NCT00436982CompletedNot Applicable
Evaluation of Triathlon - a New Total Knee Prosthesis System. Prospective, Comparative, Randomised, Roentgen Stereophotogrammetric Analysis (RSA) Series
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Stryker Orthopaedics
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Roentgen Stereophotogrammetric Analysis (RSA)
Study Overview
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 clinical trial.
Detailed Description
The evaluation is carried out by a prospective randomised RSA-study with Triathlon cemented knee prosthesis versus Duracon cemented knee prosthesis.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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).
Arms & Interventions
Cemented Triathlon total knee system
Active Comparator
The Triathlon total knee system is the successor of the Duracon total knee system and was observed in a prospective randomised, parallel, double-blind study.
Intervention: Cemented Triathlon total knee system (Device)
Cemented Duracon total knee system
Active Comparator
The Duracon total knee system is the predecessor of the Triathlon total knee system and was observed in a prospective randomised, parallel, double-blind study.
Intervention: Duracon total knee system (Device)
Outcomes
Primary Outcomes
Roentgen Stereophotogrammetric Analysis (RSA)
Time Frame: 2 years
To compare the maximum total point motion (MTPM) of the Triathlon and Duracon tibial components at two years assessed by means of RSA.
Secondary Outcomes
- Duration Hospital Stay(preoperative to discharge)
- Mean Operative Time(intra-operative)
- Blood Loss(intra-operative)
- Roentgen Stereophotogrammetric Analysis (RSA)(3 months, 1, 5, 7 and 10 years)
- Investigation of Clinical Performance and Patient Outcome With KSS (Knee Society Score)([Time Frame: pre-operative, 3 months, 1, 2, 5, 7 and 10 years])
- Investigation of Clinical Performance and Patient Outcome With EQ-5D Patient Questionnaire(pre-operative, 3 months, 1, 2, 5, 7 and 10 years)
- Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire(pre-operative, 3 months, 1, 2, 5, 7 and 10 years)
Investigators
Study Sites (1)
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