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Scorpio® Cruciate Retaining (CR) Outcomes Study

Primary Purpose

Arthropathy of Knee

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Scorpio® CR Total Knee System

About this trial

This is an interventional treatment trial for Arthropathy of Knee focused on measuring Osteoarthritis, traumatic arthritis, avascular necrosis

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

The subject is a male or non-pregnant female between the ages of 21-80.
The subject requires a primary cemented total knee replacement.
The subject has a diagnosis of osteoarthritis (OA), traumatic arthritis (TA), or avascular necrosis (AVN).
The subject has intact collateral ligaments.
The subject has signed the 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:

Patient has inflammatory arthritis.
The subject is morbidly obese, >60% over ideal body weight for frame and height.
The subject has a history of total or unicompartmental reconstruction of the affected joint.
Patient has had a high tibial osteotomy or femoral osteotomy.
The subject has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
The subject has a systemic or metabolic disorder leading to progressive bone deterioration.
The subject is immunologically suppressed, or receiving steroids in excess of normal physiological requirements.
The subject's bone stock is compromised by disease or infection which cannot provide adequate support and/or fixation to the prosthesis.
The subject has had a knee fusion to the affected joint.
The subject has an active or suspected latent infection in or about the knee joint.
The subject is a prisoner.
The subject is pregnant.

Sites / Locations

Foundation for Musculoskeletal Research and Education
Orthopaedic Research Foundation, Inc.
Jewish Physician Group
Dearborn Orthopaedics
Beth Israel Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Scorpio® CR Total Knee System

Arm Description

Scorpio® CR Total Knee System Study Device

Outcomes

Primary Outcome Measures

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.

Evaluate Complication Rate.

This study was terminated prior to the protocol defined 15 year endpoint. As such, final outcome measures cannot be posted.

Secondary Outcome Measures

Full Information

NCT ID

NCT00965146

First Posted

August 11, 2009

Last Updated

October 16, 2017

Sponsor

Stryker Orthopaedics

1. Study Identification

Unique Protocol Identification Number

NCT00965146

Brief Title

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

2. Study Status

Record Verification Date

April 2013

Overall Recruitment Status

Terminated

Why Stopped

Terminated due to lagging follow-up.

Study Start Date

June 2001 (undefined)

Primary Completion Date

July 23, 2009 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Stryker Orthopaedics

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Arthropathy of Knee

Keywords

Osteoarthritis, traumatic arthritis, avascular necrosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

215 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Scorpio® CR Total Knee System

Arm Type

Experimental

Arm Description

Scorpio® CR Total Knee System Study Device

Intervention Type

Device

Intervention Name(s)

Scorpio® CR Total Knee System

Other Intervention Name(s)

Scorpio® Cruciate Retaining (CR) Total Knee System

Intervention Description

All subjects will be implanted with a femoral component, a tibial insert, a tibial tray and a resurfaced patella.

Primary Outcome Measure Information:

Title

Evaluate Component Design Effect on Functional Knee Society Score and Radiographic Findings.

Description

This study was terminated prior to the protocol defined 15 year endpoint. As such, final outcome measures cannot be posted.

Time Frame

15 years

Title

Evaluate Complication Rate.

Description

This study was terminated prior to the protocol defined 15 year endpoint. As such, final outcome measures cannot be posted.

Time Frame

15 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: The subject is a male or non-pregnant female between the ages of 21-80. The subject requires a primary cemented total knee replacement. The subject has a diagnosis of osteoarthritis (OA), traumatic arthritis (TA), or avascular necrosis (AVN). The subject has intact collateral ligaments. The subject has signed the 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: Patient has inflammatory arthritis. The subject is morbidly obese, >60% over ideal body weight for frame and height. The subject has a history of total or unicompartmental reconstruction of the affected joint. Patient has had a high tibial osteotomy or femoral osteotomy. The subject has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device. The subject has a systemic or metabolic disorder leading to progressive bone deterioration. The subject is immunologically suppressed, or receiving steroids in excess of normal physiological requirements. The subject's bone stock is compromised by disease or infection which cannot provide adequate support and/or fixation to the prosthesis. The subject has had a knee fusion to the affected joint. The subject has an active or suspected latent infection in or about the knee joint. The subject is a prisoner. The subject is pregnant.

Overall Study Officials: