Arthritis of KneeNCT00758901
ROCC Knee Data Collection
An observational study of Arthritis of Knee, run by Zimmer Biomet at 3 sites in 3 countries.
Trial summary
This observational study intends to collect efficacy and safety data on ROCC Knee system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis of Knee
- What is being tested?
- Knee Replacement (with ROCC Knee prosthesis)
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Nov 2003to Dec 2010
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive series of patients received ROCC Knee prostheses for osteoarthritis, rheumatoid arthritis and bone necrosis affecting two knee compartments, correction of genu varus, genu valgus or post-traumatic deformities, sequelae of prior procedures
Patients suitable for Knee Replacement for:
- osteoarthritis,
- rheumatoid arthritis
- bone necrosis affecting two knee compartments,
- correction of genu varus, genu valgus or post-traumatic deformities,
- sequelae of prior procedures.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: A Prospective, Multicentre Study Evaluating the Clinical Performance of the ROCC Knee Prosthesis
This observational study intends to collect efficacy and safety data on ROCC Knee system.
Read the detailed description
The ROCC® prosthesis is a rotating platform with:
- Highly congruent surface contact,
- NON CONSTRAINED kinematics allowing posterior roll back until 110° then anterior in hyperflexion like a normal knee
- Allowing asymmetric movement
- Conditions
- Arthritis of Knee
- Being tested
- Knee Replacement (with ROCC Knee prosthesis)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Knee Replacement (with ROCC Knee prosthesis)Device
Also called ROCC Knee prosthesis
Knee Replacement (with ROCC Knee prosthesis)
| Study group | Role | What they receive |
|---|---|---|
| 1 ROCC Knee prosthesis | Consecutive series of patients with ROCC Knee prosthesis. Receives: Device: Knee Replacement (with ROCC Knee prosthesis) |
What is being measured
The primary outcome is the main question the study is designed to answer.
American Knee Score
Measured: 3 months, 1yr, 2yr, 3yr, 4yr and 5 yr
Secondary outcomes (2)
Complication
Measured: Any time
Patient Satisfaction
Measured: 3 months, 1yr, 2yr, 3yr, 4yr and 5 yr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2008 (estimated)
- Study startNov 2003
- Primary completionDec 2010
- Study completionDec 2010
Why it stopped: Site Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis of KneeStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biomet France SARL
- Responsible party
- Sponsor
- Investigators
- Michel BERCOVY, MD, Principal investigator, Clinique des Fontaines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00758901
- Sponsor's protocol ID
- BMET FR 03
- Status last verified
- Mar 2017
- First submitted
- 23 Sep 2008
- Last updated
- 10 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicentre Study Evaluating the Clinical Performance of the ROCC Knee Prosthesis
- ClinicalTrials.gov ID
- NCT00758901
- Acronym / sponsor ID
- BMET FR 03
- Conditions
- Arthritis of Knee
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Site Decision
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Collaborators
- Biomet France SARL
- Study start
- Nov 2003
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 25 Sep 2008 (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.
This observational study intends to collect efficacy and safety data on ROCC Knee system.
Detailed description
The ROCC® prosthesis is a rotating platform with:
- Highly congruent surface contact,
- NON CONSTRAINED kinematics allowing posterior roll back until 110° then anterior in hyperflexion like a normal knee
- Allowing asymmetric movement
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 ROCC Knee prosthesis | – | Device: Knee Replacement (with ROCC Knee prosthesis)Consecutive series of patients with ROCC Knee prosthesis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive series of patients received ROCC Knee prostheses for osteoarthritis, rheumatoid arthritis and bone necrosis affecting two knee compartments, correction of genu varus, genu valgus or post-traumatic deformities, sequelae of prior procedures
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 |
|---|---|---|
| Knee Replacement (with ROCC Knee prosthesis)Also: ROCC Knee prosthesisKnee Replacement (with ROCC Knee prosthesis) | Device | 1 ROCC Knee prosthesis |
Primary outcome
American Knee Score
Time frame: 3 months, 1yr, 2yr, 3yr, 4yr and 5 yr
2 secondary outcomes
Complication
Time frame: Any time
Patient Satisfaction
Time frame: 3 months, 1yr, 2yr, 3yr, 4yr and 5 yr
Results and safety
The study was stopped early (reason given: Site Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2017.
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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 des Fontaines
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis of Knee, run by Zimmer Biomet at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: stopped early, as of the sponsor's last update on 10 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Austria, France, Spain. 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 was stopped early (reason given: Site Decision). Results are not available in the source record.
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?
American Knee Score (time frame: 3 months, 1yr, 2yr, 3yr, 4yr and 5 yr). 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 10 Mar 2017.