Clinical trial NCT00957021: Triathlon® Posteriorly Stabilized (PS) Total Knee System - Outcomes Study
Official title: A Prospective, Post-market, Multi-center Study of the Outcomes of the Triathlon® Posteriorly Stabilized (PS) Total Knee System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthroplasty, Replacement, Knee
Keywords: Knee
Lead sponsor: Stryker Orthopaedics
Sponsor class: INDUSTRY
First posted: 2009-08-12
Enrollment: 409
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
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 evaluate the clinical outcomes (range of motion, pain, function, radiographic stability, and health related quality of life) of patients receiving the Triathlon® Posterior Stabilized (PS) Total Knee System. These outcomes will be evaluated using pre-operative scores and comparing them to post-operative scores in addition to being compared with cases who received the Scorpio® PS implant.

Detailed description: The Triathlon® Posteriorly Stabilized (PS) Total Knee System components are for use in cemented total knee arthroplasty for painful, disabling joint disease of the knee resulting from non-inflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or rheumatoid arthritis (excluded from this study according to protocol).

The components are designed to improve range of motion (ROM) and stability. This study serves to demonstrate that subjects have reduced pain, increased ROM and improved stability following implantation with the Triathlon® PS Total Knee System.

Eligibility criteria: Inclusion Criteria:

1. The subject is a male or non-pregnant female 21-80 years of age at the time of enrollment.
2. The subject requires a primary cemented total knee replacement.
3. The subject has a diagnosis of osteoarthritis (OA), traumatic arthritis (TA), or avascular necrosis (AVN).
4. The subject has intact collateral ligaments.
5. The subject has signed the IRB approved, study specific Informed Patient Consent Form.
6. The subject is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.

Exclusion Criteria:

1. The subject has inflammatory arthritis.
2. The subject is morbidly obese, BMI \> 40.
3. The subject has a history of total or unicompartmental reconstruction of the affected joint.
4. The subject has had a high tibial osteotomy or femoral osteotomy.
5. The subject has a neuromuscular or neurosensory deficiency that would limit the ability to assess the performance of the device.
6. The subject has a systemic or metabolic disorder leading to progressive bone deterioration.
7. The subject is immunologically suppressed, or receiving chronic steroids (\>30 days duration).
8. The subject's bone stock is compromised by disease or infection and cannot provide adequate support and/or fixation to the prosthesis.
9. The subject has had a knee fusion at the affected joint.
10. The subject has an active or suspected latent infection in or about the knee joint.
11. The subject is a prisoner.

Primary outcomes:
measure: Range of Motion
timeFrame: 2 years
Secondary outcomes:
measure: Patient Outcome Knee Society Score
timeFrame: 1,2 and 5 years
measure: Patient Outcome SF-36
timeFrame: 1,2,3,4 and 5 years
measure: Patient Outcome WOMAC
timeFrame: 5 years
measure: Patient Outcome Lower-Extremity Activity Scale
timeFrame: 1,2,3,4 and 5 years
measure: Radiographic Outcome
timeFrame: 1,2 and 5 years
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Hughston Clinic PA
state: Georgia
city: Indianapolis
country: United States
facility: Ireland Hip and Knee Surgery
state: Indiana
city: Boston
country: United States
facility: New England Baptist Hospital
state: Massachusetts
city: Boston
country: United States
facility: Pro-Sports Orthopaedics, Inc. / New England Baptist Hospital
state: Massachusetts
city: Sartell
country: United States
facility: St. Cloud Orthopaedic Associates
state: Minnesota
city: Manchester
country: United States
facility: New Hampshire Orthopaedic Surgery, PA
state: New Hampshire
city: Harrison
country: United States
facility: Specialty Orthopaedics
state: New York
city: Cincinnati
country: United States
facility: Wellington Orthopaedics & Sports Medicine
state: Ohio
city: Massillon
country: United States
facility: Tri County Orthopedic Surgeons, Inc.
state: Ohio
city: Houston
country: United States
facility: Kelsey-Seybold Clinic
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: New Hampshire Orthopaedic Surgery, PA
name: Eric R Benson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tri County Orthopedics Surgeons, Inc.
name: Daniel Moretta, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: New England Baptist Hospital
name: James Bono, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kelsey-Seybold Clinic
name: David W Edelstein, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ireland Hip and Knee Surgery
name: Philip Ireland, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Cloud Orthopaedic Associates
name: Joseph P Nessler, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Virginia
name: Quanjun Cui, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pro-Sports Orthopaedics, Inc./ New England Baptist Hospital
name: Arnold Scheller, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wellington Orthopaedics and Sports Medicine
name: Joel Sorger, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wellington Orthopaedics and Sports Medicine
name: Suresh Nayak, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hughston Clinic, PA
name: John I Waldrop, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hughston Clinic, PA
name: James McGrory, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Specialty Orthopaedics
name: Steven B Zelicof, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: