Osteoarthritis, KneeNCT01473134
Safety and Efficacy of the Oxford Cementless Partial Knee System
A study testing Oxford Cementless Partial Knee and Oxford Cemented Partial Knee in people with Osteoarthritis, Knee and Avascular Necrosis of the Medial Femoral Condyle, run by Zimmer Biomet at 8 sites in United States.
Trial summary
The objective of this clinical investigation is to evaluate the safety and effectiveness of the Oxford® Cementless Partial Knee System. The Oxford® Cementless Partial Knee System is intended to help the patients diagnosed with osteoarthritis or avascular necrosis gain mobility and decrease pain. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Osteoarthritis, Knee, Avascular Necrosis of the Medial Femoral Condyle
- What is being tested?
- Oxford Cementless Partial Knee and Oxford Cemented Partial Knee
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 8 sitesUnited States
- Study dates
- Dec 2011to 30 Nov 2021
- Phase
- Interventional
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
- Patients with a preoperative Knee Society Assessment Score of <70
- Patients undergoing primary partial knee arthroplasty as unilateral arthroplasty or bilateral arthroplasty, simultaneously or otherwise
- Patients diagnosed with osteoarthritis or avascular necrosis limited to the medial compartment of the operative knee joint
- Male or female patients who are at least 21 years of age at the time of surgery
- Patients with full thickness cartilage loss, with or without bone loss in the medial compartment
- Patients with functionally intact Anterior Cruciate Ligament (ACL) and Posterior Cruciate Ligament (PCL)
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- Patients who needs to obtain relief of pain and/or improved function in their knee
- Patients with fixed flexion deformity <15 degrees
- Patients who are able to follow postoperative care instructions
- Patients who are willing and able to return for scheduled follow-up evaluations
- Patients in which natural alignment can be restored
- Patients who have completed a valid, Institutional Review Board (IRB) approved Informed Consent Form
- Patients with child-bearing potential who voluntarily agree to prevent pregnancy for 2 years following device implantation
Who cannot join
- Patients with a preoperative Knee Society Assessment Score of greater than or equal to 70
- Patients in which the device would be used to revise a failed prosthesis
- Patients who are less than 21 years of age, at the time of surgery
- Disease or damage to the lateral part of the knee that in the investigator's opinion contraindicates a partial knee replacement
- Patients diagnosed with rheumatoid arthritis or other forms of inflammatory joint disease
- Patients diagnosed with a failed upper tibial osteotomy in the operative knee
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- Patients diagnosed with post-traumatic arthritis after tibial plateau fracture
- Patients who have had a patellectomy
- Patients with a flexion deformity > 15 degrees
- Patients with a fixed varus deformity > 15 degrees
- Patients who have rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
- Patients with a fused knee on operative side(s)
- Patients who have active or suspected infection, local or systemic that, in the opinion of the investigator, may put patients at undue risk
- Patients with pre-existing condition(s) that may interfere with the survival of the implants or their outcomes, including:
- Sickle Cell Anemia
- Lower extremity muscular atrophy
- Neuromuscular disease
- Vascular insufficiency
- Metabolic Disorders which impair bone formation
- Paget's Disease
- Charcot's Disease
- Osteomalacia
- Severe Osteoporosis
- Patients with clinical conditions that may limit follow-up (in the opinion of the investigator) including:
- Immunocompromised conditions (i.e. HIV)
- Hepatitis
- Tuberculosis
- Neoplastic disease such as cancer of the prostate, lung, stomach, cervix, etc.
- Chronic renal failure
- Organ transplant (i.e. heart, liver, lung, etc.) recipients
- Known disease process that in the opinion of the investigator may limit long term (4 year) follow-up (i.e. multiple sclerosis, leukemia, lymphoma, etc.)
- Patients diagnosed with Parkinson's or Alzheimer's Disease
- Patients who have had an above-knee amputation in the contralateral leg
- Instability or deformity of the ligaments and/or surrounding soft tissue, which would preclude stability of the prostheses
- Patients with a known metal allergy
- Prisoners or, individuals who are known to be abusing drugs or alcohol or are mentally incompetent
- Patients who have received systemic steroids within the past 6 months or steroid injections into the affected knee within the previous 6 weeks prior to enrollment
- Patients who are pregnant
- Patients with severe valgus or varus knees (valgus or varus angulation of more than 20 degrees) where collateral ligament, iliotibial band, or popliteal release is required
- Patients who refuse to sign the IRB approved Informed Consent Form
- Participation in an interventional clinical research study procedure, other than a bilateral knee arthroplasty in this study, within the past 12 months
- Patients with a history of osteomyelitis or sepsis of the index knee
- Patients who require patellar resurfacing
- Patients who are not skeletally mature
- Patients who have had a total hip replacement procedure < 18 months prior to entering the study
- Patients who have had a contralateral non-study knee replacement procedure < 18 months prior to entering the study
- Patients who are found intraoperatively to have inadequate bone stock or other conditions that contraindicate a partial knee replacement
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Anderson Orthopedic Clinic
Alexandria, Virginia, 22306
Miller Orthopaedic Affiliates
Council Bluffs, Iowa, 51503
Twin City Orthopedics
Edina, Minnesota, 55435
Orthopedic & Sports Medicine Center of Northern Indiana, Inc.
Elkhart, Indiana, 46514
OrthoCarolina
Huntersville, North Carolina, 28078
Midwest Center for Hip and Knee Surgery
Indianapolis, Indiana, 46241
Joint Implant Surgeons, Inc
New Albany, Ohio, 43054
Texas Center for Joint Replacements
Plano, Texas, 75093
About this study
Official title: A Randomized Clinical Study to Compare the Safety and Efficacy of the Oxford Cementless Partial Knee System
The objective of this clinical investigation is to evaluate the safety and effectiveness of the Oxford® Cementless Partial Knee System. The Oxford® Cementless Partial Knee System is intended to help the patients diagnosed with osteoarthritis or avascular necrosis gain mobility and decrease pain. All of the risks common to a conventional joint replacement are possible with this device as certain risks are associated with any invasive procedures. The study is designed to document and compare the clinical and radiographic results of the Oxford® Cementless Partial Knee System to those of the cemented Oxford® Partial Knee System (control treatment).
Read the detailed description
Prospectively controlled, randomized Investigational study. Patients are asked to come in pre-operatively, surgery, 6 weeks, 6 months, 1 year, 2 years and annually until the last patient reaches their 2 year visit. Product has not been cleared for use.
- Being tested
- Oxford Cementless Partial Knee, Oxford Cemented Partial Knee
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxford Cementless Partial KneeDevice
Oxford Partial Knee applied without bone cement.
Oxford Cemented Partial KneeDevice
Oxford Partial Knee applied with bone cement.
| Study group | Role | What they receive |
|---|---|---|
| Oxford Cementless Partial Knee | Experimental | Oxford Partial Knee implanted without bone cement. Receives: Device: Oxford Cementless Partial Knee |
| Oxford Cemented Partial Knee | Active comparator | Oxford Partial Knee applied with bone cement. Receives: Device: Oxford Cemented Partial Knee |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic Success
This is a binary endpoint in which a knee is either a "success" or "failure".
To obtain a successful radiographic endpoint, a knee must meet the following criteria at the 22+ month interval.
- Absence of osteolysis
- No migration/subsidence of any femoral or tibial component
- Absence of fractured component
Conversely, a radiographic failure is defined as follows:
- Presence of osteolysis defined as a radiolucency that is both progressive and is greater than 3 mm at its maximum interface in two or more contiguous zones OR a bony destructive lesion that is progressive in nature.
- Migration/subsidence of any femoral or tibial component defined as a component migration/subsidence of > 3 mm as compared to 6 week radiographs.
- A component fracture
Measured: 2 years
Absence of Revision/Removal/Unanticipated Adverse Device Effect (UADE)
This is a binary endpoint in which a knee is either a "success" or "failure". To obtain a successful result, a knee must reach the 2 year upper window limit with the device intact and without a component revision/removal or a UADE.
Measured: 2 Years
The Knee Society Assessment Score
The Knee Society Assessment Score judges the parameters of pain, stability, and range of motion and flexion contracture, extension lag, and misalignment are deductions. The minimum score is 0 and maximum is 100, higher scores meaning a better outcome.
Measured: 2 Years
The Knee Society Function Score
The Knee Society Function Score considers walking distance and stair climbing, with deductions for walking aids. The minimum score is 0 and maximum is 100, higher scores meaning a better outcome.
Measured: 2 Year
Secondary outcomes (7)
Knee Society Assessment Score
The Knee Society Assessment Score judges the parameters of pain, stability, and range of motion and flexion contracture, extension lag, and misalignment are deductions. The minimum score is 0 and maximum is 100, higher scores meaning a better outcome.
Measured: Pre-operation (baseline), 6 weeks, 6 months, and annually thereafter until study completion
Knee Society Score Assessment for Bilateral Subjects
The Knee Society Assessment Score judges the parameters of pain, stability, and range of motion and flexion contracture, extension lag, and misalignment are deductions. The minimum score is 0 and maximum is 100, higher scores meaning a better outcome.
Measured: Pre-operation (baseline), 6 weeks, 6 months, and annually thereafter until study completion
Knee Society Function Score at All Timepoints
The Knee Society Function Score considers walking distance and stair climbing, with deductions for walking aids. The minimum score is 0 and maximum is 100, higher scores meaning a better outcome.
Measured: Pre-operation (baseline), 6 weeks, 6 months, and annually thereafter until study completion
Knee Society Function Score for Bilateral Subjects
The Knee Society Function Score considers walking distance and stair climbing, with deductions for walking aids. The minimum score is 0 and maximum is 100, higher scores meaning a better outcome.
Measured: Pre-operation (baseline), 6 weeks, 6 months, and annually thereafter until study completion
Oxford Knee Score
- 12-item self-report measure containing questions regarding the patient's pain and level of function
- The scoring system ranges from 0-4 on each question with 4 representing maximum function and 0 representing poorest function.
- Using this scale, the lowest, worst score is a 0, and the highest, best score is 48.
- The OKS has 2 subscales:
- Pain
- Function The pain component score (OKS-PCS) consists of items 2, 3, 7, 11 and 12, and the functional component score consists of items 1, 4, 5, 6, 8, 9, and 10.
Measured: Pre-operation (baseline), 6 weeks, 6 months, and annually thereafter until study completion
Number of Knees Which Met the Criteria for Radiographic Success
This is a binary endpoint in which a knee is either a "success" or "failure".
To obtain a successful radiographic endpoint, a knee must meet the following criteria at the 22+ month interval.
- Absence of osteolysis
- No migration/subsidence of any femoral or tibial component
- Absence of fractured component
Conversely, a radiographic failure is defined as follows:
- Presence of osteolysis defined as a radiolucency that is both progressive and is greater than 3 mm at its maximum interface in two or more contiguous zones OR a bony destructive lesion that is progressive in nature.
- Migration/subsidence of any femoral or tibial component defined as a component migration/subsidence of > 3 mm as compared to 6 week radiographs.
- A component fracture
Measured: Pre-operation (baseline), 6 weeks, 6 months, 1y, 3y, 4y, 5y, 6y, 7y
Patient Assessment of Satisfaction
At each postoperative assessment using the Analysis Windows, patients were asked to indicate their level of satisfaction with the operated knee. The potential outcomes were Very Satisfied, Satisfied, Uncertain and Unsatisfied.
Measured: 6 weeks, 6 months, and annually thereafter until study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2011 (estimated)
- Study startDec 2011
- Primary completion30 Nov 2020
- Study completion30 Nov 2021
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 Osteoarthritis, 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hillary Overholser, Study director, Zimmer Biomet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01473134
- Sponsor's protocol ID
- IDE: G100123
- Other IDs
- ORTHO.CR.US30
- Status last verified
- Sep 2024
- First submitted
- 9 Nov 2011
- Last updated
- 11 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No