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Trial registered on ANZCTR


Registration number
ACTRN12609000355279
Ethics application status
Approved
Date submitted
29/04/2009
Date registered
25/05/2009
Date last updated
6/12/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of intraoperative repair of the trochanteric bursa on hip function in patients undergoing total hip replacement
Scientific title
Can intraoperative repair of the trochanteric bursa improve hip pain and function in patients undergoing Total Hip Arthroplasty? A prospective randomised control study.
Secondary ID [1] 283712 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
lateral thigh pain after total hip replacement 4696 0
Condition category
Condition code
Surgery 5010 5010 0 0
Surgical techniques
Musculoskeletal 237057 237057 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients undergoing Total Hip Replacement (THR) will be asked to participate in the project. The posterior hip approach for THR involves division of trochanteric bursa, which is located superficially to the muscles and joint capsule. After completion of the hip replacement and closure of capsule and muscles, the bursa will be either resected (Group A) or preserved and repaired (Group B). Both procedures take less than 5 min and constitute a routine step of wound closure. In Group A the trochanteric bursa, which is routinely dissected during the posterior hip approach, will be simply excised. In Group B, the divided tissue will be repaired by using absorbable sutures. During the postoperative period and at the time of routine follow-up examination for THR, the patients will be asked if they have lateral thigh pain or if they can effectively lie on the operated side. Furthermore, a general functional hip score (Harris Hip Score) will be also evaluated. The collected data will be afterwards analysed. According to the result, the null hypothesis will be confirmed or rejected and an evidence-based conclusion regarding the role of trochanteric bursa in THR will be extracted.
Intervention code [1] 4457 0
Treatment: Surgery
Comparator / control treatment
Patients with resection of trochanteric bursa (Group A)
Control group
Active

Outcomes
Primary outcome [1] 5898 0
Lateral thigh pain. This will be estimated by using a visual analogue scale (VAS) pain score ranging from 0 (no pain) to 10 (unbearable pain).
Timepoint [1] 5898 0
1 week, 6 weeks, 3 months, 6 months, 12 months and 24 months after completion of procedure.
Secondary outcome [1] 241943 0
Hip range of motion. This includes hip flexion, extension, abduction, adduction, internal and external rotation. A standard goniometer will be used to obtain all joint angle measurements.
Timepoint [1] 241943 0
1 week, 6 weeks, 3 months, 6 months, 12 months and 24 months after completion of procedure.

Eligibility
Key inclusion criteria
Patients with primary non-inflammatory hip osteoarthritis
Minimum age
40 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous surgical interventions in the ipsilateral hip and thigh, chronic low back pain, malignancy, inflammatory arthritis, ,metabolic diseases.

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 5016 0
Self funded/Unfunded
Name [1] 5016 0
Study is totally unfunded and is performed only for scientific reasons. No individual(s) or organisation(s) will provide any funding during the study.
Address [1] 5016 0
Country [1] 5016 0
Primary sponsor type
Individual
Name
Byron Chalidis
Address
Malabar Orthopaedic Clinic, 43 The Avenue, Windsor 3181, Melbourne, VIC
Country
Australia
Secondary sponsor category [1] 4409 0
None
Name [1] 4409 0
Address [1] 4409 0
Country [1] 4409 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6941 0
Avenue Hospital
Ethics committee address [1] 6941 0
40 The Avenue, Windsor Victoria 3181
Ethics committee country [1] 6941 0
Australia
Date submitted for ethics approval [1] 6941 0
21/04/2009
Approval date [1] 6941 0
30/06/2009
Ethics approval number [1] 6941 0
104

Summary
Brief summary
The trochanteric bursa is an anatomic element, which is usually divided during the commonly used posterolateral hip approaches in Total Hip Arthroplasty. So far, very little attention has been paid in the role of its preservation in major hip surgical interventions. Some surgeons prefer to simply resect the bursa as they believe that may be responsible for lateral thigh pain. Other surgeons advocate that preservation of the tissue may add a “protection” layer to the hip joint. The purpose of the study is to compare the clinical results of either resecting or repairing the trochanteric bursa after Total Hip Arthroplasty. Therefore, the tissue will be resected in half of patients and repaired in the other half. The patients will be evaluated in terms of lateral thigh pain and hip mobility. A comparison will be made in each group between the preoperative period and serial time points at the postoperative period. The two groups will be also compared each other.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29548 0
Mr Stephen McMahon
Address 29548 0
Malabar Orthopaedic Clinic, 43 The Avenue, Windsor 3181, Melbourne, VIC
Country 29548 0
Australia
Phone 29548 0
+61 3 9510 7766
Fax 29548 0
Email 29548 0
steve.mcmahon@joint-replacements.com
Contact person for public queries
Name 12795 0
Mr Mr Stephen McMahon
Address 12795 0
Malabar Orthopaedic Clinic, 43 The Avenue, Windsor 3181, Melbourne, VIC
Country 12795 0
Australia
Phone 12795 0
+61 3 9510 7766
Fax 12795 0
Email 12795 0
steve.mcmahon@joint-replacements.com
Contact person for scientific queries
Name 3723 0
Mr Mr Byron Chalidis
Address 3723 0
Malabar Orthopaedic Clinic, 43 The Avenue, Windsor 3181, Melbourne, VIC
Country 3723 0
Australia
Phone 3723 0
+61 3 9510 7766
Fax 3723 0
Email 3723 0
byronchalidis@gmail.com (No other email account is available)

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary