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

NCT02692807 | Active Not Recruiting

• 2 other identifiers: NAR-1- 20162015091
• Study Type: interventional
• Target: 140
• Locations: 2 countries
• Sites: 2

Brief 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

Keywords

hip arthroscopy; femoroacetabular impingement; exercise therapy after hip arthroscopy; rehabilitation after hip arthroscopy

Outcome Measures

Primary Outcomes (1)

• International Hip Outcome Tool (IHOT-33)

  Patient-reported outcome measure (PRO)

  Baseline, 6,12 an 24 months follow-ups - 1 year follow-up is main outcome

Secondary Outcomes (11)

• Expectations of surgery

  Baseline

• HOOS - Hip Dysfunction and Osteoarthritis Outcome Score

  Baseline, 6,12 an 24 months follow-ups - only in some study sites

• ASES Arthritis Self-Efficacy Scale

  Baseline, 6,12 an 24 months follow-ups

• Tampa scale of Kinesiophobia

  Baseline, 6,12 an 24 months follow-ups

• Hip Sports Activity Scale (HSAS)

  Baseline, 6,12 an 24 months follow-ups

Study Arms (3)

Hip arthroscopy surgical procedures (HIPARTI Study)

ACTIVE COMPARATOR

Surgery is performed under general anaesthesia. Traction and joint access is controlled by fluoroscopy. A diagnostic round in the central and peripheral compartment is performed. Labrum, cartilage, and other possible conditions are looked for and findings are documented. Any labral, chondral and bony pathology (cam or pincer) is treated. Labrum may be debrided, sutured, detached and refixed if needed to treat a pincer lesion. Labrum is secured with suture anchors. Pincer and cam resection is performed using an arthroscopic burr. Cartilage lesions maybe left untreated or treated with debridement or microfracture.

Procedure: Arthroscopic surgical procedures

Sham surgery (HIPARTI Study)

PLACEBO COMPARATOR

The same arthroscopic procedures as stated above are preformed, but no surgical interventions related to Cam, Pincer, or labral tear are performed, only diagnostic round in the central and peripheral compartment is performed. Labrum, cartilage, and other possible conditions are looked for and findings are documented.

Procedure: Arthroscopic surgical procedures

Prospective Cohort (HARP Study)

ACTIVE COMPARATOR

Those that are not willing to be included in the RCT (HIPARTI Study), will be asked if they are willing to be included in the prospective cohort, or ongoing in countries were ONLY the surgery is performed (Australia). They will sign an informed concent and will undergo surgical interventions as part of usual care. Outcomes collected and follow-ups will be the same as for the RCT (HIPARTI).

Procedure: Arthroscopic surgical procedures

Interventions

Arthroscopic surgical procedures PROCEDURE

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

Also known as: Sham Surgery

Hip arthroscopy surgical procedures (HIPARTI Study); Prospective Cohort (HARP Study); Sham surgery (HIPARTI Study)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo University Hospital: lead
• La Trobe University: collaborator
• University of Aarhus: collaborator
• Lund University: collaborator
• University of Oxford: collaborator
• University of Ottawa: collaborator

Study Sites (2)

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

Melbourne, Victoria, 3086, Australia

Location

Division of Orthopedic Surgery, Oslo University Hospital

Oslo, 4956, Norway

Location

MeSH Terms

Conditions

Femoracetabular Impingement

Interventions

Arthroscopy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Orthopedic Procedures

Study Officials

• May Arna Risberg, PT, PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

• Lars Nordsletten, MD, PhD

  Oslo University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: This is only for the RCT Study - the double-blinded study. The HARP study consists of only a prospective longitudinal study With same outcome measure and follow-ups; hence, given 3 arms. The below "Allocation" and "Number of Subjects" is ONLY for the RCT part of the study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The RCT part of the HIPARTI Study has 2 arms, but there is also a prospective longitudinal study of those who are either not willing to participate in the RCT, or where the study takes part in collaborating countries were there is ONLY the prospective longitudinal ongoing (Australia). This part of the study is the HARP study. The HIPARTI consists on one RCT trial with two parallel arms, and one prospective cohort, the HARP study.

Study Record Dates

• First Submitted: February 15, 2016
• First Posted: February 26, 2016
• Study Start: February 1, 2016
• Primary Completion: May 1, 2024
• Study Completion (Estimated): December 1, 2035
• Last Updated: March 25, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); NO (1)