NCT00965146

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
215

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

5 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2001

Completed
8.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 23, 2009

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

August 11, 2009

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 25, 2009

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

February 15, 2013

Completed
Last Updated

November 17, 2017

Status Verified

April 1, 2013

Enrollment Period

8.1 years

First QC Date

August 11, 2009

Results QC Date

November 9, 2012

Last Update Submit

October 16, 2017

Conditions

Arthropathy of Knee

Keywords

Osteoarthritis, traumatic arthritis, avascular necrosis

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (1)

Scorpio® CR Total Knee System

EXPERIMENTAL

Scorpio® CR Total Knee System Study Device

Device: Scorpio® CR Total Knee System

Interventions

Scorpio® CR Total Knee SystemDEVICE

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

Also known as: Scorpio® Cruciate Retaining (CR) Total Knee System
Scorpio® CR Total Knee System

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Foundation for Musculoskeletal Research and Education

Little Rock, Arkansas, 72205, United States

Location

Orthopaedic Research Foundation, Inc.

Indianapolis, Indiana, 46237, United States

Location

Jewish Physician Group

Louisville, Kentucky, 40202, United States

Location

Dearborn Orthopaedics

Dearborn, Michigan, 48124, United States

Location

Beth Israel Medical Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

OsteoarthritisOsteonecrosis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBone DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Limitations and Caveats

This study was terminated early due to lagging follow up prior to the 15 year endpoint.

Results Point of Contact

Title
Director of Clinical Research
Organization
Stryker Orthopaedics®
ellen.axelson@stryker.com
201-831-5401

Study Officials

  • C. Lowry Barnes, MD

    Foundation for Musculoskeletal Research and Education

    STUDY CHAIR

  • Lawrence Morawa, MD

    Dearborn Orthopaedics

    PRINCIPAL INVESTIGATOR

  • Arthur Malkani, MD

    Jewish Physician Group

    PRINCIPAL INVESTIGATOR

  • Frank Kolisek, MD

    Orthopaedic Research Foundation, Inc.

    PRINCIPAL INVESTIGATOR

  • Steven Harwin, MD

    Beth Israel Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2009

First Posted

August 25, 2009

Study Start

June 1, 2001

Primary Completion

July 23, 2009

Last Updated

November 17, 2017

Results First Posted

February 15, 2013

Record last verified: 2013-04

Locations

US(5)