Which technique, cementing or press-fit implanting, of the tibial and femoral stem of the Legion revision total knee prosthesis provides the most primary stability?
ID
Source
Brief title
Condition
- Joint disorders
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary researchparameter is stability of the prosthesis measured with RSA,
expressed in migration of the prosthesis components.
Secondary outcome
Peri-operative data (operative time, blood loss), Knee Society Score, active
flexion, passive range of motion, VAS pain and VAS satisfaction.
Background summary
The number of revision total knee arthroplasties continues to increase annually
because of the increased number of primary total knee arthroplasties and the
increased age and activity level of the patient. Two methods can be chosen to
implant the stems of the prosthesis components into the bone: cemended or
press-fit. Up till now, it is not clear which technique yields the most stable
result on short and long term. We hypothesize that there is no difference in
stability.
Study objective
Which technique, cementing or press-fit implanting, of the tibial and femoral
stem of the Legion revision total knee prosthesis provides the most primary
stability?
Study design
The study has been set up as a prospective, blinded, randomised controlled
trial. The choice whether the stems will be placed cemented or press-fit will
be randomised.
Intervention
In patients of the first group the stems of the prosthesis will be cemented, in
the other group the stems will be placed press-fit.
Study burden and risks
There is no additional risk with regard to the experimental treatments. Both
techniques are used arbitrary nowadays. The questionnaires and physical
examinations of the knee do not bring any extra burden. The RSA radiographs
have a lower radiation dose than regular X-rays and the RSA radiographs replace
the conventional radiographs at discharge and at 6 months. The total amount of
radiation is only slightly higher than during the regular follow-up.
Hengstdal 3
Ubbergen 6522 JV
NL
Hengstdal 3
Ubbergen 6522 JV
NL
Listed location countries
Age
Inclusion criteria
- patient requires a revision of his primary total knee replacement and the Legion system with both experimental implantation techniques is indicated in this patient.
- patients is willing to consent to participate in the study by signing and dating an IRB-approved consent form.
- patient plans to be available for follow-up through five years postoperative.
- patient is in stable health and is free of or treated and stabilized for cardiac, pulmonary, hematological, or other conditions that would pose excessive operative risk.
- patient has radiologically defined Type I or Type IIa/b bone loss according to Anderson Orthopedic Research Institute Bonestock Classification.
Exclusion criteria
- patient has radiologically or per-operatively defined Type III bone loss according to Anderson Orthopedic Research Institute Bonestock Classification.
- patient has a BMI>35.
- patient has an active, local infection or systemic infection.
- patient has physical, emotional or neurological conditions that would compromise the patient's compliance with postoperative rehabilitation and follow-up.
- patient has an immunosuppressive disorder (chronic condition characterized by markedly inhibited ability to respond to antigenic stimuli).
- patient has a known sensitivity to materials in the device.
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 |
|---|---|
| CCMO | NL16352.091.07 |