Evaluate the safety and effectiveness of four cementless Taperloc versions: Taperloc Complete Reduced Distal and Taperloc Legacy Full Profile Reduced Distal compared to Taperloc Complete Full Profile and Taperloc Legacy Full Profile in primary THA.
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint is implant stability (measured with Model-based RSA) at 2
years follow-up.
Secondary outcome
Secondary endpoints are implant stability and development (early or late
ingrowth) during the pre-defined follow-up periods, standard radiographic
parameters which include qualitative femoral and acetabular findings as well as
position of the stem and cup, clinical outcomes measured with patient reported
outcomes. Other clinical data about the procedure intraoperative/surgical data,
survivorship and adverse events will be routinely monitored.
Background summary
A model-based RSA Randomized Control Trial to evaluate the stability of the
cementless Taperloc Complete compared to cementless Taperloc Legacy in primary
THA.
Study objective
Evaluate the safety and effectiveness of four cementless Taperloc versions:
Taperloc Complete Reduced Distal and Taperloc Legacy Full Profile Reduced
Distal compared to Taperloc Complete Full Profile and Taperloc Legacy Full
Profile in primary THA.
Study design
Prospective 4 Arm Randomized Control Trial. All included patients will be
assessed preoperative and directly postoperative. Follow-up will take place at
6 weeks, 3 months, 1, 2, 5, 7 and 10 years postoperatively. Assuming the
enrolment will be completed in two years total study duration will be 12 years.
Intervention
All patients will receive a total hip prosthesis because of their invalidity
and health problems which will be monitored by model-based RSA analysis. Four
different hip prostheses will be used.
Study burden and risks
Subjects participating in the study have the same risks and benefits when not
participating in the study. The Taperloc is clinically successfully used for
thirty years. Follow-up times are standard protocol evaluations of prosthesis.
During follow-up times adapted radiological evaluation (model-based RSA) and
the tantalum beads inserted during surgery, which are necessary to perform this
type of radiological evaluation, are additional for study participants.
Bronovolaan 5
DEN HAAG 2597 AX
NL
Bronovolaan 5
DEN HAAG 2597 AX
NL
Listed location countries
Age
Inclusion criteria
- Noninflammatory degenerative joint disease including osteoarthritis, avascular necrosis and rheumatoid arthritis.
- Correction of functional deformity.
Additional inclusion criteria include:
- Male or female
- > 18 and <= 75 years of age
- Subjects willing to return for follow-up evaluations that cost a bit more time because of RSA evaluation
- Subjects able to read and understand Dutch language.
Exclusion criteria
- Any active infection, sepsis or osteomyelitis; standard contraindications for elective surgery
- Uncooperative patient or patient with neurologic disorders who are incapable of following directions
- Osteoporosis or osteomalacia as assessed during preoperative planning.
- Metabolic disorders which may impair bone formation
- Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram, which cannot be explained by other comorbidity
- Vascular insufficiency, muscular atrophy or neuromuscular disease.
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| CCMO | NL45981.098.13 |