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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02692807




Registration number
NCT02692807
Ethics application status
Date submitted
15/02/2016
Date registered
26/02/2016

Titles & IDs
Public title
Arthroscopic Surgical Procedures vs Sham Surgery for Patients With Femoroacetabular Impingement and/or Labral Tears.
Scientific title
Arthroscopic Surgical Procedures Versus Sham Surgery for Patients With Femoroacetabular Impingement and/or Labral Tears. A Multicentre, International, Double-blinded Randomized, Controlled Trial.
Secondary ID [1] 0 0
2015091
Secondary ID [2] 0 0
NAR-1- 2016
Universal Trial Number (UTN)
Trial acronym
HIPARTI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Surgery 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Arthroscopic surgical procedures

Active comparator: Hip arthroscopy surgical procedures (HIPARTI Study) - 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.

Placebo comparator: Sham surgery (HIPARTI Study) - 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.

Active comparator: Prospective Cohort (HARP Study) - 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).


Treatment: Surgery: Arthroscopic surgical procedures
See arm/group description of Arthroscopic surgery and sham surgery (HIPARTI). HARP: only arthroscopic surgery
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
International Hip Outcome Tool (IHOT-33)
Timepoint [1] 0 0
Baseline, 6,12 an 24 months follow-ups - 1 year follow-up is main outcome
Secondary outcome [1] 0 0
Expectations of surgery
Timepoint [1] 0 0
Baseline
Secondary outcome [2] 0 0
HOOS - Hip Dysfunction and Osteoarthritis Outcome Score
Timepoint [2] 0 0
Baseline, 6,12 an 24 months follow-ups - only in some study sites
Secondary outcome [3] 0 0
ASES Arthritis Self-Efficacy Scale
Timepoint [3] 0 0
Baseline, 6,12 an 24 months follow-ups
Secondary outcome [4] 0 0
Tampa scale of Kinesiophobia
Timepoint [4] 0 0
Baseline, 6,12 an 24 months follow-ups
Secondary outcome [5] 0 0
Hip Sports Activity Scale (HSAS)
Timepoint [5] 0 0
Baseline, 6,12 an 24 months follow-ups
Secondary outcome [6] 0 0
Work place Activity Limitation Survey (WALS)
Timepoint [6] 0 0
Baseline, 6,12 an 24 months follow-ups
Secondary outcome [7] 0 0
Patient Spesific Functional Scale
Timepoint [7] 0 0
Baseline, 6,12 an 24 months follow-up
Secondary outcome [8] 0 0
Measures of hip physical impairment:
Timepoint [8] 0 0
Baseline, 6,12 an 24 months follow-ups
Secondary outcome [9] 0 0
Hip muscle strength
Timepoint [9] 0 0
Baseline, 6,12 an 24 months follow-ups
Secondary outcome [10] 0 0
Single leg squat performance
Timepoint [10] 0 0
Baseline, 6,12 an 24 months follow-ups
Secondary outcome [11] 0 0
Total Hip Replacement.
Timepoint [11] 0 0
1, 2, 5 and 10 years follow-up

Eligibility
Key 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
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2035
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
LaTrobe University, School Allied Health, College of Science, Helath and Engineering - Melbourne
Recruitment postcode(s) [1] 0 0
3086 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Norway
State/province [1] 0 0
Oslo

Funding & Sponsors
Primary sponsor type
Other
Name
Oslo University Hospital
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
La Trobe University
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University of Aarhus
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Lund University
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
University of Oxford
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
University of Ottawa
Address [5] 0 0
Country [5] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
May Arna Risberg, PT, PhD
Address 0 0
Oslo University Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
May Arna Risberg, PT, PhD
Address 0 0
Country 0 0
Phone 0 0
4741312776
Fax 0 0
Email 0 0
m.a.risberg@nih.no
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
Data will be shared across the sites participating in the HIPARTI and the HARP Study, according to the protocol and the decisions made by the Advisory Committee


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02692807