Scorpio® Cruciate Retaining (CR) Outcomes Study

Arthropathy of Knee Clinical Trial

Official title:

An Open Label, Post-market, Non-randomized, Multi-center Study of the Outcomes of the Scorpio® Cruciate Retaining (CR) Total Knee System

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00965146
• Other study ID #: 48
• Status: Terminated
• Phase: N/A
• First received: August 11, 2009
• Last updated: October 16, 2017
• Start date: June 2001

Study information

• Verified date: April 2013
• Source: Stryker Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the design and functional performance of the Scorpio® Cruciate Retaining (CR) Total Knee System.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 215
• Est. primary completion date: July 23, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthropathy of Knee
• Joint Diseases

Intervention

Device:
• Scorpio® CR Total Knee System
All subjects will be implanted with a femoral component, a tibial insert, a tibial tray and a resurfaced patella.

Locations

Country	Name	City	State
United States	Dearborn Orthopaedics	Dearborn	Michigan
United States	Orthopaedic Research Foundation, Inc.	Indianapolis	Indiana
United States	Foundation for Musculoskeletal Research and Education	Little Rock	Arkansas
United States	Jewish Physician Group	Louisville	Kentucky
United States	Beth Israel Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Stryker Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate Component Design Effect on Functional Knee Society Score and Radiographic Findings.	This study was terminated prior to the protocol defined 15 year endpoint. As such, final outcome measures cannot be posted.	15 years
Primary	Evaluate Complication Rate.	This study was terminated prior to the protocol defined 15 year endpoint. As such, final outcome measures cannot be posted.	15 years