OsteoarthritisGK10NCT02350049
Cementless Oxford Partial Knee Controlled Observational Study
An observational study of Osteoarthritis and Avascular Necrosis, run by Zimmer Biomet.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of the Cementless Oxford Partial Knee System. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Osteoarthritis, Avascular Necrosis
- How many people
- 391 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to Apr 2017
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 362 cases (121 investigational cases and 241 control cases) for primary efficacy and safety assessment (Primary Comparative Analysis Group); and exploratory assessment from one center in England. A total of approximately 1,000 investigational cases for "survivorship only" assessment from three centers.
Who may be able to join
- have primary diagnosis of osteoarthritis or avascular necrosis limited to the medial compartment of the knee
- signed informed consent for patients contributing to investigational or control if required
- Male or female over the age of 21 years at the time of surgery
- Undergone primary partial knee arthroplasty as unilateral arthroplasty or bilateral arthroplasty, simultaneously or otherwise
- Patients that are current residents of the United Kingdom
Who cannot join
- Evidence of infection, sepsis, and osteomyelitis at the time of surgery
- Use in the lateral compartment of the knee
- Rheumatoid arthritis or other forms of inflammatory joint disease
- Revision of a failed prosthesis, failed upper tibial osteotomy or post-traumatic arthritis after tibial plateau fracture
- Insufficiency of the collateral, anterior, or posterior cruciate ligaments which would preclude stability of the device
- Partial or full thickness cartilage disease or damage to central part of the lateral femoral condyle
Show all 18Show fewer
- Osteoporosis or insufficient bone stock
- Metabolic disorders which may impair bone formation
- Osteomalacia
- Distant foci of infection which may spread to the implant site
- Rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram
- Vascular insufficiency, muscular atrophy, neuromuscular disease
- Incomplete or deficient soft tissue surrounding the knee
- Charcot's disease
- A fixed varus deformity (not passively correctable) of greater than 15 degrees
- A flexion deformity greater than 15 degrees
- Refuse to sign informed consent if it is required
- Patients that are not current residents of the United Kingdom
About this study
Official title: Cementless Oxford Partial Knee Retrospective and Prospective Controlled Multi-center Observational Study
The purpose of this study is to evaluate the safety and effectiveness of the Cementless Oxford Partial Knee System.
Read the detailed description
The study is designed to document and compare the clinical and radiographic results of the Cementless Oxford Partial Knee System (investigational device) to those of the cemented Oxford Partial Knee System (control device).
- Conditions
- Osteoarthritis, Avascular Necrosis
- Medical subject headings
- Osteoarthritis, Osteonecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Investigational | Cementless Medial Partial Knee | |
| Control | Cemented Medial Partial Knee |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Endpoint- Safety & Efficacy (Radiographic Success, American Knee Society Score, Absence of Revision / Removal / Unanticipated Adverse Device Affects)
Radiographic Success, American Knee Society Score, Absence of Revision / Removal / Unanticipated Adverse Device Affects
Measured: 22+months
Secondary outcomes (4)
Survivorship (Cementless Only)
Minimum 1,000 cases to assess survivorship of cementless components
Measured: 22+ Months
American Knee Society Score
Assessment of Function and Range of Motion; retrospective study- data will be collected if available
Measured: 0-16 Week, 6 Month, 12 Month
Oxford Knee Score
Retrospective study; data will be collected if available.
Measured: 0-16 Weeks, 6 Months, 12 Months, 22+ Months
Adverse Events
Measured: Through 22+ Months Postop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2015 (estimated)
- Study startNov 2014
- Primary completionMar 2016
- Study completionApr 2017
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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 391 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Prof. David Murray, BA Hons, BChir, FRCS, MD, Principal investigator, Nuffield Orthopaedic CentreProf. Hemant Pandit, MBBS, MS, DNB, FRCS, DPhil, Study director, Nuffield Orthopaedic Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02350049
- Sponsor's protocol ID
- ORTHO.CR.GK10
- Acronym
- GK10
- Status last verified
- Dec 2017
- First submitted
- 15 Jul 2014
- Last updated
- 8 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: The primary analysis data is patient level data; collected in anticipation of potential PMA submission.
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cementless Oxford Partial Knee Retrospective and Prospective Controlled Multi-center Observational Study
- ClinicalTrials.gov ID
- NCT02350049
- Acronym / sponsor ID
- GK10 / ORTHO.CR.GK10
- Conditions
- Osteoarthritis, Avascular Necrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 391 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- Nov 2014 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 29 Jan 2015 (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 is to evaluate the safety and effectiveness of the Cementless Oxford Partial Knee System.
Detailed description
The study is designed to document and compare the clinical and radiographic results of the Cementless Oxford Partial Knee System (investigational device) to those of the cemented Oxford Partial Knee System (control device).
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational | – | –Cementless Medial Partial Knee |
| Control | – | –Cemented Medial Partial Knee |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 362 cases (121 investigational cases and 241 control cases) for primary efficacy and safety assessment (Primary Comparative Analysis Group); and exploratory assessment from one center in England. A total of approximately 1,000 investigational cases for "survivorship only" assessment from three centers.
Key inclusion criteria (5 listed)
- have primary diagnosis of osteoarthritis or avascular necrosis limited to the medial compartment of the knee
- signed informed consent for patients contributing to investigational or control if required
- Male or female over the age of 21 years at the time of surgery
- Undergone primary partial knee arthroplasty as unilateral arthroplasty or bilateral arthroplasty, simultaneously or otherwise
- Patients that are current residents of the United Kingdom
Key exclusion criteria (18 listed)
- Evidence of infection, sepsis, and osteomyelitis at the time of surgery
- Use in the lateral compartment of the knee
- Rheumatoid arthritis or other forms of inflammatory joint disease
- Revision of a failed prosthesis, failed upper tibial osteotomy or post-traumatic arthritis after tibial plateau fracture
- Insufficiency of the collateral, anterior, or posterior cruciate ligaments which would preclude stability of the device
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Composite Endpoint- Safety & Efficacy (Radiographic Success, American Knee Society Score, Absence of Revision / Removal / Unanticipated Adverse Device Affects)
Time frame: 22+months
Radiographic Success, American Knee Society Score, Absence of Revision / Removal / Unanticipated Adverse Device Affects
4 secondary outcomes
Survivorship (Cementless Only)
Time frame: 22+ Months
American Knee Society Score
Time frame: 0-16 Week, 6 Month, 12 Month
Oxford Knee Score
Time frame: 0-16 Weeks, 6 Months, 12 Months, 22+ Months
Adverse Events
Time frame: Through 22+ Months Postop
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 8 Dec 2017.
- Individual participant dataSharing planned: Undecided. The primary analysis data is patient level data; collected in anticipation of potential PMA submission.
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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.
Prof. David Murray, BA Hons, BChir, FRCS, MD principal investigator
Nuffield Orthopaedic Centre
Prof. Hemant Pandit, MBBS, MS, DNB, FRCS, DPhil study director
Nuffield Orthopaedic Centre
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis and Avascular Necrosis, run by Zimmer Biomet.
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 18 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 8 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Composite Endpoint- Safety & Efficacy (Radiographic Success, American Knee Society Score, Absence of Revision / Removal / Unanticipated Adverse Device Affects) (time frame: 22+months). 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 8 Dec 2017.