Total Knee Replacement With the ROCC Knee

• Sponsor: Bercovy, Michel, M.D. (Other)
• Overall Status: Completed
• CT.gov ID: NCT02127619
• Collaborator: (none)
• Enrollment: 500
• Location: 1
• Duration (Months): 157.9
• Patients Per Site Per Month: 3.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis; Rheumatoid Arthritis	Device: Total knee replacement with the ROCC® knee prosthesis	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 500 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Prospective Study of Total Knee Replacement With the ROCC Knee
• Study Start Date: Jan 1, 2001
• Actual Primary Completion Date: Jan 1, 2008
• Actual Study Completion Date: Mar 1, 2014

Outcome Measures

Primary Outcome Measures

1. locomotor function with the Knee society score [at a minimum of 5 years after surgery]

Secondary Outcome Measures

1. physical and sports activities with the UCLA activity score [at last follow-up examination, with minimum of 5 years after surgery]

2. clinical status with the Oxford Knee Score [before surgery]

3. clinical status with the Oxford knee score [at last follow-up examination, with minimum of 5 years after surgery]

4. WOMAC ARTHRITIS INDEX [before surgery]

5. WOMAC ARTHRITIS INDEX [at last follow-up examination, with minimum of 5 years after surgery]

Other Outcome Measures

1. patient satisfaction with the Forgotten Joint Score [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 [minimum 5 years after surgery]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 42 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinique Les Fontaines	Melun		France	77000

Sponsors and Collaborators

• Bercovy, Michel, M.D.

Investigators

• Principal Investigator: Michel Bercovy, md, Clinique Les Fontaines- 77000 - Melun- FRANCE

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr Bercovy, Orthopedic Surgeon, Bercovy, Michel, M.D.
• ClinicalTrials.gov Identifier: NCT02127619
• Other Study ID Numbers: 602-ROCC
• First Posted: May 1, 2014
• Last Update Posted: May 1, 2014
• Last Verified: Apr 1, 2014

• Keywords provided by Dr Bercovy, Orthopedic Surgeon, Bercovy, Michel, M.D.: knee prosthesis; total knee replacement; total knee arthroplasty; prospective study; Therapeutic level IV
• Additional relevant MeSH terms: Osteoarthritis

Study Results

No Results Posted as of May 1, 2014