ROCC Knee Data Collection | NCT00758901

Studies
ROCC Knee Data Collection

NCT00758901

Sponsor

Zimmer Biomet

Status

Terminated

Last Update Posted

Mar 10, 2017Actual

Enrollment

200Actual

Phase

Not provided

Conditions

Arthritis of Knee

Interventions

Knee Replacement (with ROCC Knee prosthesis)

Countries

Austria
France
Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Site Decision

Expanded Access Info

Start Date

Nov 2003

Primary Completion Date

Dec 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Sep 23, 2008

First Submission Date that Met QC Criteria

Sep 23, 2008

First Posted Date

Sep 25, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 9, 2017

Last Update Posted Date

Mar 10, 2017Actual

Name	Class
Biomet France SARL	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

The ROCC® prosthesis is a rotating platform with:

Highly congruent surface contact,
NON CONSTRAINED kinematics allowing posterior roll back until 110° then anterior in hyperflexion like a normal knee
Allowing asymmetric movement

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1 ROCC Knee prosthesis		Consecutive series of patients with ROCC Knee prosthesis.	Device: Knee Replacement (with ROCC Knee prosthesis)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Knee Replacement (with ROCC Knee prosthesis)	Device	Knee Replacement (with ROCC Knee prosthesis)	1 ROCC Knee prosthesis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
American Knee Score		3 months, 1yr, 2yr, 3yr, 4yr and 5 yr

Secondary Outcomes

Measure	Description	Time Frame
Complication		Any time
Patient Satisfaction		3 months, 1yr, 2yr, 3yr, 4yr and 5 yr

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michel BERCOVY, MD	Clinique des Fontaines	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
A. ö Landeskrankenhaus Gmunden		Gmunden			Austria
Clinique des Fontaines

Intervention Browse Module

MeSH Terms

ID	Term
D019645	Arthroplasty, Replacement, Knee

Ancestor Terms

ID	Term
D019643	Arthroplasty, Replacement
D001178	Arthroplasty
D019637	Orthopedic Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided