Objective: Evaluate the safety and effectiveness of two cementless Taperloc versions (Taperloc complete versus Taperloc complete Microplasty)
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study endpoint is migration at two year measured with RSA
Secondary outcome
Secondary study parameters/endpoints are malalignment, incorrect sizing,
subsidence and intraoperative fractures, early survival of the hip prosthesis
at 2 year and Clinical performance based on the clinician based outcome (HHS
and radiological evaluation) and the patient based outcomes (HOOS, EQ5D, Oxford
Hip score, Forgotten Hip).
One site will perform migration analysis with RSA. Migration at two year will
be the primary endpoint for this sub-group.
Background summary
The Taperloc Microplasty stem and the Taperloc Complete Distal Reduced stem are
already used in the clinic for a while, but are not tested enough in direct
comparison studies. Besides these stems, a variation of the cup is used which
ability to establish bone ingrowth has not been investigated directly in a
clinical trial. This randomized clinical trial with RSA investigated the
outcomes of the surgery and the short term outcomes (until 2 years
post-operatively).
Study objective
Objective: Evaluate the safety and effectiveness of two cementless Taperloc
versions (Taperloc complete versus Taperloc complete Microplasty)
Study design
Prospective two Arm Randomized Controlledmulti-center Trial. All included
patients will be assessed preoperative and directly postoperative. Follow-up
will take place at 6 weeks or 3 months (TBD), 1 and 2 years postoperatively.
Assuming the enrolment will be completed in one year total study duration will
be 3 years.
Intervention
Two different hip prostheses with CE mark with known mid to long term follow up
clinical will be used. All patients will receive a total hip prosthesis because
of their invalidity and health problems which will be followed by clinical and
radiological evaluation.
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. The Taperloc Complete has a ODEP 10A rating (Highest rating
available) and the Taperloc Complete Microplasty has a 5A rating. Follow-up
visits are the same as standard practice in the participating hospitals.
Toermalijnring 600
Dordrecht 3316LC
NL
Toermalijnring 600
Dordrecht 3316LC
NL
Listed location countries
Age
Inclusion criteria
These are standard indications for usage of the Taperloc Complete and Taperloc Microplasty stem. ;Subjects with one of the following indications:
Non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis and rheumatoid arthritis.
Correction of functional deformity. ;Additional inclusion criteria include:
Male or female
> 18 and * 70 years of age
Subjects willing to return for follow-up evaluations.
Subjects able to read and understand Dutch language.
Exclusion criteria
Active Infection (or within 6 weeks after infection)
Sepsis
Osteomyelitis;Uncooperative patient or patient with neurologic disorders who are incapable of following directions
diagnosed Osteoporosis or Osteomalacia
Metabolic disorders which may impair bone formation
Distant foci of infections which may spread to the implant site
Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
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
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL54031.098.15 |