Overview

This trial is active, not recruiting.

Condition arthroplasty, replacement, knee
Treatments triathlon standard keel, triathlon short keel
Sponsor Stryker European Operations BV
Start date February 2008
End date November 2018
Trial size 59 participants
Trial identifier NCT02525614, K-S-015 Triathlon RSA _4

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 (CR) with a tibial keel of standard length randomised against Triathlon Cruciate Retaining knee (CR) with a tibial part with a short keel, both system will be used with cemented fixation. The short tibial keel is thought to facilitate the surgery due to easier access and better positioning possibilities. This study is aimed to evaluate if the short tibial keel will have equal fixation and migration properties as the standard keel.
triathlon standard keel
Implantation of Knee Prosthesis
(Active Comparator)
Triathlon Cruciate Retaining knee (CR) with a tibial keel of standard length randomised against Triathlon Cruciate Retaining knee (CR) with a tibial part with a short keel, both system will be used with cemented fixation. The short tibial keel is thought to facilitate the surgery due to easier access and better positioning possibilities. This study is aimed to evaluate if the short tibial keel will have equal fixation and migration properties as the standard keel.
triathlon short keel
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 KSS (Knee Society Score)
time frame: pre-operative, 3 months, 1, 2, 5, 7 and 10 years
Investigation of clinical performance and patient outcome with KOOS patient questionnaire
time frame: pre-operative, 3 months, 1, 2, 5, 7 and 10 years
Investigation of clinical performance and patient outcome with 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 OA, Stage II-V [Ahlbäck-Traumascore, 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 Standard vs. Short Keel
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 Standard vs. Short Keel.
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Stryker European Operations BV.