Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001655437
Ethics application status
Approved
Date submitted
28/11/2016
Date registered
30/11/2016
Date last updated
30/11/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Surgical Reconstruction of Gluteal Tendon Tears
Scientific title
Augmented Hip Abductor Reconstruction for Gluteal Tendon Tears
Secondary ID [1] 290632 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gluteal Tendon Tears 301151 0
Condition category
Condition code
Musculoskeletal 300917 300917 0 0
Other muscular and skeletal disorders
Injuries and Accidents 300918 300918 0 0
Other injuries and accidents
Surgery 300919 300919 0 0
Surgical techniques

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
All patients will undergo gluteal tendon reconstruction, augmented with a synthetic ligament, as outlined in detail below. This is the preferred operative technique of the orthopaedic surgeon involved in this research, and this surgical intervention is being undertaken regardless of whether patients choose to participate in the prospective clinical follow-up or not. As part of this prospective follow-up, patients will be evaluated pre-surgery and at 3, 6, 12 and 24 months post-surgery.

The surgical procedure is performed using general anesthesia, prophylactic antibiotics and an indwelling urinary catheter. In the lateral decubitus position, a 10cm longitudinal incision is made over the lateral aspect of the greater trochanter. The tensor fascia lata (TFL) is divided longitudinally, the same length as the skin incision. A 1-2 cm V-Y lengthening of the TFL investing fascia is performed. The thickened trochanteric bursa is excised to expose the insertion of the gluteus medius tendon into the lateral facet of the anterior greater trochanter. Subsequent evaluation of the tendon is performed for the extent of the tear and the presence or otherwise of an associated enthesiophyte. The involved portions of the tendon is elevated from the anterior greater trochanter. Any intact, generally posterior, fibres of the gluteus medius are not dissected from bone. The underlying bone on the footprint of the tendon insertion is decorticated with an osteotome to remove sclerotic reactive bone and enthesiophytes, exposing a bleeding bone surface ready to receive the prepared tendon. Tendinopathic tissue is excised from the tendon end. Any de-laminations of the tendons are then repaired. The repair in all cases is augmented with a LARS (ACTOR 10, Corin Group, Cirencester, UK) ligament which is cut longitudinally along the seam allowing the tube to fan. The flattened portion is sutured onto the under-surface of medius, or reflected minimus. Stay sutures in the reflected tendon ends aided retraction during LARS attachment. The LARS ligament is secured using 2-Ethibond sutures (Ethicon Inc., Johnson and Johnson, USA).

A 4.5 mm bone tunnel is drilled from the foot-print of gluteus minimus on the anterior facet of the greater trochanter, which exits postero-distal to the lateral prominence of the greater trochanter. A flexible looped wire passed through the bone tunnel permits passing of the draw-string on the free end of the LARS ligament through from antero-medial (deep) to lateral (superficial), and the deep surface of the tendon is drawn onto the footprint. A 5.2 mm interference screw (Corin, Cirencester, UK) is placed into the bone tunnel to secure the tension in the ligament/bone interface. The excess tail of the LARS ligament is trimmed. Subsequently, formal repair of the gluteal tendons to the anterior greater trochanter is performed with interosseous suture and bone anchors as indicated. The wound is closed in layers excluding the proximal fascia lata decompression. Patients are discharged from hospital 3-5 days after surgery, and two weeks of subcutaneous DVT prophylaxis is administered in all patients.
Intervention code [1] 296512 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 300331 0
Oxford Hip Score
Timepoint [1] 300331 0
24 months post-surgery
Secondary outcome [1] 329707 0
Harris Hip Score
Timepoint [1] 329707 0
24 months post-surgery
Secondary outcome [2] 329708 0
12-item Short Form Health Survey
Timepoint [2] 329708 0
24 months post-surgery
Secondary outcome [3] 329709 0
Visual Analogue Pain Scale
Timepoint [3] 329709 0
24 months post-surgery
Secondary outcome [4] 329710 0
Global Rating of Change Score
Timepoint [4] 329710 0
24 months post-surgery
Secondary outcome [5] 329711 0
Active Hip Range of Motion: evaluated on the affected/operated limb in all planes using either a hand-held bubble inclinometer (hip flexion in supine, internal and external rotation in prone) or a Jamar 'Registered Trademark' long arm goniometer (hip adduction and abduction in supine, extension in standing).
Timepoint [5] 329711 0
24 months post-surgery
Secondary outcome [6] 329712 0
30-second single leg stance (SLS) test on the affected/operated limb
Timepoint [6] 329712 0
24 months post-surgery
Secondary outcome [7] 329713 0
Maximal isometric hip abduction strength on both the affected/operated and unaffected limb, using a T5 Cable Tensiometer (Pacific Scientific Company, Los Angeles)
Timepoint [7] 329713 0
24 months post-surgery

Eligibility
Key inclusion criteria
All patients deemed candidates for gluteal tendon reconstruction surgery by the orthopaedic surgeon, will be asked to participate in this clinical pre- and post-operative follow-up.

