Triathlon® Partial Knee Replacement (PKR) Outcomes Study

NCT00966979 | Terminated Results

• 1 other identifier: 66
• Study Type: interventional
• Target: 111
• Locations: 4 countries
• Sites: 9

Brief Summary

The purpose of this study is to compare the 10-year Knee Society Score (KSS) functional results of the Triathlon PKR Unicondylar Knee to the 10-year Knee Society Score (KSS) functional results of the Triathlon Cruciate Retaining (CR) Total Knee.

Conditions

Arthroplasty, Replacement, Knee

Keywords

Osteoarthritis, Post-traumatic arthritis

Outcome Measures

Primary Outcomes (1)

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

  The Knee Society Score (KSS) consists of two distinct sub-scores: one for pain, range of motion, joint stability and alignment (Pain/Motion KSS) and one for distance walked, stair climbing and walking aids (Functional KSS). This outcome measure was only for the KSS Function Score at 10-years. The KSS Function score subscale is 0-100, with 100 representing a better outcome. Although the specific scores are not distinguished as "excellent", "good", "fair", or "poor", a higher value represents a better outcome.

  10 years

Secondary Outcomes (1)

• 10-years Kaplan Meier Survival Analysis

  10-years

Study Arms (1)

Triathlon PKR

OTHER

All subjects enrolled will receive the Triathlon PKR device.

Device: Triathlon PKR

Interventions

Triathlon PKR DEVICE

Triathlon PKR is a unicondylar knee resurfacing system designed to replace a single osteoarthritic compartment of a patient's natural knee.

Triathlon PKR

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject is a male or non-pregnant female 21-75 years of age at the time of enrollment.
• The subject requires a primary cemented unicompartmental knee replacement.
• The subject has a diagnosis of osteoarthritis (OA) or posttraumatic arthritis (TA).
• The subject has clinically intact cruciate and collateral ligaments and no ligamentous instability is present.
• The subject has less than 10 degrees of flexion contracture and greater than 90 degrees of flexion.
• The subject's preoperative mechanical alignment is less than 15 degrees of varus and 15 degrees of valgus.
• The subject has signed the Institutional Review Board (IRB) approved study specific Informed Patient Consent Form.
• The subject is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.

You may not qualify if:

• The subject has inflammatory arthritis or avascular necrosis(AVN).
• The subject is obese, BMI \> 35.
• The subject has a history of total or unicompartmental (contralateral compartment and/or patellofemoral joint) reconstruction of the affected joint.
• The subject has a history of anterior cruciate ligament (ACL) reconstruction.
• The subject has had a high distal femoral, or proximal tibial osteotomy.
• The subject has a mental, neuromuscular or neurosensory disorder, which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in post-operative care and/or limit the ability to assess the performance of the device.
• The subject has a systemic or metabolic disorder leading to progressive bone deterioration that the surgeon feels would affect the overall outcome of the study.
• The subject is immunologically suppressed, or is receiving chronic steroids (\>30 days duration).
• The subject has a known sensitivity to device materials.
• The subject's bone stock is compromised by disease and/or infection which cannot provide adequate support and/or fixation to the prosthesis.
• The subject's bone stock is compromised by a prior implantation which cannot provide adequate support and/or fixation to the prosthesis.
• The subject has an active or suspected latent infection in or about the knee joint.
• The subject is a prisoner.

Sponsors & Collaborators

• Stryker Orthopaedics: lead

Study Sites (9)

Heekin Orthopaedic Institute for Research, Inc.

Jacksonville, Florida, 32204, United States

Location

Rothman Institute

Egg Harbor, New Jersey, 08234, United States

Location

Department of Orthopaedic Surgery, Kaleida Health, Buffalo General Hospital

Buffalo, New York, 14203, United States

Location

Syracuse Orthopedic Specialists

Syracuse, New York, 13214, United States

Location

Rothman Institute

Media, Pennsylvania, 19063, United States

Location

Mansfield Orthopaedics

Morrisville, Vermont, 05661, United States

Location

Praxisklinik Stollberg und Arthro. Zentrum GmbH

Stollberg, 09366, Germany

Location

Presidlo Ospedaliero Civile Santi Antonio e Biagio

Alessandria, 15100, Italy

Location

Hassleholm Sygehus Ortopaedkirurgisk afd. Esplanadgatan

Hässleholm, Sweden

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Limitations and Caveats

After 13-years the enrollment goal was not met. This led to a protocol amendment to include retrospective cases. These cases were combined with the initial prospective cases and followed prospectively for the planned observation time. This study does not compare prospective to retrospective cases. The retrospectively enrolled cases were followed prospectively and there were no retrospective cases that reached the 10-year time point, only 12 prospective cases had 10-year data.

Results Point of Contact

• Title: Stryker JR Clinical Research
• Organization: Stryker Orthopaedics

StrykerJRClinical@stryker.com

201-831-5000

Study Officials

• R. David Heekin, M.D.

  St. Vincent's Medical Center

  PRINCIPAL INVESTIGATOR

• Marco Tinius, MD

  Praxisklinik Stollberg

  PRINCIPAL INVESTIGATOR

• Marco Schiraldi, MD

  Presidlo Ospedaliero Civile Santi Antonio e Biagio

  PRINCIPAL INVESTIGATOR

• Brian Aros, MD

  Mansfield Orthopaedics

  PRINCIPAL INVESTIGATOR

• Fabio Orozco, MD

  Rothman Institute

  PRINCIPAL INVESTIGATOR

• Matthew Phillips, MD

  Department of Orthopaedic Surgery, Kaleida Health, Buffalo General Hospital

  PRINCIPAL INVESTIGATOR

• Peter Bonutti, MD

  Bonutti Clinic

  PRINCIPAL INVESTIGATOR

• Soren Toksvig-Larsen, MD

  Hassleholm Sygehus Ortopaedkirurgisk afd.

  PRINCIPAL INVESTIGATOR

• Brett Greenky, MD

  Syracuse Orthopedic Specialists

  PRINCIPAL INVESTIGATOR

• Paul Jacob, MD

  Oklahoma Sports Science and Orthopaedics

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• 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 25, 2009
• First Posted: August 27, 2009
• Study Start: January 1, 2010
• Primary Completion: September 1, 2022
• Study Completion: May 1, 2023
• Last Updated: September 13, 2023
• Results First Posted: September 13, 2023

Record last verified: 2023-08

Locations

SE (1); US (6); IT (1); DE (1)