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Completed

NCT Number: NCT02127619

Total Knee Replacement With the ROCC Knee

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.

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Key information

Conditions

Osteoarthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Rheumatoid Arthritis Skin and Connective Tissue Diseases

Age range

42 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique Les Fontaines

Melun, 77000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Total knee replacement with the ROCC® knee prosthesis

Device

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)

Other names: Total knee arthroplasty, Total knee prosthesis

Primary outcomes

  1. locomotor function with the Knee society score

    Time frame: at a minimum of 5 years after surgery

Secondary outcomes

  1. physical and sports activities with the UCLA activity score

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

  2. clinical status with the Oxford Knee Score

    Time frame: before surgery

  3. clinical status with the Oxford knee score

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

  4. WOMAC ARTHRITIS INDEX

    Time frame: before surgery

  5. WOMAC ARTHRITIS INDEX

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

Other outcomes

  1. patient satisfaction with the Forgotten Joint Score

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

    this score asseses the perfection on patient's point of view for a total knee replacement

  2. positioning and quality of the fixation of a total knee replacement

    Time frame: minimum 5 years after surgery

Sponsors and collaborators

Lead sponsor

Bercovy, Michel, M.D.

Indiv

Registry information

Official study title

Prospective Study of Total Knee Replacement With the ROCC Knee

Important dates

Study start
2001
Primary completion
2008
Study completion
2014
First posted
May 1, 2014
Registry last updated
May 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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