REVISION HIP REPLACEMENT MedDRA version: 9.1 Level: LLT Classification code 10057128 Term: Revision of hip arthroplasty
Conditions
Interventions
Trade Name: OSIGRAFT
Pharmaceutical Form: Powder for suspension for injection
INN or Proposed INN: EPTOTERMIN ALFA
Other descriptive name: OSIGRAFT
Concentration unit: mg milligram(s)
Concentration t
Sponsors
GREATER GLASGOW HEALTH BOARD
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 REQUIRE REVISION HIP REPLACEMENT SURGERY WITH A LOOSE ACETABULAR COMPONENT AND BONE DEFICIENCY VISIBLE ON X-RAY. 2 REQUIRE BONE GRAFTING AS PART OF THE REVISION HIP REPLACEMENT OPERATION. 3 LIKELY TO BE ABLE TO WEIGHT BEAR AND WALK IN THE IMMEDIATE POST OPERATIVE PHASE. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1 PATIENTS WHO DO NOT AGREE TO CONSENT 2 PATIENTS WHO RE UNABLE TO WEIGHT BEAR POST OP. ( EG RELATED TO THE NATURE OF ANY FEMORAL REVISION ) 3 PATIENTS IN WHOM OSIGRAFT IS CONTRAINDICATED AS PER THE MANUFACTURERS GUIDELINES
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: DURING REVISION HIP REPLACEMENT SURGERY OPERATIONS IT IS COMMON PRACTICE TO USE BONE GRAFT (FRESH FROZEN ALLOGRAFT - DONATED BY OTHER PATIENTS HAVING HIP REPLACEMENT SURGERY ) TO BUILD UP DEFECTS IN THE HIP SOCKET IN ORDER TO PROVIDE GOOD SUPPORT FOR THE NEW INPLANT. WE WISH TO DETERMINE IF MATERIAL OTHER THAN FRESH FROZEN ALLOGRAFT BONE WILL PROVIDE SIMILAR LEVELS OF SUPPORT. WE PLAN TO COMPARE FRESH FROZEN ALLOGRAFT BONE TO A MIXTURE OF MARROW - DEPLETED BONE ( ALSO DONATED BY OTHER PATIENTS HAVING HIP REPLACEMENTS BUT PREPARED BY THE SCOTTISH BLOOD TRANSFUSION SERVICES BONE BANK IN A DIFFERENT MANNER ) AND A SYNTHETIC BONE SUBSTITUTE ( BONESAVE - CALCIUM PHOSPHATE GRANULES ) PLUS OR MINUS A BONE MORPHOGENIC PROTEIN ( OSIGRAFT - A PROTEIN WHICH INDUCES NEW BONE FORMATION ).;Secondary Objective: NONE;Primary end point(s): RADIOSTEREOMETRIC X-RAYS WILL BE TAKEN OF THE HIP REPLACEMENTS AT 2-3 DAYS, 3 MTHS, 6 MTHS, 1 YR AND 2 YRS POST OPERATIVELY. | — |
Countries
United Kingdom
Outcome results
None listed