The primary endpoint:* Compare mechanical alignment of the Vanguard Knee with Signature Guide and Vanguard Knee with conventional instrumentation.The secondary endpoints:1. Compare Oxford Knee Score at 1 year post operative of the Vanguard Knee with…
Source
Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
No registrations found.
Outcome measures
Primary outcome
* mechanical alignment
Secondary outcome
1. Oxford Knee Score at 1 year post operative.
2. American Knee Society Knee Score.
3. Radiographic evaluation at each post-operative visit.
4. Survivorship at 10 year post-operative.
Background summary
The clinical results and survival of a knee replacement depends partly on the
alignment of the prosthesis, Traditional alignment techniques rely on visual
detection of bony landmarks, which is known as unreliable. The Signature TM
guides aligns the knee prosthesis on basis of MRI scans to improve the
alignment.
Study objective
The primary endpoint:
* Compare mechanical alignment of the Vanguard Knee with Signature Guide and
Vanguard Knee with conventional instrumentation.
The secondary endpoints:
1. Compare Oxford Knee Score at 1 year post operative of the Vanguard Knee with
Signature Guide and Vanguard Knee with conventional instrumentation.
2. Compare American Knee Society Knee Score of the Vanguard Knee with Signature
Guide and Vanguard Knee with conventional instrumentation.
3. Compare Radiographic evaluation at each post-operative visit of the Vanguard
Knee with Signature Guide and Vanguard Knee with conventional instrumentation.
4. Compare Survivorship at 10 year post-operative of the Vanguard Knee with
Signature Guide and Vanguard Knee with conventional instrumentation.
Study design
This clinical trial is designed as multi-centre randomized controlled study.
The study will be conducted to compare the Signature guided surgery with the
conventional technique:
Trial group: Vanguard Knee with Signature Positioning Guides
Control group: Vanguard Knee with conventional technique
Study burden and risks
- One MRI scan
- Filing in of questionnaires (approximately 15 minutes)
- 1 standing X ray
Toermalijnring 600
3301 DB Dordrecht
NL
Toermalijnring 600
3301 DB Dordrecht
NL
Listed location countries
Age
Inclusion criteria
1. Painful and disabled knee joint resulting from Osteoarthritis, Rheumatoid Arthritis or Traumatic Arthritis where one or more compartments are involved
2. Correction of varus, valgus or post traumatic deformity
3. Need to obtain pain relief and improve function
4. Ability and willingness to follow instructions, including control of weight and activity level, and to return for follow-up evaluations
5. Good nutritional state of the patient
6. Full skeletal maturity of the patient
7. Patients are at least 18 years of age
8. Patients of either sex
9. Consent form read, understood, and signed by patient.
10. Able to obtain MRI
Exclusion criteria
1. Absolute contraindications include: infection, sepsis, osteomyelitis and a previous joint replacement.
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 |
---|---|
CCMO | NL34117.098.11 |