Active — Not RecruitingNot Applicable

Evaluation of Triathlon - A New Total Knee Prosthesis System - RSA Triathlon Cruciate Retaining - Cemented vs. Uncemented

Sweden60 participantsStarted 2009-03

Plain-language 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.

Who can participate

Age range18 Years – 85 Years

SexALL

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Inclusion criteria

✓. Patients suffering exclusively from osteo arthritis, Stage II-V \[Ahlbäck Trauma Score, 1968 391\] 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.

What they're measuring

Assessment of fixation and stability of the Triathlon total knee prosthesis by Roentgen Stereophotogrammetric Analysis (RSA)

Timeframe: 10 years follow-up; UPDATE: time frame extended up to 15 years outcomes

Trial details

NCT IDNCT02525601

SponsorRegion Skane

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-01

View on ClinicalTrials.gov More Arthroplasty, Replacement, Knee trials