NCT00758901

Brief Summary

This observational study intends to collect efficacy and safety data on ROCC Knee system.

Trial Health

60
Monitor

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2003

Longer than P75 for all trials

Geographic Reach
3 countries

3 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

November 1, 2003

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

September 23, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 25, 2008

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

March 10, 2017

Status Verified

March 1, 2017

Enrollment Period

7.1 years

First QC Date

September 23, 2008

Last Update Submit

March 9, 2017

Conditions

Arthritis of Knee

Outcome Measures

Primary Outcomes (1)

  • American Knee Score

    3 months, 1yr, 2yr, 3yr, 4yr and 5 yr

Secondary Outcomes (2)

  • Complication

    Any time

  • Patient Satisfaction

    3 months, 1yr, 2yr, 3yr, 4yr and 5 yr

Study Arms (1)

1 ROCC Knee prosthesis

Consecutive series of patients with ROCC Knee prosthesis.

Device: Knee Replacement (with ROCC Knee prosthesis)

Interventions

Knee Replacement (with ROCC Knee prosthesis)DEVICE

Knee Replacement (with ROCC Knee prosthesis)

Also known as: ROCC Knee prosthesis
1 ROCC Knee prosthesis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive series of patients received ROCC Knee prostheses for osteoarthritis, rheumatoid arthritis and bone necrosis affecting two knee compartments, correction of genu varus, genu valgus or post-traumatic deformities, sequelae of prior procedures

Patients suitable for Knee Replacement for: * osteoarthritis, * rheumatoid arthritis * bone necrosis affecting two knee compartments, * correction of genu varus, genu valgus or post-traumatic deformities, * sequelae of prior procedures.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (3)

A. ö Landeskrankenhaus Gmunden

Gmunden, Austria

Location

Clinique des Fontaines

Meulin, France

Location

Hospital Torrecardenas

Almería, Spain

Location

MeSH Terms

Interventions

Arthroplasty, Replacement, Knee

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Michel BERCOVY, MD

    Clinique des Fontaines

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2008

First Posted

September 25, 2008

Study Start

November 1, 2003

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

March 10, 2017

Record last verified: 2017-03

Locations

ES(1)FR(1)AU(1)