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Trial registered on ANZCTR


Registration number
ACTRN12615001217594
Ethics application status
Approved
Date submitted
5/11/2015
Date registered
9/11/2015
Date last updated
9/02/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Surgical vs nonsurgical management for severe chronic greater trochanteric pain syndrome: a randomised controlled trial
Scientific title
Endoscopic iliotibial band release and trochanteric bursectomy for recalcitrant greater trochanteric pain syndrome: a randomised controlled trial comparing operative to nonoperative management and their outcomes on pain and function
Secondary ID [1] 287803 0
Nil known
Universal Trial Number (UTN)
U1111-1176-2154
Trial acronym
SURGTPS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Greater trochanteric pain syndrome 296686 0
Condition category
Condition code
Surgery 296922 296922 0 0
Other surgery
Musculoskeletal 296923 296923 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group: Will receive the surgical standard of care for greater trochanteric pain syndrome, consisting of endoscopic iliotibial band release and trochanteric bursectomy

This will be performed under general anaesthesia by the principal investigator, a consultant orthopaedic surgeon and will take approximately 30 minutes. There is no need to monitor adherence to this intervention.
Intervention code [1] 293199 0
Treatment: Surgery
Comparator / control treatment
Control group: Participants in this group will only receive advice to continue along their daily lives. They will not receive any other specific treatment. They will be free to seek treatment outside of the trial and this will be recorded on the satisfaction questionnaire. If this treatment outside of the trial consists of surgery, they will be excluded from the trial.
Control group
Active

Outcomes
Primary outcome [1] 296529 0
Pain measured on Visual Analogue Scale
Timepoint [1] 296529 0
This data will be collected pre-randomisation at an outpatient appointment at Western Health. We will aim to standardise this to occur within 8-12 weeks prior to surgery for patients that end up being randomised into the surgical group but this may change due to variable public hospital surgical waitlist times.

This will also be collected post-operatively or post-randomisation into nonop group at 6 weeks, 6 months, 12 months and 24 months after intervention via a mail out of the survey.
Primary outcome [2] 296530 0
Pain and function measured on Oxford Hip Score
Timepoint [2] 296530 0
This data will be collected pre-randomisation at an outpatient appointment at Western Health. We will aim to standardise this to occur within 8-12 weeks prior to surgery for patients that end up being randomised into the surgical group but this may change due to variable public hospital surgical waitlist times.

This will also be collected post-operatively or post-randomisation into nonop group at 6 weeks, 6 months, 12 months and 24 months after intervention via a mail out of the survey.
Primary outcome [3] 296531 0
Pain and function measured on international hip outcome tool 33 (iHOT33)
Timepoint [3] 296531 0
This data will be collected pre-randomisation at an outpatient appointment at Western Health. We will aim to standardise this to occur within 8-12 weeks prior to surgery for patients that end up being randomised into the surgical group but this may change due to variable public hospital surgical waitlist times.

This will also be collected post-operatively or post-randomisation into nonop group at 6 weeks, 6 months, 12 months and 24 months after intervention via a mail out of the survey.
Secondary outcome [1] 318693 0
Patient satisfaction with intervention outcome measured using a 5 point Likert scale
Timepoint [1] 318693 0
This data will be collected post-operatively or post-randomisation into nonop group at 6 weeks, 6 months, 12 months and 24 months after intervention via a mail out of the survey.
Secondary outcome [2] 318694 0
Patient likelihood to have intervention again measured on 5 point Likert scale
Timepoint [2] 318694 0
This data will be collected post-operatively or post-randomisation into nonop group at 6 weeks, 6 months, 12 months and 24 months after intervention via a mail out of the survey.

Eligibility
Key inclusion criteria
Adult patients (age >18yrs)

GTPS diagnosed clinically by the principal investigator (according to following criteria – must have 1 & 2, as well as one of 3-5):
1. History of aching pain on lateral aspect of hip
2. Distinct tenderness about the greater trochanter
3. Pain at extremes of hip rotation
4. Pain on strong contraction of hip abductors
5. Pseudoradiculopathy (pain radiating down lateral thigh)

Have had minimum 6 months of symptoms

Failed minimum of 6 months of non-operative treatment for their symptoms (rest/physiotherapy/corticosteroid injection)

Have had minimum one previous corticosteroid injection into area of affected hip (not intra-articular)

Have optimised non-operative management (e.g. on appropriate analgesics, have medical comorbidities well controlled)

Have an ultrasound or MRI scan showing signs of GTPS (gluteal tendinopathy, bursitis) without a full thickness gluteal muscle or tendon tear

Have had hip x-ray prior to intervention showing no or mild arthritis (Tonnis grade 0 or 1)

Have no clinical signs of other pathology not related to GTPS that can cause lateral hip/thigh or groin pain on their affected side
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any previous surgery on affected hip (e.g. arthroscopy, total hip replacement)

Other pathology involving affected hip region that can mimic pain of GTPS, for example:
Moderate to severe hip arthritis (Tonnis grade 2-3)
Labral tear
Femoroacetabular impingement
Lumbar radiculopathy
Hip dysplasia
Fibromyalgia

Full thickness gluteal muscle tear on affected side (diagnosed clinically and on US/MRI)

Does not speak English

Unable to complete questionnaires due to mental/physical comorbidities

Person is known to have a psychological, developmental, physical, emotional or social disorder that may interfere with compliance with study requirements

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)
Individuals are randomised by a computer-generated list by securenvelope, an online computer generated randomisation service, maintained centrally
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple random allocation via securenvelope, an online computer generated randomisation service
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Our hypothesis is that surgical intervention consisting of ITB release and trochanteric bursectomy for recalcitrant GTPS will result in a clinically important improvement in patient’s pain and function.

