A randomised controlled trial to assess the effect of bone graft extender added to allograft in revision hip replacement

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN77586369

Enrollment

Registered

2003-09-12

Start date

2002-08-30

Completion date

Unknown

Last updated

2017-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgery: Revision hip replacement Surgery

Interventions

A randomised prospective clinical trial is to be set up to test the efficacy of bone graft extenders in comparison with 100% allograft (to study the effect of the addition of a synthetic bone graft ex

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients requiring revision hip arthroplasty for aseptic femoral or acebular component loosening. 2. Age less then 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). Therapeutic research.

Exclusion criteria

Exclusion criteria: Not provided at time of registration

Design outcomes

Primary

Measure	Time frame
Outcome measures include complications, clinical scores and gross radiological appearances. In addition movement of the construct at each interface will be assessed by the technique of Radio Stereometric Analysis (RSA). Study endpoints: 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.	—

Measure

Time frame

Outcome measures include complications, clinical scores and gross radiological appearances. In addition movement of the construct at each interface will be assessed by the technique of Radio Stereometric Analysis (RSA). Study endpoints: 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.

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Secondary

Measure	Time frame
Not provided at time of registration	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026