Hip Capsule Repair for Hip Pain

Not currently recruiting at 2 trial locations

Overseen By Karina Gonzalez Carta

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: Immunosuppressants

Disqualifiers: Hypermobility, Hip dysplasia, Diabetes, others

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

Compensation: Varies

Number of Visits: 7

Duration: Surgery and immediate recovery

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether repairing the hip capsule, a protective tissue around the hip joint, can reduce hip pain and improve movement. It compares patients who undergo hip capsule repair during surgery to those who do not. The goal is to determine if the repair leads to better outcomes for individuals with hip pain unresponsive to other treatments. This trial may suit adults who have experienced persistent hip pain for over three months, despite trying physical therapy or medication. As an unphased trial, it provides a unique opportunity to explore innovative treatment options for those seeking relief from chronic hip pain.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on immunosuppressant medication, you would not be eligible to participate.

What prior data suggests that this hip capsule repair technique is safe?

Research has shown that hip capsule repair, a procedure often performed during hip arthroscopy, is generally safe for patients. One study found complications to be uncommon, with minor issues occurring in about 4.5% to 7.9% of cases, while major problems were even rarer. Another study indicated that closing the hip capsule after surgery did not negatively affect patient recovery or function. These findings suggest that the procedure is well-tolerated, with a low risk of serious side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about hip capsule repair for hip pain because it offers a new approach to addressing joint issues directly at the source. Unlike standard treatments, which might include physical therapy, medication, or less invasive surgical techniques, this method involves a detailed arthroscopic procedure that allows for a comprehensive assessment and repair of the hip's internal structures. By directly treating pathologies in both the central and peripheral compartments and repairing the hip capsule itself, this technique aims to provide more effective and lasting relief from pain. The use of simple interrupted sutures with absorbable material ensures a precise and potentially more natural healing process. This focus on repairing the hip capsule distinguishes it from other treatments, potentially leading to improved outcomes for patients with persistent hip pain.

What evidence suggests that hip capsule repair is effective for hip pain?

Research shows that repairing the hip capsule after arthroscopy, a minimally invasive joint surgery, leads to better patient outcomes. In this trial, participants in the Hip Capsule Repair group will undergo this procedure. Studies have found that patients who receive this repair often experience improved hip function compared to those who do not. A review of multiple studies found that routinely stitching the capsule back together results in fewer complications and a smoother recovery. Additionally, using self-dissolving stitches has been associated with positive patient feedback. Overall, repairing the capsule aids recovery and reduces the need for additional surgeries in patients without arthritis. ^{1 4 6 7 8}

Who Is on the Research Team?

Aaron Krych, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

The CREST trial is for adults aged 18 to 50 with hip pain lasting over three months that hasn't improved with non-surgical treatments. Participants must have FAI confirmed by imaging, an intact labrum or one repaired during surgery, and be able to understand and speak English.

Inclusion Criteria

My hip issue is confirmed by an X-Ray, MRI, or MRA.

I have had hip pain for over 3 months and treatments like physical therapy or painkillers haven't helped.

I have had surgery to fix or have an intact shoulder labrum.

Exclusion Criteria

Evidence of hip dysplasia (Center edge angle less than 20)

I have an inflammatory or autoimmune disease.

Worker's compensation status

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo arthroscopic hip surgery with or without capsular repair

Surgery and immediate recovery

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Follow-up at 6 weeks, 3 months, 6 months, 12 months, and 24 months

What Are the Treatments Tested in This Trial?

Interventions

• Hip Capsule Repair

Trial Overview This study tests if repairing the hip capsule during arthroscopy improves function. It involves 240 patients split into two groups, comparing outcomes like hip motion and satisfaction at six months post-surgery using a blinded approach.

How Is the Trial Designed?

Group I: Hip Capsule Repair Experimental Treatment 1 Intervention

Patients in the intervention group (Hip capsule repair) will undergo initial diagnostic arthroscopy of the hip. Two to three standard portals (anterolateral, mid anterior, distal antero-lateral, posterolateral) will be used during the entire procedure to assess and treat the patient. After establishing standard portals, an interportal capsulotomy is completed to allow for complete evaluation of the central compartment of the hip. In the central compartment, significant and obvious pathologies will be addressed accordingly. Following addressing central compartment pathologies, cam impingement type lesions in the peripheral compartment will be treated. Once all pathologies are addressed, the interportal capsulotomy10 will be repaired by using simple interrupted sutures with absorbable suture (Number 1 Vicryl). Three to four simples sutures will be placed and tied using arthroscopic technique.

Group II: No Hip Capsule Repair (Control) Active Control 1 Intervention

Patients in the control group (no hip capsule repair) have the same portals utilized and will have the same interportal capsulotomy performed. They will have all central and peripheral compartment pathologies addressed in the same way that the study group does. At the conclusion of the case, the hip capsule will be left open and not repaired.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11144363/

Capsular Repair Versus No Repair After Hip Arthroscopy in ... Capsular repair after hip arthroscopy was associated with superior clinical outcomes when compared with no capsular repair in patients without dysplasia or GLL.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0749806324010107

Meta-analysis Routine Capsular Closure Outperforms ... This study found an increased proportion of well outcomes with decreased rates of moderate (requiring revision hip arthroscopy) and major (requiring early ...

3. journaloei.scholasticahq.com journaloei.scholasticahq.com/article/141825-hip-capsule-closure-using-absorbable-sutures-demonstrates-similar-patient-reported-outcomes-and-rates-of-revision-with-potentially-lower-complication

Hip Capsule Closure Using Absorbable Sutures ... The primary findings of our study demonstrated that absorbable suture material for hip capsular closure showed comparable outcomes and revision ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03372564

CREST: Capsular Repair During Hip Arthroscopy The goal of the CREST is to evaluate functional stability and patient reported outcome scores following capsular repair after arthroscopic hip surgery for FAI.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33887416/

Capsular Repair May Improve Outcomes in Patients ... Conclusions: Midterm outcome studies suggest that capsular repair is safe and effective in patients without arthritis who are undergoing hip arthroscopy, and ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0976566224004661

Outcomes and complications of hip arthroscopy for ... Moreover, hip arthroscopy demonstrates a favorable safety profile, with minor complications occurring in 4.5–7.9 % of cases and major complications in less than ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8120543/

Does Capsular Closure Affect Clinical Outcomes in Hip ... Capsular closure appears to have no detrimental effect on functional outcome scores after hip arthroscopy. We recommend restoration of native anatomy if ...

8. arthroscopytechniques.org arthroscopytechniques.org/article/S2212-6287(23)00354-7/fulltext

Interportal and T-Capsulotomy, Suspension, and Closure We present an effective method for capsular management in hip arthroscopy that consistently allows excellent exposure and working space.