Safety and Efficacy of the Oxford Cementless Partial Knee System

NCT01473134 | Completed Results FDA Device

• 2 other identifiers: IDE: G100123ORTHO.CR.US30
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 8

Brief 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. 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).

Conditions

Osteoarthritis, Knee; Avascular Necrosis of the Medial Femoral Condyle

Outcome Measures

Primary Outcomes (4)

• 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. 1. Absence of osteolysis 2. No migration/subsidence of any femoral or tibial component 3. Absence of fractured component Conversely, a radiographic failure is defined as follows: 1. 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. 2. Migration/subsidence of any femoral or tibial component defined as a component migration/subsidence of \> 3 mm as compared to 6 week radiographs. 3. A component fracture

  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.

  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.

  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.

  2 Year

Secondary Outcomes (7)

• Knee Society Assessment Score

  Pre-operation (baseline), 6 weeks, 6 months, and annually thereafter until study completion

• Knee Society Score Assessment for Bilateral Subjects

  Pre-operation (baseline), 6 weeks, 6 months, and annually thereafter until study completion

• Knee Society Function Score at All Timepoints

  Pre-operation (baseline), 6 weeks, 6 months, and annually thereafter until study completion

• Knee Society Function Score for Bilateral Subjects

  Pre-operation (baseline), 6 weeks, 6 months, and annually thereafter until study completion

• Oxford Knee Score

  Pre-operation (baseline), 6 weeks, 6 months, and annually thereafter until study completion

Study Arms (2)

Oxford Cementless Partial Knee

EXPERIMENTAL

Oxford Partial Knee implanted without bone cement.

Device: Oxford Cementless Partial Knee

Oxford Cemented Partial Knee

ACTIVE COMPARATOR

Oxford Partial Knee applied with bone cement.

Device: Oxford Cemented Partial Knee

Interventions

Oxford Cementless Partial Knee DEVICE

Oxford Partial Knee applied without bone cement.

Oxford Cementless Partial Knee

Oxford Cemented Partial Knee DEVICE

Oxford Partial Knee applied with bone cement.

Oxford Cemented Partial Knee

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (8)

Orthopedic & Sports Medicine Center of Northern Indiana, Inc.

Elkhart, Indiana, 46514, United States

Location

Midwest Center for Hip and Knee Surgery

Indianapolis, Indiana, 46241, United States

Location

Miller Orthopaedic Affiliates

Council Bluffs, Iowa, 51503, United States

Location

Twin City Orthopedics

Edina, Minnesota, 55435, United States

Location

OrthoCarolina

Huntersville, North Carolina, 28078, United States

Location

Joint Implant Surgeons, Inc

New Albany, Ohio, 43054, United States

Location

Texas Center for Joint Replacements

Plano, Texas, 75093, United States

Location

Anderson Orthopedic Clinic

Alexandria, Virginia, 22306, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Hillary Overholser
• Organization: Clinical Affairs Associate Director

hillary.overholser@zimmerbiomet.com

574-933-4180

Study Officials

• Hillary Overholser

  Zimmer Biomet

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2011
• First Posted: November 17, 2011
• Study Start: December 1, 2011
• Primary Completion: November 30, 2020
• Study Completion: November 30, 2021
• Last Updated: August 11, 2025
• Results First Posted: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)