Knotless Implants As an Alternative for Capsular Closure in Primary Hip Arthroscopy: a Prospective, Multi-Center Study

NCT06500364 | Recruiting Phase 4 FDA Device

• 1 other identifier: IIRR-01891
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to see if the Arthrex LoopLocTM device is better for capsular closure during hip arthroscopy than other treatments available. The hip capsule is the tissue that surrounds your hip joint. It stabilizes and supports your hip joint. During hip arthroscopy, this tissue must be cut through in order to perform the hip arthroscopy. Once the hip arthroscopy is completed, the surgeon might repair the capsule. Current ways of repairing the capsule include knotted suture that might irritate structures around the hip, leading to the possible formation of scar tissue and pain. The Arthrex LoopLocTM device is knotless and may lower the presence of irritation and scar tissue around the hip after surgery and might lead to better outcomes. Therefore, researchers will compare patients who had the LoopLocTM device used to close their hip capsule during surgery to those who did not have the device used, to see if there is a difference in their outcomes following surgery.

Conditions

Femoro Acetabular Impingement

Keywords

Hip arthroscopy; Hip capsule

Outcome Measures

Primary Outcomes (1)

• Modified Harris Hip Score

  Patient-reported outcome measure. Scale 0-100, 100 indicating optimal function outcome.

  2 years

Secondary Outcomes (5)

• Non-Arthritic Hip Score

  2 years

• International Hip Outcome Tool

  2 years

• Hip Outcome Score Sports-Specific Subscale

  2 years

• Visual Analog Scale

  2 years

• Patient Satisfaction

  2 years

Study Arms (2)

LoopLoc Arm

EXPERIMENTAL

The patients in this group will have the LoopLoc device used following their hip arthroscopy, to close the capsule.

Device: LoopLoc Arm

Control Arm

ACTIVE COMPARATOR

This is a control group, meaning they had their hip arthroscopy done without the use of the LoopLoc device.

Device: Control Arm

Interventions

LoopLoc Arm DEVICE

Patients in this intervention will have had a capsular closure performed using a LoopLoc device after their hip arthroscopy.

LoopLoc Arm

Control Arm DEVICE

Patients in this intervention will have not had a capsular closure using a LoopLoc device after their hip arthroscopy.

Control Arm

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients undergoing a primary hip arthroscopy
• Patients younger than 60 years old.
• Patients who will receive capsular closure with the Arthrex LoopLocTM device following hip arthroscopy.

You may not qualify if:

• Patients that had previous hip surgery,
• Patients that had a center edge angle (CEA) less than 25 degrees or greater than 40 degrees.
• Patients that have a cartilage damage grade greater than or equal to 3.

Sponsors & Collaborators

• American Hip Institute: lead
• Arthrex, Inc.: collaborator

Study Sites (1)

American Hip Institute Research Foundation

Des Plaines, Illinois, 60018, United States

RECRUITING

Related Publications (11)

• Barber FA, Lee Evanson JR. Editorial Commentary: Acetabular Labral Repair-Is A Knotless Anchor Better? Arthroscopy. 2019 Jan;35(1):77-79. doi: 10.1016/j.arthro.2018.09.003.

  PMID: 30611369 BACKGROUND

• Carbone AD, Prabhavalkar O, Chishti Z, Curley AJ, Parsa A, Domb BG. Hip Capsular Repair Results in Improved Patient-Reported Outcomes and Survivorship: A Systematic Review of the Literature. Arthroscopy. 2023 Feb;39(2):488-497. doi: 10.1016/j.arthro.2022.11.013. Epub 2022 Nov 14.

  PMID: 36395962 BACKGROUND

• Conaway WK, Martin SD. Puncture Capsulotomy During Hip Arthroscopy for Femoroacetabular Impingement: Preserving Anatomy and Biomechanics. Arthrosc Tech. 2017 Nov 27;6(6):e2265-e2269. doi: 10.1016/j.eats.2017.08.036. eCollection 2017 Dec.

