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

NCT02535741 | Completed Results

• 1 other identifier: K-S-016
• Study Type: interventional
• Target: 168
• Locations: 4 countries
• Sites: 6

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.

Conditions

Total Knee Arthroplasty

Keywords

Knee Replacement; Arthroplasty

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Investigation of Patient Outcome With Radiographic Analysis

  Pre-operative, 3 months, 1, 2 and 5 years follow-up

• Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS)

  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

  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

  Pre-operative, 3 months, 1, 2, 3, 4 and 5 years follow-up

Study Arms (1)

Triathlon CR Total Knee System

OTHER

Primary total knee replacement

Device: Triathlon CR Total Knee System

Interventions

Triathlon CR Total Knee System DEVICE

Primary total knee replacement

Triathlon CR Total Knee System

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients willing to sign the Ethic Commission approved, study specific Informed Patient Consent Form.
• Patients willing and able to comply with scheduled postoperative clinical and radiographic evaluations and rehabilitation.
• Male or non-pregnant female between the ages of 21-80 years of age at the time of surgery.
• Patients requiring a primary total knee replacement.
• Patients with a diagnosis of osteoarthritis (OA), traumatic arthritis (TA), or avascular necrosis (AVN).
• Patients with intact collateral ligaments.

You may not qualify if:

• Patients with inflammatory arthritis.
• Patients that are morbidly obese, body mass index (BMI) \> 40.
• Patients with a history of total / unicompartmental reconstruction of the affected joint.
• Patients that have had a high tibial osteotomy or femoral osteotomy.
• Patients with neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
• Patients with a systemic or metabolic disorder leading to progressive bone deterioration.
• Patients that are immunologically compromised, or receiving chronic steroids (\>30 days duration).
• Patients bone stock is compromised by disease or infection which cannot provide adequate support and/or fixation to the prosthesis.
• Patients with a knee fusion to the affected joint.
• Patients with an active or suspected latent infection in or about the knee joint.
• Patients with a history of total joint replacement on the opposite knee within less than 1 year.
• Patients requiring bilateral total knee replacement.

Sponsors & Collaborators

• Stryker Orthopaedics: lead

Study Sites (6)

Koge Sygehus

Køge, Roskilde, 4600, Denmark

Location

Hospital District of South West Finland

Turku, Westfinland, 20521, Finland

Location

DRK Klinik Baden-Baden

Baden-Baden, Baden-Wurttemberg, 76530, Germany

Location

Medizinische Universität Hannover

Hanover, Lower Saxony, 30625, Germany

Location

Hospital Costa del Sol

Marbella, Andalusia, 24156005 W, Spain

Location

Instituto Municipal de Asistencia Sanitaria

Barcelona, CP08003, Spain

Location

Related 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.

  PMID: 19047702 BACKGROUND

Results Point of Contact

• Title: Doug McGurty
• Organization: Stryker European Operations BV

doug.mcgurty@stryker.com

+44(0)1635 500690

Study Officials

• Christina Stukenborg-Colsman, Prof.

  Medizinische Universität Hannover

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2015
• First Posted: August 31, 2015
• Study Start: October 1, 2006
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2016
• Last Updated: February 22, 2024
• Results First Posted: December 7, 2015

Record last verified: 2024-02

Locations

DE (2); ES (2); DK (1); FI (1)