N/A
Completed N=60
Evaluation of Triathlon - a New Total Knee Prosthesis System - Triathlon vs. Duracon
Arthroplasty, Replacement, Knee
Source: ClinicalTrials.gov NCT00436982 ↗
Enrolled (actual)
60
Serious AEs
11.7%
Results posted
Dec 2015
Primary outcomePrimary: Roentgen Stereophotogrammetric Analysis (RSA) — 0.65; 0.81 mm
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Roentgen Stereophotogrammetric Analysis (RSA) |
0.45; 0.44; 0.6; 0.64; 0.65; 1.1 | — |
| SECONDARY Roentgen Stereophotogrammetric Analysis (RSA) |
0.45; 0.44; 0.6; 0.64; 0.65; 1.1 | — |
| SECONDARY Investigation of Clinical Performance and Patient Outcome With KSS (Knee Society Score) |
17.3; 18.3; 86.09; 86.55; 93.51; 95.43 | — |
| SECONDARY Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire |
23.75; 24.38; 51.79; 54.09; 58.48; 65.51 | — |
| SECONDARY Investigation of Clinical Performance and Patient Outcome With EQ-5D Patient Questionnaire |
0.79; 0.80; 0.76; 0.78; 0.86; 0.73 | — |
| SECONDARY Mean Operative Time |
66.47; 63.7 | — |
| SECONDARY Duration Hospital Stay |
4.9; 4.76 | — |
| SECONDARY Blood Loss |
— | — |
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT00436982). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.