1: Comparing the initial and long term clinical results and survival of the Vanguard Deep Dish prosthesis with the traditional Vanguard Fixed bearing prosthesis.2: Does Joint Care improves the recovery process?
ID
Source
Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
American Knee Society Score at 2 year postoperative
Secondary outcome
Patient success at 2 year postoperative (see the definition in *Study
Definition* section).
American Knee Society Score at each postoperative visit.
Radiographic evaluation at each postoperative visit.
Adverse events.
Survivorship at 10 year postoperative.
Patient satisfaction as determined by answers to patient outcomes questionnaires
Wear using rsa
Background summary
The mobile bearing knees have the theoretical advantages of potentially
minimizing the polyethylene wear and reducing the incidence of implant
loosening, which were recognized as the major causes of failure of total knee
replacements. The aims of this study are to prove that the new device, the
Vanguard Deep Dish Rotating Platform (DD RP), is at least as effective in
clinical outcome as a widely used current design of knee replacement, the
Vanguard fixed bearing, and better in long term survivorship.
Study objective
1: Comparing the initial and long term clinical results and survival of the
Vanguard Deep Dish prosthesis with the traditional Vanguard Fixed bearing
prosthesis.
2: Does Joint Care improves the recovery process?
Study design
International, multicenter, randomised, controlled trial
Intervention
total knee replacements with either Vanguard Deep Dish rotating platform or
Vanguard fixed bearing
Study burden and risks
All patients have the standard risk for a total knee prosthesis. The clinical
results of the Vanguard Deep Dish knee are unknown, however they are expected
to be equal to the Fixed Bearing knee. The Vanguard Deep Dish is expected to
give a longer survival, however this is not clinical confirmed. The patient
will obtain the standard rehabilitation protocol. During the standard
outpatient visits (preoperatively, 6 weeks, 6 month 2,3,5,7, and 10 years
postoperatively) additional questionnaires concerning knee function and pain
will be taken.
Toermalijnring 600
3301 DB Dordrecht
NL
Toermalijnring 600
3301 DB Dordrecht
NL
Listed location countries
Age
Inclusion criteria
Patients with a pre-operative knee score of < 70.
Patients scheduled to undergo primary total knee replacement because of a painful and disabled knee joint resulting from osteoarthritis.
Ability and willingness to follow instructions and to return for follow-up evaluations.
Patients who are at least 18 years of age.
Consent form read, understood, and signed by patient.
Exclusion criteria
Infection.
Osteomyelitis.
Previous partial or total prosthetic knee replacement on the operative side.
Sepsis.
Patients who had body mass index >40
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT00753090 |
| CCMO | NL24052.096.08 |