ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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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]

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

Condition category

Condition code

Surgery

Surgical techniques

Musculoskeletal

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]

Treatment: Surgery

Comparator / control treatment

Patients with resection of trochanteric bursa (Group A)

Control group

Active

Outcomes

Primary outcome [1]

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]

1 week, 6 weeks, 3 months, 6 months, 12 months and 24 months after completion of procedure.

Secondary outcome [1]

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]

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

Sex

Both males and females

Can healthy volunteers participate?

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

10/05/2009

Actual

21/09/2009

Date of last participant enrolment

Anticipated

25/10/2010

Actual

25/10/2010

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]

Self funded/Unfunded

Name [1]

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]

Country [1]

Primary sponsor type

Individual

Name

Byron Chalidis

Address

Malabar Orthopaedic Clinic, 43 The Avenue, Windsor 3181, Melbourne, VIC

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Avenue Hospital

Ethics committee address [1]

40 The Avenue, Windsor Victoria 3181

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

21/04/2009

Approval date [1]

30/06/2009

Ethics approval number [1]

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

Mr Stephen McMahon

Address

Malabar Orthopaedic Clinic, 43 The Avenue, Windsor 3181, Melbourne, VIC

Country

Australia

Phone

+61 3 9510 7766

Fax

steve.mcmahon@joint-replacements.com

Contact person for public queries

Name

Mr Stephen McMahon

Address

Malabar Orthopaedic Clinic, 43 The Avenue, Windsor 3181, Melbourne, VIC

Country

Australia

Phone

+61 3 9510 7766

Fax

steve.mcmahon@joint-replacements.com

Contact person for scientific queries

Name

Mr Byron Chalidis

Address

Malabar Orthopaedic Clinic, 43 The Avenue, Windsor 3181, Melbourne, VIC

Country

Australia

Phone

+61 3 9510 7766

Fax

byronchalidis@gmail.com (No other email account is available)

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

Source	Title	Year of Publication	DOI
Embase	Lateral trochanteric bursa repair improves early hip function after posterior approach total hip arthroplasty: a prospective randomized control trial.	2022	https://dx.doi.org/10.1186/s42836-022-00127-6

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically