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Clinical Trials in Australia / NCT02692807
Active, not recruiting Not applicable

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

NCT02692807 · tracked via the Priya Life Science Australia tracker
Phase
Not applicable
Started
2016-02
Last updated
2025-03-25

Condition(s) studied

Surgery

Investigational drug(s) / intervention(s)

Arthroscopic surgical procedures

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

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
50 Years
Healthy volunteers
No
Inclusion Criteria: * hip pain during daily and/or spor t ing activities; * intra-articular hip pain with radiological signs of FAI and/or labral tears eligible for hip arthroscopy (to be determined in a pragmatic fashion by the surgeon based on clinical examination and imaging * the patient is able to give written informed consent and to participate fully in the interventions and follow-up procedures Exclusion Criteria: * pain that is not confirmed by physical examination of the hip * evidence of preexisting osteoarthritis, defined as Tonnis grade \>1, or less than 3mm superior joint space width on AP pelvic radiograph * center edge angle on radiograph \<25°; (v) previous known hip pathology such as Perthes' disease, slipped upper femoral epiphysis or avascular necrosis * previous hip injury such as acetabular fracture, hip dislocation or femoral neck fracture * previous hip surgery * medical conditions complicating surgery (ASA 3); (ix) inflammatory joint disease (RA, Bechterew etc) * physical inability to undertake testing procedures * expected lack of compliance such as cognitive impairment, drug abuse or similar; * inability to understand the written and spoken language of the treatment centre; * contra-indications to placebo surgery, which will include large loose body, chondral flap \>1cm2 detached at 3 sides, complete labral radial flap tear and labral bucket-handle tear with complete avulsion \>1.5cm long

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
LaTrobe University, School Allied Health, College of Science, Helath and Engineering Melbourne Victoria
Division of Orthopedic Surgery, Oslo University Hospital Oslo Norway

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02692807 on ClinicalTrials.gov ↗ ← All trials in Australia