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Total Knee Replacement With the ROCC Knee

Prospective Study of Total Knee Replacement With the ROCC Knee

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02127619
Enrollment
500
Registered
2014-05-01
Start date
2001-01-31
Completion date
2014-03-31
Last updated
2014-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Rheumatoid Arthritis

Keywords

knee prosthesis, total knee replacement, total knee arthroplasty, prospective study, Therapeutic level IV

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.

Detailed description

Clinical and radiographic results , complications, early post-operative and late functional outcome and survivorship were studied in a continuous prospective series of 500 patients ( 602 knees) managed using the ROCC knee ( BIOMET INC - Warsaw- IND, USA). A minimum follow-up of 5 years was required.

Interventions

DEVICETotal knee replacement with the ROCC® knee prosthesis

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)

Sponsors

Bercovy, Michel, M.D.
Lead SponsorINDIV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
42 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* all patients receiving a total knee

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
locomotor function with the Knee society scoreat a minimum of 5 years after surgery

Secondary

MeasureTime frame
physical and sports activities with the UCLA activity scoreat last follow-up examination, with minimum of 5 years after surgery
clinical status with the Oxford Knee Scorebefore surgery
clinical status with the Oxford knee scoreat last follow-up examination, with minimum of 5 years after surgery
WOMAC ARTHRITIS INDEXbefore surgery

Other

MeasureTime frameDescription
patient satisfaction with the Forgotten Joint Scoreat last follow-up examination, with minimum of 5 years after surgerythis score asseses the perfection on patient's point of view for a total knee replacement
positioning and quality of the fixation of a total knee replacementminimum 5 years after surgery

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026