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

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).

Conditions

• Surgery

Interventions

PROCEDURE

Arthroscopic surgical procedures

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

Sponsors & Collaborators

• La Trobe University

  collaborator OTHER

• University of Aarhus

  collaborator OTHER

• Lund University

  collaborator OTHER

• University of Oxford

  collaborator OTHER

• University of Ottawa

  collaborator OTHER

• Oslo University Hospital

  lead OTHER

Principal Investigators

• May Arna Risberg, PT, PhD · Oslo University Hospital

• Lars Nordsletten, MD, PhD · Oslo University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-02-29

Primary Completion

2024-05-31

Completion

2035-12-31

Countries

• Australia
• Norway

Study Locations