Capsula Closure vs. Non-Capsula Closure: Hip Arthroscopy in Danish Patients With Femoroacetabular Impingement (FAI)

NCT03158454 | Active Not Recruiting

• 1 other identifier: Danish EC 1-10-72-279-16
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate whether patients undergoing surgical treatment (hip arthroscopy) of FAI syndrome will positively benefit from capsular closure, in terms of higher scores in validated patient reported outcome measurements, compared to a Group of patients with FAI syndrome where the capsule is left open at the end of the surgical procedure.

Conditions

Hip Injuries

Outcome Measures

Primary Outcomes (1)

• Change in patient reported outcome scores (Hagos)

  Copenhagen Hip and Groin Outcome Score - Questionnaire - Hip-function Score (0-100)

  From baseline to 2 year after the operation

Secondary Outcomes (4)

• Change in patient reported outcome scores (Ihot12)

  From baseline to 2 year after the operation

• Change in patient reported outcome scores (NRS)

  From baseline to 2 year after the operation

• Change in patient reported outcome scores (EQ5D

  From baseline to 2 year after the operation

• Reoperation

  Up to 2 years after surgery

Study Arms (2)

Capsula Closure

OTHER

Procedure: Capsula Closure

Non-Capsula Closure

OTHER

Procedure: Non-Capsula Closure

Interventions

Capsula Closure PROCEDURE

The capsular closure is performed with a minimum of two vicryl # 2 resorbable sutures

Capsula Closure

Non-Capsula Closure PROCEDURE

No capsular closure procedure is performed.

Non-Capsula Closure

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Radiological and symptomatic Femoroacetabular Impingement, where surgery is indicated. Preoperatively a minimum of 3 months of relevant physiotherapeutic treatment should have been performed.

You may not qualify if:

• Previous hip surgery in either hip
• Malignant disease
• Recent hip or pelvic fractures
• Arthritic disease
• Hip joint dysplasia
• Legg-Calvé-Perthes
• Slipped Capital Femoris Epiphysis
• Recent (within 6 weeks) medical treatment with corticosteroids
• Language problems of any kind

Sponsors & Collaborators

• Aarhus University Hospital: lead

Study Sites (1)

Division of Sports Trauma, Tage-Hansens Gade 2b

Aarhus, 8000, Denmark

Location

Related Publications (2)

• Mygind-Klavsen B, Kraemer O, Lund B, Krogsgaard M, Holmich P, Lind M, Nielsen TG, Miller LL, Philippon M, Dippmann C. Interportal Capsulotomy Closure Does Not Improve the Results After Hip Arthroscopy at 1-Year Follow-up: A Prospective Randomized Controlled Study. Orthop J Sports Med. 2025 Sep 5;13(9):23259671251363604. doi: 10.1177/23259671251363604. eCollection 2025 Sep.

  PMID: 40917599 DERIVED

• Dippmann C, Kraemer O, Lund B, Krogsgaard M, Holmich P, Lind M, Briggs K, Philippon M, Mygind-Klavsen B. Multicentre study on capsular closure versus non-capsular closure during hip arthroscopy in Danish patients with femoroacetabular impingement (FAI): protocol for a randomised controlled trial. BMJ Open. 2018 Feb 10;8(2):e019176. doi: 10.1136/bmjopen-2017-019176.

  PMID: 29440159 DERIVED

MeSH Terms

Conditions

Hip Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 15, 2017
• First Posted: May 18, 2017
• Study Start: June 15, 2017
• Primary Completion: December 1, 2022
• Study Completion (Estimated): December 1, 2028
• Last Updated: October 1, 2025

Record last verified: 2025-09

Locations

DK (1)