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ACTIVE NOT RECRUITING
NCT02692807
NA

Arthroscopic Surgical Procedures vs Sham Surgery for Patients With Femoroacetabular Impingement and/or Labral Tears.

Sponsor: Oslo University Hospital

View on ClinicalTrials.gov

Summary

The primary aim of this study is to determine the efficacy of hip arthroscopic surgery compared to a sham surgery (diagnostic arthroscopy only) for patients with symptomatic and radiological findings related to impingement (FAI) and/or labral tears using a randomized controlled design (HIPARTI Study: Primary aim and the main paper: primary end point: iHOT 1 year follow-up)). Our main hypothesis is that surgical procedures of the hip will demonstrate greater efficacy than sham surgery (diagnostic hip arthroscopy only) for hip related quality of life (iHOT-33) after 1 year and at further (HIPARTI Study). The secondary aim of this study is to establish modifiable risk factors associated with pain, function, work participation and quality of life over 1 year in people aged 18-50 years with hip impingement and/or labral tears diagnosed at hip arthroscopy. (HARP Study: A separate paper will be published with this main aim for the HARP Study) Long-term follow-ups for HIPARTI Study as well as HARP Study will be performed at 2, 5 and 10 years (secondary aims and separate papers).

Official title: Arthroscopic Surgical Procedures Versus Sham Surgery for Patients With Femoroacetabular Impingement and/or Labral Tears. A Multicentre, International, Double-blinded Randomized, Controlled Trial.

Key Details

Gender

All

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

140

Start Date

2016-02

Completion Date

2035-12

Last Updated

2025-03-25

Healthy Volunteers

No

Conditions

Interventions

PROCEDURE

Arthroscopic surgical procedures

See arm/group description of Arthroscopic surgery and sham surgery (HIPARTI). HARP: only arthroscopic surgery

Locations (2)

LaTrobe University, School Allied Health, College of Science, Helath and Engineering

Melbourne, Victoria, Australia

Division of Orthopedic Surgery, Oslo University Hospital

Oslo, Norway