Therefore, key inclusion criteria for surgery include:

1. clinical diagnosis of tendon tearing confirmed by magnetic resonance imaging (MRI), which includes partial or full thickness tears of gluteus minimus and/or gluteus medius.

2. All patients had previously failed a course of non-operative treatment including corticosteroid injections and physical therapy.
Minimum age
30 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
There are no specific exclusion criteria for study participation. Providing the above criteria are met required for surgical intervention, then all patients that undergo surgery will be offered participation in this clinical pre- and post-operative follow-up.

Study design
Purpose
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
With the Oxford Hip Score (OHS) as the primary outcome variable, a previous study reported that a sample size of 22 patients would have over 99% power to detect a mean change of 5 points, which has been suggested as the minimal clinically important difference for the OHS, assuming a standard deviation of the change score of 10, corresponding to a moderate effect size of 0.5.

Means (SD and range) will be presented for all measures. To investigate the progression of clinical (patient-reported outcome scores) and functional (hip range of motion, six-minute walk capacity, 30-second single leg stance capacity, hip abductor strength) outcomes over time, repeated measures analysis of variance (ANOVA) will be employed. Statistical analysis will be performed using SPSS software (SPSS, Version 17.0, SPSS Inc., USA), while statistical significance will be determined at p<0.05.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
22/10/2012
Date of last participant enrolment
Anticipated
30/06/2017
Actual
Date of last data collection
Anticipated
1/07/2019
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 6998 0
Hollywood Private Hospital - Nedlands
Recruitment hospital [2] 6999 0
Mount Hospital - Perth
Recruitment postcode(s) [1] 14729 0
6000 - Perth
Recruitment postcode(s) [2] 14728 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 295066 0
Hospital
Name [1] 295066 0
Hollywood Private Hospital Research Foundation
Country [1] 295066 0
Australia
Funding source category [2] 295067 0
Commercial sector/Industry
Name [2] 295067 0
Corin (Australia) Pty Ltd
Country [2] 295067 0
Australia
Primary sponsor type
Individual
Name
Jay R. Ebert
Address
Hollywood Functional Rehabilitation Clinic
Entrance 6, Verdun Street
Nedlands WA 6009
Country
Australia
Secondary sponsor category [1] 293877 0
None
Name [1] 293877 0
Address [1] 293877 0
Country [1] 293877 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296409 0
Hollywood Private Hospital
Ethics committee address [1] 296409 0
Monash Avenue, Nedlands, Western Australia, 6009
Ethics committee country [1] 296409 0
Australia
Date submitted for ethics approval [1] 296409 0
10/08/2012
Approval date [1] 296409 0
11/10/2012
Ethics approval number [1] 296409 0
HPH348

Summary
Brief summary
This is a non-randomized study that seeks to comprehensively evaluate the clinical and functional outcome of a consecutive series of patients undergoing gluteal tendon repair surgery augmented with a synthetic ligament. We hypothesize that symptomatic patients failing prior conservative treatment and with evidence of gluteal tendon tearing diagnosed via magnetic resonance imaging (MRI), will demonstrate significant clinical improvement up until 24 months post-surgery.
Trial website
Trial related presentations / publications
Bucher TA, Darcy P, Ebert JR, Smith A,Janes G. Gluteal tendon repair augmented with a synthetic ligament: surgical technique and a case series. Hip International. 2013; 24(2); 187-193.
Public notes
Attachments [1] 1275 1275 0 0
/AnzctrAttachments/371934-HPH348 Hip Abductor Ethics Approval.pdf (Ethics approval)

Contacts
Principal investigator
Name 70794 0
Dr Jay Ebert
Address 70794 0
Hollywood Functional Rehabilitation Clinic
Entrance 6, Verdun Street
Nedlands WA 6009
Country 70794 0
Australia
Phone 70794 0
+61 8 9386 9961
Fax 70794 0
+61 8 9346 6462
Email 70794 0
jayebert@hfrc.com.au
Contact person for public queries
Name 70795 0
Dr Jay Ebert
Address 70795 0
Hollywood Functional Rehabilitation Clinic
Entrance 6, Verdun Street
Nedlands WA 6009
Country 70795 0
Australia
Phone 70795 0
+61 8 9386 9961
Fax 70795 0
+61 8 9346 6462
Email 70795 0
jayebert@hfrc.com.au
Contact person for scientific queries
Name 70796 0
Dr Jay Ebert
Address 70796 0
Hollywood Functional Rehabilitation Clinic
Entrance 6, Verdun Street
Nedlands WA 6009
Country 70796 0
Australia
Phone 70796 0
+61 8 9386 9961
Fax 70796 0
+61 8 9346 6462
Email 70796 0
jayebert@hfrc.com.au

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseResponsiveness of the Victorian Institute for Sport Assessment for Gluteal Tendinopathy (VISA-G), modified Harris hip and Oxford hip scores in patients undergoing hip abductor tendon repair.2019https://dx.doi.org/10.1016/j.msksp.2019.05.005
EmbaseA Prospective 2-Year Clinical Evaluation of Augmented Hip Abductor Tendon Repair.2020https://dx.doi.org/10.1177/2325967119897881
N.B. These documents automatically identified may not have been verified by the study sponsor.