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

NCT ID: NCT02535741

Last Updated: 2024-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 168 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2016-05-31

Brief 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.

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.

Conditions

Total Knee Arthroplasty

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Triathlon CR Total Knee System

Primary total knee replacement

Group Type: OTHER

Triathlon CR Total Knee System

Intervention Type: DEVICE

Primary total knee replacement

Interventions

Triathlon CR Total Knee System

Primary total knee replacement

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stryker Orthopaedics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christina Stukenborg-Colsman, Prof.

Role: PRINCIPAL_INVESTIGATOR

Medizinische Universität Hannover

Locations

Koge Sygehus

Køge, Roskilde, Denmark

Hospital District of South West Finland

Turku, Westfinland, Finland

DRK Klinik Baden-Baden

Baden-Baden, Baden-Wurttemberg, Germany

Medizinische Universität Hannover

Hanover, Lower Saxony, Germany

Hospital Costa del Sol

Marbella, Andalusia, Spain

Instituto Municipal de Asistencia Sanitaria

Barcelona, , Spain

Countries

Denmark; Finland; Germany; Spain

References

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.

Reference Type: BACKGROUND

PMID: 19047702 (View on PubMed)

Other Identifiers

K-S-016

Identifier Type: -

Identifier Source: org_study_id