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

Region Skane1 site in 1 country60 target enrollmentMarch 1, 2009

ConditionsArthroplasty, Replacement, Knee

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Arthroplasty, Replacement, Knee
Sponsor: Region Skane
Enrollment: 60
Locations: 1
Primary Endpoint: Assessment of fixation and stability of the Triathlon total knee prosthesis by Roentgen Stereophotogrammetric Analysis (RSA)
Status: Active, not recruiting
Last Updated: 8 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Detailed Description

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. The evaluation is carried out by a prospective randomised RSA-study with Triathlon CR cemented vs. uncemented.

Registry

clinicaltrials.gov

Start Date

March 1, 2009

End Date

December 1, 2025

Last Updated

8 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Region Skane

Responsible Party

Sponsor

Eligibility Criteria

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.
•Female patients planning a pregnancy during the course of the study.
•Patients with systemic or metabolic disorders leading to progressive bone deterioration.

Outcomes

Primary Outcomes

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

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

Assessment of fixation and stability of the Triathlon total knee prosthesis by Roentgen Stereophotogrammetric as a predictor of late mechanical loosening.

Secondary Outcomes

Investigation of clinical performance and patient outcome with Knee Injury and Osteoarthritis Outcome Score (KOOS) patient questionnaire(pre-operative, 3 months, 1, 2, 5, 7 and 10 years; UPDATE: extended 12 and 15 years)
Investigation of patient outcome with radiographic analysis(3 months, 1, 2, 5, 7 and 10 years; UPDATE: extended 12 and 15 years)
Investigation of clinical performance and patient outcome with Knee Society Score (KSS)(pre-operative, 3 months, 1, 2, 5, 7 and 10 years; UPDATE: extended 12 and 15 years)
Investigation of clinical performance and patient outcome with EuroQuol-5 dimension (EQ-5D) patient questionnaire(pre-operative, 3 months, 1, 2, 5, 7 and 10 years; UPDATE: extended 12 and 15 years)