Clinical trial NCT00966979: Triathlon® Partial Knee Replacement (PKR) Outcomes Study
Official title: A Prospective, Post-market, Multi-center Study of the Outcomes of the Triathlon® Partial Knee Resurfacing (PKR) Unicondylar Knee System
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Arthroplasty, Replacement, Knee
Keywords: Osteoarthritis, Post-traumatic arthritis
Lead sponsor: Stryker Orthopaedics
Sponsor class: INDUSTRY
First posted: 2009-08-27
Enrollment: 111
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Investigation of Clinical Performance and Patient Outcome With the Functional Knee Society Score (KSS).
timeFrame: 10 years
Secondary outcomes:
measure: 10-years Kaplan Meier Survival Analysis
timeFrame: 10-years
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Heekin Orthopaedic Institute for Research, Inc.
state: Florida
city: Egg Harbor Township
country: United States
facility: Rothman Institute
state: New Jersey
city: Buffalo
country: United States
facility: Department of Orthopaedic Surgery, Kaleida Health, Buffalo General Hospital
state: New York
city: Syracuse
country: United States
facility: Syracuse Orthopedic Specialists
state: New York
city: Media
country: United States
facility: Rothman Institute
state: Pennsylvania
city: Morrisville
country: United States
facility: Mansfield Orthopaedics
state: Vermont
city: Stollberg
country: Germany
facility: Praxisklinik Stollberg und Arthro. Zentrum GmbH
city: Alessandria
country: Italy
facility: Presidlo Ospedaliero Civile Santi Antonio e Biagio
city: Hässleholm
country: Sweden
facility: Hassleholm Sygehus Ortopaedkirurgisk afd. Esplanadgatan
Study officials:
affiliation: St. Vincent's Medical Center
name: R. David Heekin, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Praxisklinik Stollberg
name: Marco Tinius, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Presidlo Ospedaliero Civile Santi Antonio e Biagio
name: Marco Schiraldi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mansfield Orthopaedics
name: Brian Aros, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rothman Institute
name: Fabio Orozco, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Orthopaedic Surgery, Kaleida Health, Buffalo General Hospital
name: Matthew Phillips, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bonutti Clinic
name: Peter Bonutti, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hassleholm Sygehus Ortopaedkirurgisk afd.
name: Soren Toksvig-Larsen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Syracuse Orthopedic Specialists
name: Brett Greenky, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oklahoma Sports Science and Orthopaedics
name: Paul Jacob, MD
role: PRINCIPAL_INVESTIGATOR
References: