Overview

This trial is active, not recruiting.

Condition arthroplasty, replacement, knee
Treatments triathlon cr cemented, triathlon cr uncemented
Sponsor Stryker European Operations BV
Start date March 2009
End date April 2020
Trial size 60 participants
Trial identifier NCT02525601, K-S-015 Triathlon RSA _5

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Triathlon Cruciate Retaining knee with cemented fixation randomised versus Triathlon Cruciated Retaining knee with uncemented fixation. The aim with this study is to evaluate the uncemented Peri-Apatite (PA) knee fixation and migration properties versus the cemented version.
triathlon cr cemented
Implantation of Knee Prosthesis
(Active Comparator)
Triathlon Cruciate Retaining knee with cemented fixation randomised versus Triathlon Cruciated Retaining knee with uncemented fixation. The aim with this study is to evaluate the uncemented PA knee fixation and migration properties versus the cemented version.
triathlon cr uncemented
Implantation of Knee Prosthesis

Primary Outcomes

Measure
Assessment of fixation and stability of the Triathlon total knee prosthesis by Roentgen Stereophotogrammetric Analysis (RSA)
time frame: 2 years follow-up

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

Inclusion Criteria: 1. Patients suffering exclusively from osteo arthritis, Stage II-V [Ahlbäck Trauma Score, 1968 391] will be operated. 2. Patients requiring knee prosthesis, suitable for the use of Duracon and Triathlon knee system 3. 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. 4. Patients who signed the Ethics Committee approved Informed Consent Form prior to surgery. Exclusion Criteria: 1. Previous major knee surgery 2. Other significant disabling problems from the muscular-skeletal system than in the knees 3. 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). 4. Patients with active or suspected infection. 5. Patients with malignancy - active malignancy. 6. Patients with severe osteoporosis, Paget's disease, renal osteodystrophy. 7. Patients immunologically suppressed, or receiving steroids in excess of physiologic dose requirements. 8. 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. 9. Female patients planning a pregnancy during the course of the study. 10. Patients with systemic or metabolic disorders leading to progressive bone deterioration. 11. 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. 12. Patients with other severe concurrent joint involvements, which can affect their outcome. 13. 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. 14. Patients under the protection of law (e.g. guardianship).

Additional Information

Official title Evaluation of Triathlon - A New Total Knee Prosthesis System - RSA Triathlon Cruciate Retaining (CR) - Cemented vs. Uncemented
Principal investigator Sören Toksvig-Larsen, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Stryker European Operations BV.