Primary goal: mean linear wear of the cross-linked polyethylene F.A.L. cup compared to the mean linear wear of the standard polyethylene F.A.L. cup at 5 years postoperatively. Secondary goals:1. mean linear wear (millimeters/year) at 1 year, 3 years…
ID
Source
Brief title
Condition
- Joint disorders
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Mean linear wear of the cross-linked polyethylene F.A.L. cup compared to the
mean linear wear of the standard polyethylene F.A.L. cup at 5 years
postoperatively.
Secondary outcome
1. mean linear wear (millimeters/year) at 1 year, 3 years and 10 years
postoperatively
2. patient reported outcome measures (HOOS-PS, Oxford Hip Score, pain score,
EQ5D and the SQUASH) at 1 year, 3 years 5 years and 10 years postoperatively
3. number of periprosthetic radiolucencies at 5 years and 10 years
postoperatively
4. survival of the implant at 5 years and 10 years postoperatively
5. total inpatient costs 10 years postoperatively
Background summary
Aseptic loosening is the most common reason for the failure of a total hip
replacement and subsequent revision surgery. Histological and in vitro studies
have shown that polyethylene wear particles can play an important role in the
loosening process of the implant. A higher wear resistance of polyethylene can
be achieved by cross-linking, that is obtained when the polyethylene is
irradiated with gamma rays. Wear simulation studies and clinical studies have
shown that the wear of cross-linked polyethylene acetabular cups significantly
decreases compared to standard polethylene.
The F.A.L. ® acetabular cup (Link, Hamburg, Germany) is, in addition to the
standard polyethylene cup, also available in a cross-linked polyethylene
version. Because producers of cross-linked polyethylene maintain own production
methods with different radiation protocols, there is no standardized 'standard
' or 'cross-linked' polyethylene and are the results of the various cups not
interchangeable or generalizable.
The F.A..L. cup with standard polyethylene has good wear results and an
excellent survival rate. The question is whether this can be improved by the
cross-linked variant.
The hypothesis of this study is that the mean linear wear rate of the
cross-linked polyethylene F.A.L. cup is significantly less than the mean
linear wear of the standard polyethylene F.A.L. cup in the general patient
population with symptomatic coxarthrosis and an indication for a cemented hip
replacement.
Study objective
Primary goal: mean linear wear of the cross-linked polyethylene F.A.L. cup
compared to the mean linear wear of the standard polyethylene F.A.L. cup at 5
years postoperatively.
Secondary goals:
1. mean linear wear (millimeters/year) at 1 year, 3 years and 10 years
postoperatively
2. patient reported outcome measures (HOOS-PS, Oxford Hip Score, pain score,
EQ5D and the SQUASH) at 1 year, 3 years 5 years and 10 years postoperatively
3. number of periprosthetic radiolucencies at 5 years and 10 years
postoperatively
4. survival of the implant at 5 years and 10 years postoperatively
5. total inpatient costs 10 years postoperatively
Study design
A prospective, randomized clinical trial comparing two types of polyethylene
(crosslinked versus standard) acetabular cups with similar design.
Intervention
Patients will receive a cemented total hip arthroplasty: F.A.L. cup and SPII
stem
Group 1: crosslinked polyethylene F.A.L. cup and SPII stem
Group 2: standard polyethylene F.A.L. cup and SPII stem
Study burden and risks
The visits, including making standard x-rays and filling in questionnaires,at 6
weeks, 3 months, 1 year, 5 years and 10 years postoperatively are part of usual
care, with the exception of the SQUASH.
The consultation (interview and physical examination) at the orthopaedic
surgeon and the x-rays will take about 20 minutes. Filling in the
questionnaires costs about 15 minutes.
The visit preoperatively to the researcher and postoperatively to the
orthopepaedic at 3 years are extra for the F.A.L. cup trial.
Since the F.A.L. cup is already applied extensively, there are for this study
no additional risks expected other than the general risks as associated with a
cemented total hip replacement.
Henri Dunantweg 2
Leeuwarden 8934 AD
NL
Henri Dunantweg 2
Leeuwarden 8934 AD
NL
Listed location countries
Age
Inclusion criteria
1. Age 65 - 80 years
2. Symptomatic coxarthrosis and an indication for a cemented total hip prothesis
3. Physically and mentally able to attend the postoperative follow-up evaluations
4. Signed informed consent form
Exclusion criteria
1. Standard contraindications to elective (un)cemented total hip athroplasties
2. Neurological disorders that affect walking
3. Physical or mental disabilities that could affect judgment or filling out the questionnaires
4. Not literate in Dutch
5. Body Mass Index > 40
6. An abnormal hip anatomy because of which the F.A.L. cup and SPII stem cannot be placed
7. Amputation of het lower extremity
8. Malignancies and currently receiving cytostatic therapy
9. Participation in another study that conflicts with the F.A.L.cup trial
10. Addiction to drugs or alcohol
11. Cup inclination of > 55 degrees
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL46774.099.13 |
| OMON | NL-OMON22863 |