Labral Reconstruction
  • Labral Repair

Trial Overview

The study compares two surgical techniques—labral repair and labral reconstruction—for treating hip problems caused by FAI. Participants are randomly assigned to one of the two procedures.

How Is the Trial Designed?

2

Treatment groups

Active Control

Group I: Labral ReconstructionActive Control1 Intervention
Group II: Labral RepairActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Western University, Canada

Lead Sponsor

Trials
270
Recruited
62,500+

Citations

Ten-year outcome following surgical treatment of ... - PMC - NIH

- Femoroacetabular impingement (FAI) surgery provides a lasting improvement in functional scores and an acceptable joint preservation rate of 90.4% at ten years ...

Labral Repair vs. Reconstruction in Hip Arthroscopy

Positive Outcomes: Labral repair resulted in better patient-reported outcomes, with significant improvements in daily activity scores (HOS-ADL) ...

Two-Year Outcomes of Primary Arthroscopic Surgery in ...

The purpose of this study was to compare the minimum 2-year patient-reported outcomes (PROs) and risk of revision or conversion to arthroplasty between primary ...

Outcomes and complications of hip arthroscopy for ...

Hip arthroscopy has emerged as the primary surgical intervention for Femoroacetabular Impingement Syndrome (FAIS), a common cause of hip pain in young ...

Patient reported outcomes and return to play after arthroscopic ...

Femoroacetabular impingement is a common cause of labral damage and hip pain in athletes. In severe labral tears with inadequate healthy labrum ...

Hip Preservation Surgery - Medical Clinical Policy Bulletins

A total of 96 consecutive patients (100 hips) with radiographically documented FAI were treated with hip arthroscopy, labral debridement or repair/refixation, ...

Safety and Efficacy of Femoroacetabular Impingement ...

These studies suggest that labral repair may result in better outcome. However, the evidence base for this is low. 4.4. There are 4 ongoing ...