Status:
COMPLETED
Evaluation of Triathlon - a New Total Knee Prosthesis System - Triathlon vs. Duracon
Lead Sponsor:
Stryker Orthopaedics
Conditions:
Arthroplasty, Replacement, Knee
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
The objective is to investigate the Clinical, Radiographic, Roentgen Stereophotogrammetric behaviour and patient outcome when using the Triathlon total knee prosthesis in a prospective randomized clin...
Detailed Description
The evaluation is carried out by a prospective randomised RSA-study with Triathlon cemented knee prosthesis versus Duracon cemented knee prosthesis.
Eligibility Criteria
Inclusion
- Patients suffering exclusively from osteo arthritis (OA), Stage II-V \[Ahlbäck, 1968\] will be operated.
- Patients requiring knee prosthesis, suitable for the use of Duracon and Triathlon knee system
- Patients who understand the conditions of the study and are willing and able to comply with the post-operative scheduled clinical and radiographical evaluations and the prescribed rehabilitation.
- Patients who signed the Ethics Committee approved Informed Consent Form prior to surgery.
Exclusion
- Previous major knee surgery
- Other significant disabling problems from the muscular-skeletal system than in the knees
- Obese patients where obesity is severe enough to affect subject's ability to perform activities of daily living (body mass index, kg/m2: BMI above 35).
- Patients with active or suspected infection.
- Patients with malignancy - active malignancy.
- Patients with severe osteoporosis, Paget's disease, renal osteodystrophy.
- Patients immunologically suppressed, or receiving steroids in excess of physiologic dose requirements.
- The patient has a neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device or the patient has a neurological deficit which interferes with the patient's ability to limit weight bearing or places an extreme load on the implant during the healing period.
- Female patients planning a pregnancy during the course of the study.
- Patients with systemic or metabolic disorders leading to progressive bone deterioration.
- Patients, who as judged by the surgeon, are mentally incompetent or are unlikely to be compliant with the prescribed post-operative routine and follow-up evaluation schedule.
- Patients with other severe concurrent joint involvements, which can affect their outcome.
- Patients with other concurrent illnesses, which are likely to affect their outcome such as sickle cell anaemia, systemic lupus erythematosus or renal disease requiring dialysis.
- Patients under the protection of law (e.g. guardianship).
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 4 2017
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00436982
Start Date
February 1 2006
End Date
January 4 2017
Last Update
February 22 2024
Active Locations (1)
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1
Hässleholm Hospital
Hässleholm, Sweden