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

Total Knee Arthroplasty Clinical Trial

— TriathlonCR  

Official title:

Clinical Outcome Study for the Triathlon CR Total Knee

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02535741
• Other study ID #: K-S-016
• Status: Completed
• Phase: N/A
• Start date: October 2006
• Est. completion date: May 2016

Study information

• Verified date: February 2024
• Source: Stryker Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: May 2016
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Total Knee Arthroplasty

Intervention

Device:
• Triathlon CR Total Knee System
Primary total knee replacement

Locations

Country	Name	City	State
Denmark	Koge Sygehus	Koge	Roskilde
Finland	Hospital District of South West Finland	Turku	Westfinland
Germany	DRK Klinik Baden-Baden	Baden-Baden	Baden-Württemberg
Germany	Medizinische Universität Hannover	Hannover	Niedersachsen
Spain	Instituto Municipal de Asistencia Sanitaria	Barcelona
Spain	Hospital Costa del Sol	Marbella	Andalusia

Sponsors (1)

Lead Sponsor	Collaborator
Stryker Orthopaedics

Countries where clinical trial is conducted

Denmark,  Finland,  Germany,  Spain, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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