Clinical trial NCT00965146: Scorpio® Cruciate Retaining (CR) Outcomes Study
Official title: An Open Label, Post-market, Non-randomized, Multi-center Study of the Outcomes of the Scorpio® Cruciate Retaining (CR) Total Knee System
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Arthropathy of Knee
Keywords: Osteoarthritis, traumatic arthritis, avascular necrosis
Lead sponsor: Stryker Orthopaedics
Sponsor class: INDUSTRY
First posted: 2009-08-25
Enrollment: 215
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 design and functional performance of the Scorpio® Cruciate Retaining (CR) Total Knee System.

Detailed description: The study design is a prospective, multi-center clinical trial. The Scorpio® Cruciate Retaining (CR) Total Knee System is to be implanted for evaluation in this study. This device system is commercially available and is intended for cemented use.

The study group will consist of a maximum of 265 cases, requiring primary total knee replacement, and diagnosed with non-inflammatory arthritis. All subjects will be implanted with a femoral component, a tibial insert, a tibial tray and a resurfaced patella. Subjects receiving bilateral total knee replacements will represent two cases. Study participants will be recruited from 5 institutions.

Subjects will be evaluated preoperatively and at follow-up intervals of 7 wks (± 2 wks), 3 months (± 3 weeks), 6 months (optional visit), 12 months (± 2 months) and annually thereafter (± 2 months). Each subject will be followed for 15 years post-implantation.

The objectives of this study are to:

1. Evaluate the effect of system component design on functional performance.
2. Evaluate the effect of system component design by comparing postoperative functional and radiographic findings with preoperative.
3. Evaluate complications and the rates in which they occur.

Eligibility criteria: Inclusion Criteria:

1. The subject is a male or non-pregnant female between the ages of 21-80.
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. Patient has inflammatory arthritis.
2. The subject is morbidly obese, \>60% over ideal body weight for frame and height.
3. The subject has a history of total or unicompartmental reconstruction of the affected joint.
4. Patient has had a high tibial osteotomy or femoral osteotomy.
5. The subject has a neuromuscular or neurosensory deficiency, which 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 steroids in excess of normal physiological requirements.
8. The subject's bone stock is compromised by disease or infection which cannot provide adequate support and/or fixation to the prosthesis.
9. The subject has had a knee fusion to 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.
12. The subject is pregnant.

Primary outcomes:
measure: Evaluate Component Design Effect on Functional Knee Society Score and Radiographic Findings.
timeFrame: 15 years
measure: Evaluate Complication Rate.
timeFrame: 15 years
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Foundation for Musculoskeletal Research and Education
state: Arkansas
city: Indianapolis
country: United States
facility: Orthopaedic Research Foundation, Inc.
state: Indiana
city: Louisville
country: United States
facility: Jewish Physician Group
state: Kentucky
city: Dearborn
country: United States
facility: Dearborn Orthopaedics
state: Michigan
city: New York
country: United States
facility: Beth Israel Medical Center
state: New York
Study officials:
affiliation: Foundation for Musculoskeletal Research and Education
name: C. Lowry Barnes, MD
role: STUDY_CHAIR
affiliation: Dearborn Orthopaedics
name: Lawrence Morawa, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jewish Physician Group
name: Arthur Malkani, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Orthopaedic Research Foundation, Inc.
name: Frank Kolisek, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beth Israel Medical Center
name: Steven Harwin, MD
role: PRINCIPAL_INVESTIGATOR
References: