OsteoarthritisNCT01763684
Oxford Signature vs. Conventional Global Study
A study testing Signature Custom Guides and Conventional Instrumentation in people with Osteoarthritis and Osteoarthritis, Knee, run by Zimmer Biomet at 7 sites in United States.
Trial summary
This study will compare alignment criteria in the Oxford Partial Knee using conventional instrumentation and Signature Custom Guides in order to determine if the use of the Signature Custom Guides results in a higher percentage of knees achieving optimal alignment. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Osteoarthritis, Osteoarthritis, Knee, Osteonecrosis
- What is being tested?
- Signature Custom Guides and Conventional Instrumentation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 266 participants
- Where
- 7 sitesUnited States
- Study dates
- Sep 2012to Aug 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Intended for use in individuals with osteoarthritis or Avascular necrosis limited to the medial compartment of the knee that is also lacking patellofemoral or lateral compartment disease.
- Use of cementless femoral fixation is permitted outside of the United States if it complies with all local, state, and/or national and international regulations. The same technique must be used consistently throughout the course of the study with all cases
- Patients 21 and over
Who cannot join
- Use of Cementless Fixation in the United States
- Infection, sepsis or osteomyelitis
- Use in lateral compartment of the knee
- Rheumatoid arthritis or other forms of inflammatory joint disease
- Revision of 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.
Show all 20Show fewer
- Disease or damage to the lateral compartment of the knee
- Uncooperative patient or patient with neurologic disorders who is incapable of following directions
- Osteoporosis in the United States / Insufficient bone stock outside the United States
- Metabolic disorders which may impair bone formation
- Osteomalacia
- Distant foci of infections which may spread to 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.
- Non-staged Bilateral patients
- Patients who refuse, cannot, or should not receive a CT or MRI. Since patients are randomized into treatment groups, all patients must be able to receive an MRI (should follow local MRI screening protocol). This excludes patients who have metal artifacts in the knee, patients who are too large to fit into the knee coil, patients with pacemakers, patients unable to lie still for the duration of the MRI, and patients who are claustrophobic.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Texas Institute for Hip & Knee Surgery
Austin, Texas, 78751
University of Missouri-Columbia Hospital and Clinics
Columbia, Missouri, 65212
Joint Implant Surgeons
Columbus, Ohio, 43054
Duke University Medical Center
Durham, North Carolina, 27703
Orthopedic and Sports Medicine Center
Elkhart, Indiana, 46514
Advanced Orthopedics
Richmond, Virginia, 23294
The Orthopaedic Center
Rockville, Maryland, 20850
About this study
Official title: A Global Comparison of Signature Guides and Conventional Instrumentation in the Oxford Partial Knee
This study will compare alignment criteria in the Oxford Partial Knee using conventional instrumentation and Signature Custom Guides in order to determine if the use of the Signature Custom Guides results in a higher percentage of knees achieving optimal alignment. The study will also examine outcomes with high volume surgeons (>30 cases/year) and low volume surgeons (<10 cases/year).
Read the detailed description
The primary objectives of this global clinical study are to collect data to assess the following clinical evidence parameters that were gathered from Biomet team members and KOL globally for this product:
- Evaluate the performance \& accuracy of the Oxford Partial Knee System with Signature Knee Guide in comparison to conventional instrumentation.
- Compare the accuracy of Signature Guides between two user profiles: high volume surgeons \& low volume surgeons in a global mix.
- Assess potential economic \& efficiency advantages in the short term and long-term: OR efficiency, patient quality of life and activity, clinical outcomes.
- Conditions
- Osteoarthritis, Osteoarthritis, Knee, Osteonecrosis
- Being tested
- Signature Custom Guides, Conventional Instrumentation
- Keywords
- Osteoarthritis, Osteoarthritis, Knee, Osteonecrosis, Arthritis, Knee Arthritis, Knee Replacement
- Medical subject headings
- Osteoarthritis, Osteoarthritis, Knee, Osteonecrosis, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Signature Custom GuidesDevice
Signature Custom Guides: Signature Custom Guides are intended to be used as a surgical instrument to assist in the positioning of knee replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans (preoperative MRI).
Conventional InstrumentationProcedure or surgery
Traditional partial knee arthroplasty without the use of Signature technology.
| Study group | Role | What they receive |
|---|---|---|
| Signature Custom Guides | Active comparator | Oxford Partial Knee implanted using Signature Custom Guides Receives: Device: Signature Custom Guides |
| Conventional Instrumentation | Active comparator | Oxford Partial Knee implanted using Conventional Instrumentation Receives: Procedure: Conventional Instrumentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Knees Achieving Optimal Alignment
Percentage of Knees Achieving Optimal Alignment defined as a difference of 5 or less between all target and observed angles.
Measured: 12 weeks
Secondary outcomes (10)
Instruments Used During Surgery
Number of Instrument cases used to complete index surgery.
Measured: Operative
Knee Society Functional Score
Functional Score from Knee Society Score. These are 3 of the 10 items. Scored from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions
Measured: 1 Year
Leg Alignment Femoral Varus/Valgus
Mechanical Leg Alignment of Components (degrees): Difference of Femoral Varus/Valgus angle as measured via CT-scan directly post-operative, vs target angle
Measured: Directly Postoperative
Blood Loss
Blood Loss during surgery
Measured: Right after surgery (up to 2 hours after surgery)
Knee Society Objective Score
Objective score from Knee Society Score. These are 7 of the 10 items. Scored from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions
Measured: 1 Year
Oxford Knee Score
Oxford Knee Score (OKS). Scored from 0 to 48 with 0 being the worst possible outcome and 48 being the best outcome
Measured: 1 Year
EQ5D Score
EuroQol 5D Quality of Life score. Range from 0 to 1 with 1 being the best outcome.
Measured: 1 Year
Leg Alignment Femoral Flexion/Extension
Mechanical Leg Alignment of Components (degrees): Difference of Femoral Flexion/Extension angle as measured via CT-scan directly post-operative, vs target angle
Measured: Directly Postoperative
Leg Alignment Tibial Varus/Valgus
Mechanical Leg Alignment of Components (degrees): Difference of Tibial Varus/Valgus angle as measured via CT-scan directly post-operative, vs target angle
Measured: Directly Postoperative
Leg Alignment Tibial Flexion/Extension
Mechanical Leg Alignment of Components (degrees): Difference of Tibial Flexion/Extension angle as measured via CT-scan directly post-operative, vs target angle
Measured: Directly Postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2013 (estimated)
- Study startSep 2012
- Primary completionAug 2016
- Study completionAug 2016
Why it stopped: Due to slow enrollment and not being able to reach the primary endpoint
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 266 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Russell Schenck, Ph.D., Study director, Zimmer Biomet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01763684
- Sponsor's protocol ID
- ORTHO.CR.GK7
- Status last verified
- Mar 2021
- First submitted
- 6 Nov 2012
- Last updated
- 23 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Global Comparison of Signature Guides and Conventional Instrumentation in the Oxford Partial Knee
- ClinicalTrials.gov ID
- NCT01763684
- Acronym / sponsor ID
- ORTHO.CR.GK7
- Conditions
- Osteoarthritis, Osteoarthritis, Knee, Osteonecrosis
- Keywords
- Osteoarthritis, Osteoarthritis, Knee, Osteonecrosis, Arthritis, Knee Arthritis, Knee Replacement
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to slow enrollment and not being able to reach the primary endpoint
- Enrolment
- 266 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- Sep 2012 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 9 Jan 2013 (estimated)
- Results
- Posted 23 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare alignment criteria in the Oxford Partial Knee using conventional instrumentation and Signature Custom Guides in order to determine if the use of the Signature Custom Guides results in a higher percentage of knees achieving optimal alignment. The study will also examine outcomes with high volume surgeons (>30 cases/year) and low volume surgeons (<10 cases/year).
Detailed description
The primary objectives of this global clinical study are to collect data to assess the following clinical evidence parameters that were gathered from Biomet team members and KOL globally for this product:
- Evaluate the performance \& accuracy of the Oxford Partial Knee System with Signature Knee Guide in comparison to conventional instrumentation.
- Compare the accuracy of Signature Guides between two user profiles: high volume surgeons \& low volume surgeons in a global mix.
- Assess potential economic \& efficiency advantages in the short term and long-term: OR efficiency, patient quality of life and activity, clinical outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Signature Custom Guides | Active comparator | Device: Signature Custom GuidesOxford Partial Knee implanted using Signature Custom Guides |
| Conventional Instrumentation | Active comparator | Procedure: Conventional InstrumentationOxford Partial Knee implanted using Conventional Instrumentation |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Intended for use in individuals with osteoarthritis or Avascular necrosis limited to the medial compartment of the knee that is also lacking patellofemoral or lateral compartment disease.
- Use of cementless femoral fixation is permitted outside of the United States if it complies with all local, state, and/or national and international regulations. The same technique must be used consistently throughout the course of the study with all cases
- Patients 21 and over
Key exclusion criteria (20 listed)
- Use of Cementless Fixation in the United States
- Infection, sepsis or osteomyelitis
- Use in lateral compartment of the knee
- Rheumatoid arthritis or other forms of inflammatory joint disease
- Revision of failed prosthesis, failed upper tibial osteotomy, or post traumatic arthritis after tibial plateau fracture
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 |
|---|---|---|
| Signature Custom GuidesSignature Custom Guides: Signature Custom Guides are intended to be used as a surgical instrument to assist in the positioning of knee replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans (preoperative MRI). | Device | Signature Custom Guides |
| Conventional InstrumentationTraditional partial knee arthroplasty without the use of Signature technology. | Procedure or surgery | Conventional Instrumentation |
Primary outcome
Percentage of Knees Achieving Optimal Alignment
Time frame: 12 weeks
Percentage of Knees Achieving Optimal Alignment defined as a difference of 5 or less between all target and observed angles.
10 secondary outcomes
Instruments Used During Surgery
Time frame: Operative
Knee Society Functional Score
Time frame: 1 Year
Leg Alignment Femoral Varus/Valgus
Time frame: Directly Postoperative
Blood Loss
Time frame: Right after surgery (up to 2 hours after surgery)
Knee Society Objective Score
Time frame: 1 Year
Oxford Knee Score
Time frame: 1 Year
EQ5D Score
Time frame: 1 Year
Leg Alignment Femoral Flexion/Extension
Time frame: Directly Postoperative
Leg Alignment Tibial Varus/Valgus
Time frame: Directly Postoperative
Leg Alignment Tibial Flexion/Extension
Time frame: Directly Postoperative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Russell Schenck, Ph.D. study director
Zimmer Biomet
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Signature Custom Guides and Conventional Instrumentation in people with Osteoarthritis and Osteoarthritis, Knee, run by Zimmer Biomet at 7 sites in United States.
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 3 inclusion and 20 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: stopped early, as of the sponsor's last update on 23 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. 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?
Yes. Results are posted in the registry (first posted 23 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Knees Achieving Optimal Alignment (time frame: 12 weeks). 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 23 Apr 2021.