NCT02127619

Brief Summary

The purpose of this study was to assess the results of a Total Knee prosthesis specifically intended to enhance functional performance , especially in terms of physical and sports activity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2001

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2001

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
6.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 1, 2014

Completed
Last Updated

May 1, 2014

Status Verified

April 1, 2014

Enrollment Period

7 years

First QC Date

April 25, 2014

Last Update Submit

April 28, 2014

Conditions

OsteoarthritisRheumatoid Arthritis

Keywords

knee prosthesistotal knee replacementtotal knee arthroplastyprospective studyTherapeutic level IV

Outcome Measures

Primary Outcomes (1)

  • locomotor function with the Knee society score

    at a minimum of 5 years after surgery

Secondary Outcomes (5)

  • physical and sports activities with the UCLA activity score

    at last follow-up examination, with minimum of 5 years after surgery

  • clinical status with the Oxford Knee Score

    before surgery

  • clinical status with the Oxford knee score

    at last follow-up examination, with minimum of 5 years after surgery

  • WOMAC ARTHRITIS INDEX

    before surgery

  • WOMAC ARTHRITIS INDEX

    at last follow-up examination, with minimum of 5 years after surgery

Other Outcomes (2)

  • patient satisfaction with the Forgotten Joint Score

    at last follow-up examination, with minimum of 5 years after surgery

  • positioning and quality of the fixation of a total knee replacement

    minimum 5 years after surgery

Interventions

Total knee replacement with the ROCC® knee prosthesisDEVICE

replacement of an osteoarthritic knee with a total knee prosthesis operation may be for a single knee ( unilateral) or both knees of a patient ( bilateral)

Also known as: Total knee arthroplasty, Total knee prosthesis

Eligibility Criteria

Age42 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • all patients receiving a total knee

You may not qualify if:

  • patients with severe psychiatric, neurologic, cardiologic or locomotor pathology occuring after the total knee replacement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique Les Fontaines

Melun, 77000, France

Location

MeSH Terms

Conditions

OsteoarthritisArthritis, Rheumatoid

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Michel Bercovy, md

    Clinique Les Fontaines- 77000 - Melun- FRANCE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDIV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Orthopedic Surgeon

Study Record Dates

First Submitted

April 25, 2014

First Posted

May 1, 2014

Study Start

January 1, 2001

Primary Completion

January 1, 2008

Study Completion

March 1, 2014

Last Updated

May 1, 2014

Record last verified: 2014-04

Locations

FR(1)