Condition category
Surgery
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
22/09/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr John Timperley

ORCID ID

Contact details

Royal Devon & Exeter Hospital (Wonford)
Barrack Road
Exeter
Devon
EX2 5BW
United Kingdom
+44 (0)1392 403544

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0203096531

Study information

Scientific title

Acronym

Study hypothesis

Does the use of washed morcellised allograft in revision surgery of the femoral component of a total hip replacement improve the clinical or radiological result when compared with the use of unwashed material?

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Surgery: revision hip replacement

Intervention

Initial patient selection followed by consent to be included in trial. Randomisation by sealed envelope in theatre when condition of femur established and operative procedure decided upon. Tantalum balls to be inserted into femur. Adapted radiostereometric analysis (RSA) Exeter stems and distal plugs to be implanted.
Beads to be inserted in cement and in graft. Post-op RSA and plain X-rays. Routine Exeter post-op mobilization protocol to be followed. Routine follow-up at 6 weeks, 6 months, 1 year and then yearly for 5 years (this is the routine follow-up protocol). RSA films to be taken at each appointment. Routine standard anteroposterior (A-P) films to be taken bi-annually. Dual energy X-ray absortiometry (DEXA) scan to be repeated at each routine post-op appointment until completion of trial.

Intervention type

Procedure/Surgery

Phase

Not Applicable

Drug names

Primary outcome measures

To conduct a randomised trial to study the effect of washing the allograft bone used in impaction grafting at revision hip arthroplasty. Patients undergoing revision hip surgery will be randomised into two groups at the time of their operation. An identical surgical procedure will be carried out except that one group will have the morcellised allograft washed and the other group will have unwashed graft used as is the present practice. The patients will be followed up for 5 years.

Outcome measures include complications, clinical scores, bone healing as quantified on DEXA scanning and gross radiological appearances. In addition, movement of the construct at each interface will be assessed by the technique of RSA.

Study end points: life tables and survival curves with confidence limits for different definitions of failure including implant loosening and radiological evidence of failure including implant migration (as defined by RSA), excessive wear, radiolucencies, etc. Log rank comparison.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

04/06/2001

Overall trial end date

30/06/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients requiring revision hip arthroplasty for aseptic femoral component loosening
2. Age less than 85
3. Femoral bone stock loss equivalent to Endoklinik 2 or 3 (loss of cancellous bone in the proximal femur, possible parosteal increase in dimension but essentially a cavitary defect only with no need for reconstruction meshes or long stems).

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

04/06/2001

Recruitment end date

30/06/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Devon & Exeter Hospital (Wonford)
Exeter, Devon
EX2 5BW
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

Royal Devon and Exeter NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes