OsteoarthritisNCT00755144
A Randomized Control Trial to Assess Early Clinical and Functional Outcome of the ROCC and LCS Total Knee Implant Designs
A study testing LCS Knee and ROCC Knee in people with Osteoarthritis, run by Zimmer Biomet at 1 site in United Kingdom.
Trial summary
This is a prospective Randomised Control Trial to compare the Early Clinical and Functional Outcome of the ROCC and LCS total knee arthroplasty implant designs. Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- LCS Knee and ROCC Knee
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2007to Jan 2011
- 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 Up to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients suitable for cementless knee replacement
- Patients skeletally mature and under 80 years of age at pre-operative clinic
- Patients presenting with osteoarthritis of the knee
- Patients must be ambulatory at time of pre-operative clinic
- Patients must be able to understand instructions and be will to return for follow-up
Who cannot join
- Previous knee surgery (except arthroscopic/open menisectomy)
- Patients with inflammatory arthritis
- Patients with significant medical co-morbidity - ASA IV
- Disorders causing abnormal gait or significant pain
- Patients unable to consent
- Severe visual impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomized Study on Early Clinical and Functional Outcome of the ROCC and LCS Total Knee Arthroplasty Implant Designs
This is a prospective Randomised Control Trial to compare the Early Clinical and Functional Outcome of the ROCC and LCS total knee arthroplasty implant designs.
Read the detailed description
This study compares two similar designs of cementless rotating bearing total condylar knee replacements. The study will be conducted at a single clinical unit with a senior orthopaedic surgeon implanting all devices.Their performances will be assessed by clinical scores and comprehensive function outcome documentation undertaken by qualified physiotherapists. The persons undertaking the assessments will be blinded to which implants the patients have.
- Conditions
- Osteoarthritis
- Being tested
- LCS Knee, ROCC Knee
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LCS KneeDevice
Cementless total knee arthroplasty with LCS Knee
ROCC KneeDevice
Cementless total knee arthroplasty with ROCC Knee
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | ROCC Receives: Device: ROCC Knee |
| 2 | Active comparator | LCS Receives: Device: LCS Knee |
What is being measured
The primary outcome is the main question the study is designed to answer.
American Knee Society Score
Measured: Preoperative, 8weeks, 1 year
Secondary outcomes (2)
WOMAC
Measured: preoperative, 8 weeks, 1 year
VAS Pain
Measured: Preoperative, 4weeks, 8weeks, 3months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2008 (estimated)
- Study startApr 2007
- Primary completionJan 2011
- Study completionJan 2011
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biomet U.K. Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00755144
- Sponsor's protocol ID
- BMET UK 05
- Status last verified
- Jun 2017
- First submitted
- 17 Sep 2008
- Last updated
- 20 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Study on Early Clinical and Functional Outcome of the ROCC and LCS Total Knee Arthroplasty Implant Designs
- ClinicalTrials.gov ID
- NCT00755144
- Acronym / sponsor ID
- BMET UK 05
- Conditions
- Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Collaborators
- Biomet U.K. Ltd.
- Study start
- Apr 2007
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 18 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 is a prospective Randomised Control Trial to compare the Early Clinical and Functional Outcome of the ROCC and LCS total knee arthroplasty implant designs.
Detailed description
This study compares two similar designs of cementless rotating bearing total condylar knee replacements. The study will be conducted at a single clinical unit with a senior orthopaedic surgeon implanting all devices.Their performances will be assessed by clinical scores and comprehensive function outcome documentation undertaken by qualified physiotherapists. The persons undertaking the assessments will be blinded to which implants the patients have.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: ROCC KneeROCC |
| 2 | Active comparator | Device: LCS KneeLCS |
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients suitable for cementless knee replacement
- Patients skeletally mature and under 80 years of age at pre-operative clinic
- Patients presenting with osteoarthritis of the knee
- Patients must be ambulatory at time of pre-operative clinic
- Patients must be able to understand instructions and be will to return for follow-up
Key exclusion criteria (6 listed)
- Previous knee surgery (except arthroscopic/open menisectomy)
- Patients with inflammatory arthritis
- Patients with significant medical co-morbidity - ASA IV
- Disorders causing abnormal gait or significant pain
- Patients unable to consent
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 |
|---|---|---|
| LCS KneeCementless total knee arthroplasty with LCS Knee | Device | 2 |
| ROCC KneeCementless total knee arthroplasty with ROCC Knee | Device | 1 |
Primary outcome
American Knee Society Score
Time frame: Preoperative, 8weeks, 1 year
2 secondary outcomes
WOMAC
Time frame: preoperative, 8 weeks, 1 year
VAS Pain
Time frame: Preoperative, 4weeks, 8weeks, 3months, 1 year
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 20 Jun 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LCS Knee and ROCC Knee in people with Osteoarthritis, run by Zimmer Biomet at 1 site in United Kingdom.
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 5 inclusion and 6 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 20 Jun 2017. 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 United Kingdom. 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?
American Knee Society Score (time frame: Preoperative, 8weeks, 1 year). 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 20 Jun 2017.