Cementless Oxford Partial Knee Controlled Observational Study

NCT02350049 | Completed

• 1 other identifier: ORTHO.CR.GK10
• Study Type: observational
• Target: 391
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of the Cementless Oxford Partial Knee System.

Conditions

Osteoarthritis; Avascular Necrosis

Outcome Measures

Primary Outcomes (1)

• 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

  22+months

Secondary Outcomes (4)

• Survivorship (Cementless Only)

  22+ Months

• American Knee Society Score

  0-16 Week, 6 Month, 12 Month

• Oxford Knee Score

  0-16 Weeks, 6 Months, 12 Months, 22+ Months

• Adverse Events

  Through 22+ Months Postop

Study Arms (2)

Investigational

Cementless Medial Partial Knee

Control

Cemented Medial Partial Knee

Eligibility Criteria

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

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.

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Zimmer Biomet: lead

MeSH Terms

Conditions

Osteoarthritis; Osteonecrosis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Prof. David Murray, BA Hons, BChir, FRCS, MD

  Nuffield Orthopaedic Centre

  PRINCIPAL INVESTIGATOR

• Prof. Hemant Pandit, MBBS, MS, DNB, FRCS, DPhil

  Nuffield Orthopaedic Centre

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2014
• First Posted: January 29, 2015
• Study Start: November 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: April 1, 2017
• Last Updated: December 8, 2017

Record last verified: 2017-12