OsteoarthritisNCT02127619
Total Knee Replacement With the ROCC Knee
A study testing Total knee replacement with the ROCC® knee prosthesis in people with Osteoarthritis and Rheumatoid Arthritis, run by Bercovy, Michel, M.D. at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 42 to 90 years
- Conditions the study is for
- Osteoarthritis, Rheumatoid Arthritis
- What is being tested?
- Total knee replacement with the ROCC® knee prosthesis
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2001to Mar 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 42 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all patients receiving a total knee
Who cannot join
- patients with severe psychiatric, neurologic, cardiologic or locomotor pathology occuring after the total knee replacement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Study of 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.
Read the 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.
- Conditions
- Osteoarthritis, Rheumatoid Arthritis
- Being tested
- Total knee replacement with the ROCC® knee prosthesis
- Keywords
- knee prosthesis, total knee replacement, total knee arthroplasty, prospective study, Therapeutic level IV
- Medical subject headings
- Osteoarthritis, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total knee replacement with the ROCC® knee prosthesisDevice
Also called Total knee arthroplasty, Total 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)
What is being measured
The primary outcome is the main question the study is designed to answer.
locomotor function with the Knee society score
Measured: at a minimum of 5 years after surgery
Secondary outcomes (5)
physical and sports activities with the UCLA activity score
Measured: at last follow-up examination, with minimum of 5 years after surgery
clinical status with the Oxford Knee Score
Measured: before surgery
clinical status with the Oxford knee score
Measured: at last follow-up examination, with minimum of 5 years after surgery
WOMAC ARTHRITIS INDEX
Measured: before surgery
WOMAC ARTHRITIS INDEX
Measured: at last follow-up examination, with minimum of 5 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2014 (estimated)
- Study startJan 2001
- Primary completionJan 2008
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bercovy, Michel, M.D.
- Responsible party
- Principal investigator, Dr Bercovy, Bercovy, Michel, M.D.
- Investigators
- Michel Bercovy, md, Principal investigator, Clinique Les Fontaines- 77000 - Melun- FRANCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02127619
- Sponsor's protocol ID
- 602-ROCC
- Status last verified
- Apr 2014
- First submitted
- 25 Apr 2014
- Last updated
- 1 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Total Knee Replacement With the ROCC Knee
- ClinicalTrials.gov ID
- NCT02127619
- Acronym / sponsor ID
- 602-ROCC
- Conditions
- Osteoarthritis, Rheumatoid Arthritis
- Keywords
- knee prosthesis, total knee replacement, total knee arthroplasty, prospective study, Therapeutic level IV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Bercovy, Michel, M.D.
- Study start
- Jan 2001
- Primary completion
- Jan 2008 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 1 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 42 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all patients receiving a total knee
Key exclusion criteria (1 listed)
- patients with severe psychiatric, neurologic, cardiologic or locomotor pathology occuring after the total knee replacement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total knee replacement with the ROCC® knee prosthesisAlso: Total knee arthroplasty, Total knee prosthesisreplacement of an osteoarthritic knee with a total knee prosthesis operation may be for a single knee ( unilateral) or both knees of a patient ( bilateral) | Device | – |
Primary outcome
locomotor function with the Knee society score
Time frame: at a minimum of 5 years after surgery
5 secondary outcomes
physical and sports activities with the UCLA activity score
Time frame: at last follow-up examination, with minimum of 5 years after surgery
clinical status with the Oxford Knee Score
Time frame: before surgery
clinical status with the Oxford knee score
Time frame: at last follow-up examination, with minimum of 5 years after surgery
WOMAC ARTHRITIS INDEX
Time frame: before surgery
WOMAC ARTHRITIS INDEX
Time frame: at last follow-up examination, with minimum of 5 years after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michel Bercovy, md principal investigator
Clinique Les Fontaines- 77000 - Melun- FRANCE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total knee replacement with the ROCC® knee prosthesis in people with Osteoarthritis and Rheumatoid Arthritis, run by Bercovy, Michel, M.D. at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
locomotor function with the Knee society score (time frame: at a minimum of 5 years after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2014.