Clinical Outcome Study for the Triathlon Cruciate Retaining (CR) Total Knee (TriathlonCR)

Clinical Outcome Study for the Triathlon CR Total Knee

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

Study Overview

• Status: Completed
• Conditions: Total Knee Arthroplasty
• Intervention / Treatment: Device: Triathlon CR Total Knee System

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 168
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Roskilde
    • Koge, Roskilde, Denmark, 4600
      • Koge Sygehus
• Finland
  • Westfinland
    • Turku, Westfinland, Finland, 20521
      • Hospital District of South West Finland
• Germany
  • Baden-Württemberg
    • Baden-Baden, Baden-Württemberg, Germany, 76530
      • DRK Klinik Baden-Baden
  • Niedersachsen
    • Hannover, Niedersachsen, Germany, 30625
      • Medizinische Universität Hannover
• Spain
  • Barcelona, Spain, CP08003
    • Instituto Municipal de Asistencia Sanitaria
  • Andalusia
    • Marbella, Andalusia, Spain, 24156005 W
      • Hospital Costa del Sol

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Triathlon CR Total Knee System; Primary total knee replacement	Device: Triathlon CR Total Knee System; Primary total knee replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Triathlon CR Active Range of Motion (ROM)	Comparison of the active ROM values for patients receiving the Triathlon CR Total Knee System with historical active ROM values of the Scorpio CR Total Knee System, a control group by literature review at 2 years post Total Knee Arthroplasty. See Chaudhary R, et al 2008 JBJS included for historical control data.	2 years follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigation of Patient Outcome With Radiographic Analysis	Plain radiographs will be obtained for assessment of fixation of the device.	Pre-operative, 3 months, 1, 2 and 5 years follow-up
Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS)	The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, Range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as "excellent," "good," "fair," or "poor," a higher value represents a better outcome.	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	The SF-12 Health Survey is a 12-item patient completed questionnaire to measure general health and well-being. It includes a physical (PSC) and mental status component (MCS) score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.	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	The WOMAC collects information specific to osteoarthritis outcomes. The questionnaire uses a visual analog scale for pain, measuring factors of general pain, stiffness, and physical findings. Pain is scored from 0 to 100 for each set of factors, with 0 indicating no pain and 100 indicating extreme pain. Total WOMAC scores range from 0 to 300. Lower values represent better outcomes.	Pre-operative, 3 months, 1, 2, 3, 4 and 5 years follow-up

Collaborators and Investigators

• Sponsor: Stryker Orthopaedics
• Investigators: Principal Investigator: Christina Stukenborg-Colsman, Prof., Medizinische Universität Hannover

Publications and helpful links

General Publications

• Chaudhary R, Beaupre LA, Johnston DW. Knee range of motion during the first two years after use of posterior cruciate-stabilizing or posterior cruciate-retaining total knee prostheses. A randomized clinical trial. J Bone Joint Surg Am. 2008 Dec;90(12):2579-86. doi: 10.2106/JBJS.G.00995.

Study record dates

Study Major Dates

• Study Start: October 1, 2006
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: August 21, 2015
• First Submitted That Met QC Criteria: August 26, 2015
• First Posted (Estimated): August 31, 2015

Study Record Updates

• Last Update Posted (Actual): February 22, 2024
• Last Update Submitted That Met QC Criteria: February 20, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Arthroplasty; Knee Replacement
• Other Study ID Numbers: K-S-016