Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000680561
Ethics application status
Approved
Date submitted
24/05/2015
Date registered
1/07/2015
Date last updated
22/11/2018
Date data sharing statement initially provided
22/11/2018
Date results provided
22/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Capsule Repair After Arthroscopic Surgery of the Hip
Scientific title
MRI and functional outcomes following capsule repair after arthroscopic hip surgery.
Secondary ID [1] 286795 0
Nil
Universal Trial Number (UTN)
U1111-1145-1898
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Femoroacetabular Impingement 295170 0
Condition category
Condition code
Musculoskeletal 295414 295414 0 0
Other muscular and skeletal disorders
Surgery 295590 295590 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure

The Intervention is repair of the hip capsule at the end of an arthroscopic hip surgery. This consists of 2-4 heavy (number 2) surgical sutures passed with a special instrument (Arthrocare Speed stitch). The procedure adds about 5-10 minutes to a 60-90 minute operation.
Intervention code [1] 291953 0
Treatment: Surgery
Comparator / control treatment
The control is arthroscopic hip surgery performed without closure of the capsule. This has been the standard of care for the past 10 years internationally.
Control group
Active

Outcomes
Primary outcome [1] 295151 0
(1) iHOT Version 12
This is a validated patient generated subjective outcome measure of hip function.
Timepoint [1] 295151 0
6 weeks, 6 months, 1 year, 2 years
Primary outcome [2] 295299 0
(2) Marx activity score
Timepoint [2] 295299 0
3,6,12 and 24 months
Primary outcome [3] 295301 0
(3) ROM and stability testing.
Timepoint [3] 295301 0
3,6,12 and 24 months
Secondary outcome [1] 314882 0
(4) Post op VAS (days 3,7,21), (this is also a primary outcome)
Timepoint [1] 314882 0
Day 3,7,21
Secondary outcome [2] 315289 0
blood loss, (from operative record) capsulitis,(from routine clinic notes at follow up) number of days off
work, (from patient follow up visit notes) number of days off sports, pain killers taken, days till return to
run/bike/play.(All from patient follow up visits directly questioning patient) Documentation of mishaps / accidents with immediate
worsening of pain for a period of days or weeks or "setbacks" where the
hip pain has worsened for a period of days or weeks (Direct questions from patient clinic follow up visits)
(composite secondary outcome)
Timepoint [2] 315289 0
3,7,21 days
Secondary outcome [3] 315290 0
(2) MRI will be conducted at 6 weeks and 6 months post op to evaluate
capsular healing status (primary radiological outcome measure), intra
articular adhesions, extra articular scarring, labrum/cartilage status and
resection assessment. This MRI will be paid by department funds

The MRI features are a composite secondary outcome
Timepoint [3] 315290 0
6 weeks and 6 months

Eligibility
Key inclusion criteria
Inclusion Criteria
(1) Male or female patients aged between 18-51
(2) Healthy patients undergoing hip arthroscopy due to Cam or
mixed FAI
(3) No major osteoarthritic (OA) changes according to X-Ray
and surgery observation (Tonnis 0-1)
(4) No previous hip surgery
(5) No other influential disabilities in lower limbs
(6) No chronic use of NSAID, analgesics, steroids or
chemotherapy drugs
(7) Base line activity level (Tegner 3 and above)
Minimum age
18 Years
Maximum age
51 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria
(1) Patients with concomitant disease that may affect joints
(2) Patients with major ligamentous laxity
(3) Patients who have undergone only minor vertical
capsulotomy (as in small pincer only lesions)
(4) Patients with extreme range of motion needs (such as ballet
dancers)
(5) Patients suffering from connective tissue disease
(6) Patients suffering from bilateral symptomatic FAI that are
being operated on for their first hip
(7) Patients with relative or proven dysplastic hip determined by
center edge angle and/or extreme version abnormalities as
measured on apical CT/MR cuts and pelvic XR
(8) Patients who needed Ilio-Psoas release
(9) Patients whose cartilage hip status was defined as advanced
OA during surgery
(10) Patients who following surgery would be instructed to avoid
full weight bearing on the operated hip for more than 4
weeks
(11) Concomitant use of PRP (platelet rich plasma) or hyaluronic acid