We have selected a sample size that will be viable for recruiting from a single surgeon while being powered enough to detect a minimally important difference between groups on the primary outcome measures (Cohen’s d = 0.6) with an alpha value of 0.05 and a beta value of 0.2. We have assumed a difference of 1.5/10 on VAS, 6/48 on OHS and 15/100 on iHOT33 as being clinically important for these groups and have used this to generate a Cohen's d of 0.6 to get a sample size of 90.

Continuous data such as VAS, OHS, iHOT33 score, age and BMI will be reported in terms of the mean and 95% confidence interval. The means of continuous data between intervention arms will be compared using the t-test.

Dichotomous data such as gender, diabetes and smoking will be compared using the Chi2 test.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
8/02/2016
Actual
Date of last participant enrolment
Anticipated
1/01/2018
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 4580 0
Western Hospital - Footscray
Recruitment hospital [2] 4581 0
Sunshine Hospital - St Albans
Recruitment postcode(s) [1] 12185 0
3011 - Footscray
Recruitment postcode(s) [2] 12186 0
3021 - St Albans

Funding & Sponsors
Funding source category [1] 292337 0
Hospital
Name [1] 292337 0
Western Health
Country [1] 292337 0
Australia
Primary sponsor type
Hospital
Name
Western Health
Address
160 Gordon Street
Footscray
VIC, 3011
Country
Australia
Secondary sponsor category [1] 291017 0
None
Name [1] 291017 0
Address [1] 291017 0
Country [1] 291017 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293803 0
St Vincent's HREC D
Ethics committee address [1] 293803 0
Research Governance Unit
Level 5, Mary Aikenhead Building
27 Victoria Parade
Fitzroy, VIC 3065
Ethics committee country [1] 293803 0
Australia
Date submitted for ethics approval [1] 293803 0
17/11/2015
Approval date [1] 293803 0
01/02/2016
Ethics approval number [1] 293803 0

Summary
Brief summary
This is a parallel randomised controlled trial comparing operative versus nonoperative management for recalcitrant greater trochanteric pain syndrome (GTPS). While the majority of cases of GTPS improve significantly or resolve with nonoperative management, there is no evidence that compares operative to nonoperative management when the condition is deemed recalcitrant (after 6 months of symptoms).

We are looking to investigate the natural history of the condition (what occurs when no treatment is given over a period of time). To do this, we are comparing nonoperative management consisting only of advice to continue your normal daily life with surgical treatment for the condition. Current surgical standard of care for recalcitrant GTPS consists of endoscopic iliotibial band release and trochanteric bursectomy. The study aims to investigate whether surgical intervention leads to reduced pain and improved function compared with continued nonoperative management in the treatment of recalcitrant greater trochanteric pain syndrome.

This study will be conducted as a randomised controlled trial with the control arm receiving advice to continue along their daily life for the period of the trial. The intervention arm will receive the current surgical standard of care, consisting of endoscopic iliotibial band release and trochanteric bursectomy.

Our hypothesis is there will be an improvement in the pain and function in the intervention group receiving the surgery compared to the control group. We are hoping this will result in a change in standard practice for this group of patients, whereby patients with severe recalcitrant GTPS symptoms undergo an appropriate intervention for their pain.

At the end of the trial, any patients with ongoing pain despite the continued non-operative treatment will be offered the surgical treatment if they desire.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 61370 0
Mr Phong Tran
Address 61370 0
ATTN: Lidia Carbone (orthopaedic Secretary)
Department of Orthopaedics, Western Health
Western Hospital
Level 1 South, 160 Gordon St
Footscray, VIC 3011
Country 61370 0
Australia
Phone 61370 0
+61 3 8345 7575
Fax 61370 0
+61 3 8345 7579
Email 61370 0
[email protected]
Contact person for public queries
Name 61371 0
James Drummond
Address 61371 0
ATTN: Lidia Carbone (orthopaedic Secretary)
Department of Orthopaedics, Western Health
Western Hospital
Level 1 South, 160 Gordon St
Footscray, VIC 3011
Country 61371 0
Australia
Phone 61371 0
+61 3 8345 7575
Fax 61371 0
+61 3 8345 7579
Email 61371 0
[email protected]
Contact person for scientific queries
Name 61372 0
James Drummond
Address 61372 0
ATTN: Lidia Carbone (orthopaedic Secretary)
Department of Orthopaedics, Western Health
Western Hospital
Level 1 South, 160 Gordon St
Footscray, VIC 3011
Country 61372 0
Australia
Phone 61372 0
+61 3 8345 7575
Fax 61372 0
+61 3 8345 7579
Email 61372 0
[email protected]

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

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