Evaluation of Triathlon - a New Total Knee Prosthesis System
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2007 by Stryker Nordic.
Recruitment status was Recruiting
Information provided by:
First received: February 16, 2007
Last updated: December 6, 2007
Last verified: February 2007
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.
Total Knee Arthroplasty
Device: Triathlon Knee System
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
||Evaluation of Triathlon - a New Total Knee Prosthesis System. Prospective, Comparative, Randomised, RSA Series With 2-Years Follow-up.
Primary Outcome Measures:
- Roentgen stereophotogrammetric analysis (RSA) [ Time Frame: 3 months, 1 year, 2 years ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Plain radiographs for disease class.Clinical ass. KSS and KOOS score. Postop FU all plain radiographs for ass. of the component position. Yearly radiographic FU to assess wear, radiolucent zones and stress resorption and patella sky view projection. [ Time Frame: 3 months, 1 year, 2 years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
Device: Triathlon Knee System
|Ages Eligible for Study:
||18 Years to 85 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Patients suffering exclusively from OA, Stage II-V [Ahlbäck, 1968 391] 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.
- 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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00436982
|Hässleholm, Sweden |
|Contact: Sören Toksvig-Larsen, ass prof +46746314304 |
|Contact: Anna S Pålsson, study nurse +46451296051 |
||Sören Toksvig-Larsen, ass. prof
||Department of ortopaedics, Hässleholm Hospital
No publications provided
||Sören Toksvig-Larsen, Hässleholms hospital
History of Changes
|Other Study ID Numbers:
||20050705TRIATHLON RSA PROTOCOL
|Study First Received:
||February 16, 2007
||December 6, 2007
||Sweden: Regional Ethical Review Board
Keywords provided by Stryker Nordic:
ClinicalTrials.gov processed this record on March 06, 2014