  PMID: 29349029 BACKGROUND

• Beck EC, Cvetanovich GL, Levy DM, Weber AE, Kuhns BD, Khair MM, Rasio J, Nho SJ. A T-capsulotomy provides increased hip joint visualization compared with an extended interportal capsulotomy: commentary response. J Hip Preserv Surg. 2019 Nov 23;6(3):290-291. doi: 10.1093/jhps/hnz043. eCollection 2019 Aug. No abstract available.

  PMID: 31798933 BACKGROUND

• Domb BG, Chaharbakhshi EO, Perets I, Walsh JP, Yuen LC, Ashberg LJ. Patient-Reported Outcomes of Capsular Repair Versus Capsulotomy in Patients Undergoing Hip Arthroscopy: Minimum 5-Year Follow-up-A Matched Comparison Study. Arthroscopy. 2018 Mar;34(3):853-863.e1. doi: 10.1016/j.arthro.2017.10.019. Epub 2018 Jan 17.

  PMID: 29373289 BACKGROUND

• Economopoulos KJ, Chhabra A, Kweon C. Prospective Randomized Comparison of Capsular Management Techniques During Hip Arthroscopy. Am J Sports Med. 2020 Feb;48(2):395-402. doi: 10.1177/0363546519894301. Epub 2019 Dec 31.

  PMID: 31891553 BACKGROUND

• Looney AM, McCann JA, Connolly PT, Comfort SM, Curley AJ, Postma WF. Routine Capsular Closure With Hip Arthroscopic Surgery Results in Superior Outcomes: A Systematic Review and Meta-analysis. Am J Sports Med. 2022 Jun;50(7):2007-2022. doi: 10.1177/03635465211023508. Epub 2021 Aug 17.

  PMID: 34403279 BACKGROUND

• Monroe EJ, Chambers CC, Zhang AL. Periportal Capsulotomy: A Technique for Limited Violation of the Hip Capsule During Arthroscopy for Femoroacetabular Impingement. Arthrosc Tech. 2019 Jan 28;8(2):e205-e208. doi: 10.1016/j.eats.2018.10.015. eCollection 2019 Feb.

  PMID: 30906690 BACKGROUND

• Ortiz-Declet V, Mu B, Chen AW, Litrenta J, Perets I, Yuen LC, Domb BG. Should the Capsule Be Repaired or Plicated After Hip Arthroscopy for Labral Tears Associated With Femoroacetabular Impingement or Instability? A Systematic Review. Arthroscopy. 2018 Jan;34(1):303-318. doi: 10.1016/j.arthro.2017.06.030. Epub 2017 Aug 31.

  PMID: 28866345 BACKGROUND

• Radha S, Hutt J, Lall A, Domb B, Lynch TS, Griffin D, Field RE, Chuck-Cakic J. Best practice guidelines for arthroscopic intervention in femoroacetabular impingement syndrome: results from an International Delphi Consensus Project-Phase 1. J Hip Preserv Surg. 2019 Dec 16;6(4):326-338. doi: 10.1093/jhps/hnz055. eCollection 2019 Dec.

  PMID: 32015889 BACKGROUND

• Willimon SC, Briggs KK, Philippon MJ. Intra-articular adhesions following hip arthroscopy: a risk factor analysis. Knee Surg Sports Traumatol Arthrosc. 2014 Apr;22(4):822-5. doi: 10.1007/s00167-013-2728-0. Epub 2013 Oct 26.

  PMID: 24162717 BACKGROUND

MeSH Terms

Conditions

Femoracetabular Impingement

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Alexandra Mantice

CONTACT

8338724477; alexandra.mantice@americanhipinstitute.org

Benjamin Domb

CONTACT

8338724477; drdomb@americanhipinstitute.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2024
• First Posted: July 15, 2024
• Study Start: October 29, 2024
• Primary Completion: August 1, 2025
• Study Completion (Estimated): August 1, 2027
• Last Updated: January 1, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)