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)
Description of Population to be Enrolled
a) The study will enroll approximately 60 individuals, 30 in each treatment
group, who have elected to undergo a hip arthroscopy due to labral or
cartilage pathologies as a result of Femoroacetabular Impingement.
b) Screening Procedures: Individuals will be recruited from current patients who are
being evaluated to undergo arthroscopic surgery for FAI as well as new patients.
Patients will be seen in Dr. Mei-Dan’s and Dr Brick's clinic and evaluated for involvement in the study
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stage 2: Randomization
i) Randomization will be performed by the surgeons/investigators
before the surgical procedure is about to conclude. Due to the
necessity of intra-operative evaluation of the hip cartilage for
evidence of OA, (which could exclude a patient from participation in
the study), randomization cannot be performed prior to this point.
ii) Sixty sealed envelopes, 30 of which are labeled “Treatment” or “Control”, will
be prepared prior to the initiation of the study, and will be placed in a closed
box in the operating room. After the technical aspects of the surgical
procedure have been completed, all pathologies were addressed, and before
skin closure, the nurse will open a sealed envelope and notify the surgeon if
capsular repair is to be performed. Patients will be (and stay) blinded to the treatment given
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/06/2014
Actual
18/06/2014
Date of last participant enrolment
Anticipated
20/01/2015
Actual
20/01/2015
Date of last data collection
Anticipated
Actual
31/10/2017
Sample size
Target
60
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 6900 0
New Zealand
State/province [1] 6900 0
Auckland
Country [2] 21060 0
United States of America
State/province [2] 21060 0
Colorado

Funding & Sponsors
Funding source category [1] 291337 0
Commercial sector/Industry
Name [1] 291337 0
Smith and Nephew
Country [1] 291337 0
New Zealand
Primary sponsor type
Individual
Name
Matthew Brick
Address
Orthosports North Harbour (private surgical practice of Dr Matthew Brick)
17 Antares Place
Mairangi Bay
Auckland 0632
Country
New Zealand
Secondary sponsor category [1] 290016 0
None
Name [1] 290016 0
Nil
Address [1] 290016 0
NIl
Country [1] 290016 0
Other collaborator category [1] 278479 0
Individual
Name [1] 278479 0
Dr Omer Mei-Dan
University of Colorado Sports Medicine Dept
Address [1] 278479 0
University of Colorado Sports Medicine Dept
465 University avenue
Colorado
Boulder 80302
USA
Country [1] 278479 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292900 0
HDEC
Ethics committee address [1] 292900 0
Ethics committee country [1] 292900 0
New Zealand
Date submitted for ethics approval [1] 292900 0
16/07/2013
Approval date [1] 292900 0
19/07/2013
Ethics approval number [1] 292900 0
13/STH/71

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

Contacts
Principal investigator
Name 57554 0
Dr Matthew Brick
Address 57554 0
Millennium Institute
17 Antares Place
Mairangi Bay
Auckland 0632
Country 57554 0
New Zealand
Phone 57554 0
+64 9 4772080
Fax 57554 0
+64 9 4750376
Email 57554 0
[email protected]
Contact person for public queries
Name 57555 0
Matthew Brick
Address 57555 0
Millennium Institute
17 Antares Place
Mairangi Bay
Auckland 0632
Country 57555 0
New Zealand
Phone 57555 0
+64 9 4772080
Fax 57555 0
Email 57555 0
[email protected]
Contact person for scientific queries
Name 57556 0
Matthew Brick
Address 57556 0
Millennium Institute
17 Antares Place
Mairangi Bay
Auckland 0632
Country 57556 0
New Zealand
Phone 57556 0
+64 9 477 2080
Fax 57556 0
+64 9 4750376
Email 57556 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No need to share data with other researchers as this is a stand-alone trial.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.