Hip Capsule Repair for Hip Pain

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

250 Participants Needed

Trial Summary

What is the purpose of this trial?

Capsular REpair randomiSed controlled Trial (CREST) is a multi-center, randomized controlled trial with a sample size of 240 patients (120 patients in each group). The primary outcome measure is functional outcome as measured by the change in Hip Outcome Score at 6 months with secondary outcomes being hip range of motion, i-HOT 12, overall satisfaction, and VAS. Patients are stratified based on gender. Patients, outcome assessors, and data analysts are blinded to surgical allocation. Using an intention-to-treat approach, outcome analyses will be performed using an analysis of covariance and descriptive statistics.

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 data supports the effectiveness of the treatment Hip Capsule Repair for hip pain?

Research suggests that repairing the hip capsule during hip arthroscopy can improve outcomes for patients with femoroacetabular impingement, a condition that causes hip pain. This indicates that hip capsule repair might help reduce pain and improve hip function. ^{1 2 3 4 5}

Is hip capsule repair generally safe for humans?

Research on hip capsule repair during hip arthroplasty (joint replacement surgery) suggests that it may reduce the risk of dislocation, a common complication, without negative impacts on patient satisfaction or functional outcomes. However, general safety data specifically for hip capsule repair outside of arthroplasty is limited. ^{6 7 8 9 10}

How does hip capsule repair treatment differ from other treatments for hip pain?

Hip capsule repair is unique because it focuses on restoring the stability of the hip joint by repairing the capsule, which is a key stabilizer. This approach is particularly beneficial for patients with conditions like femoroacetabular impingement or hip dysplasia, where joint stability is compromised, unlike other treatments that may not address the capsule directly. ^{2 4 11 12 13}

Research Team

Aaron Krych, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Arthroscopic Hip Capsular Reconstruction Using Iliotibial Band Allograft as a Salvage Option for Unrepairable Capsular Defects Demonstrates Good Survivorship and Improved Patient-Reported Outcomes. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Integrity of the hip capsule measured with magnetic resonance imaging after capsular repair or unrepaired capsulotomy in hip arthroscopy. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Defining the Maximum Outcome Improvement of the Modified Harris Hip Score, the Nonarthritic Hip Score, the Visual Analog Scale For Pain, and the International Hip Outcome Tool-12 in the Arthroscopic Management for Femoroacetabular Impingement Syndrome and Labral Tear. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Capsular Repair May Improve Outcomes in Patients Undergoing Hip Arthroscopy for Femoroacetabular Impingement: A Systematic Review of Comparative Outcome Studies. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Healing of joint capsule after hip arthroscopy using interportal capsulotomy and capsular closure influences clinical outcomes. [2022]

6. Sweden pubmed.ncbi.nlm.nih.gov

Only 8% of major preventable adverse events after hip arthroplasty are filed as claims: a Swedish multi-center cohort study on 1,998 patients. [2021]

7. Belgium pubmed.ncbi.nlm.nih.gov

The prevalence and risk factors of dislocation after primary total hip arthroplasty. [2023]

8. Germany pubmed.ncbi.nlm.nih.gov

[The impact of capsular repair on the dislocation rate after primary total hip arthroplasty: a retrospective analysis of 1972 cases]. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Adverse Events due to Lack of Precision in Total Hip Arthroplasty: The Potential of Provocation-Based CT for Diagnosis of Implant Loosening. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Timing of adverse events in patients undergoing acute and elective hip arthroplasty surgery: a multicentre cohort study using the Global Trigger Tool. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Editorial Commentary: Interportal Capsulotomy for Hip Arthroscopy in Patients With Borderline Hip Dysplasia May Result in Inferior Outcomes: Periportal Capsulotomy May Reduce Hip Capsular Damage. [2023]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Arthroscopic Anchor-Based Hip Capsular Reconstruction Without Graft Augmentation. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Editorial Commentary: Hip Capsule: To Repair or Not? [2017]