N/A
Completed N=58
Evaluation of Triathlon - A New Total Knee Prosthesis System - Roentgen Stereophotogrammetric Analysis (RSA) Triathlon CR vs. PS
Arthroplasty, Replacement, Knee
Source: ClinicalTrials.gov NCT02522728 ↗
Enrolled (actual)
58
Serious AEs
8.6%
Results posted
Aug 2019
Primary outcomePrimary: Assessment of Fixation and Stability of the Triathlon Total Knee Prosthesis by Roentgen Stereophotogrammetric Analysis (RSA) — 0.68; 0.79 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 Assessment of Fixation and Stability of the Triathlon Total Knee Prosthesis by Roentgen Stereophotogrammetric Analysis (RSA) |
0.68; 0.79 | — |
| SECONDARY Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) |
20.43; 25.5; 91.88; 91.57; 95.00; 94.70 | — |
| SECONDARY Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire |
47.37; 54.66; 65.67; 66.11; 75.96; 76.19 | — |
| SECONDARY Investigation of Clinical Performance and Patient Outcome With EuroQuol-5 Dimension (EQ-5D) Patient Questionnaire |
0.88; 0.80; 0.88; 0.89; 0.85; 0.87 | — |
| SECONDARY Investigation of Patient Outcome With Radiographic Analysis |
— | — |
Eligibility Criteria
Inclusion Criteria
- Patients suffering exclusively from osteo arthritis, 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.
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 (NCT02522728). 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.