Overview

This trial is active, not recruiting.

Condition total knee arthroplasty
Treatments triathlon cr total knee system, scorpio cr total knee system
Sponsor Stryker European Operations BV
Start date October 2006
End date May 2013
Trial size 225 participants
Trial identifier NCT02535741, K-S-016

Summary

An open label, post-market, non-randomised, historical controlled, multi-centre study of the outcomes of the Triathlon Cruciate Retaining (CR) Total Knee System.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Primary total knee replacement
triathlon cr total knee system
Primary total knee replacement
(Other)
Primary total knee replacement (historical group from the literature)
scorpio cr total knee system
Primary total knee replacement

Primary Outcomes

Measure
Comparison of the active range of motion (ROM) values between Triathlon CR and active ROM values of Scorpio CR from the literature
time frame: 2 years follow-up

Secondary Outcomes

Measure
Investigation of patient outcome with radiographic analysis
time frame: Pre-operative, 3 months, 1, 2 and 5 years follow-up
Investigation of clinical performance and patient outcome with the Knee Society Score (KSS)
time frame: Pre-operative, 3 months, 1, 2, 3, 4 and 5 years follow-up
Investigation of clinical performance and patient outcome with the Short Form 12 (SF-12) patient questionnaire
time frame: Pre-operative, 3 months, 1, 2, 3, 4 and 5 years follow-up
Investigation of clinical performance and patient outcome with the Western Ontario McMaster Osteoarthritis Index (WOMAC) patient questionnaire
time frame: Pre-operative, 3 months, 1, 2, 3, 4 and 5 years follow-up

Eligibility Criteria

Male or female participants from 21 years up to 80 years old.

Inclusion Criteria: 1. Patients willing to sign the Ethic Commission approved, study specific Informed Patient Consent Form. 2. Patients willing and able to comply with scheduled postoperative clinical and radiographic evaluations and rehabilitation. 3. Male or non-pregnant female between the ages of 21-80 years of age at the time of surgery. 4. Patients requiring a primary total knee replacement. 5. Patients with a diagnosis of osteoarthritis (OA), traumatic arthritis (TA), or avascular necrosis (AVN). 6. Patients with intact collateral ligaments. Exclusion Criteria: 1. Patients with inflammatory arthritis. 2. Patients that are morbidly obese, body mass index (BMI) > 40. 3. Patients with a history of total / unicompartmental reconstruction of the affected joint. 4. Patients that have had a high tibial osteotomy or femoral osteotomy. 5. Patients with neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device. 6. Patients with a systemic or metabolic disorder leading to progressive bone deterioration. 7. Patients that are immunologically compromised, or receiving chronic steroids (>30 days duration). 8. Patients bone stock is compromised by disease or infection which cannot provide adequate support and/or fixation to the prosthesis. 9. Patients with a knee fusion to the affected joint. 10. Patients with an active or suspected latent infection in or about the knee joint. 11. Patients with a history of total joint replacement on the opposite knee within less than 1 year. 12. Patients requiring bilateral total knee replacement.

Additional Information

Official title Clinical Outcome Study for the Triathlon CR Total Knee
Principal investigator Christina Stukenborg-Colsman, Prof.
Description An open label, post-market, non-randomised, historical controlled, multi-centre study of the outcomes of the Triathlon Cruciate Retaining (CR) Total Knee System. The primary objective of this study will be to compare the active range of motion values for the Triathlon CR Total Knee System with those of the Scorpio CR Total Knee System, a historical control group. ROM values will be measured by use of a Goniometer according to the protocol. It is expected that the Triathlon CR Total Knee System group's range of motion is not 5 degrees worse or superior to the control group's range of motion at two-years.
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Stryker European Operations BV.