Cementless Oxford Partial Knee Controlled Observational Study

Osteoarthritis Clinical Trial

— GK10  

Official title:

Cementless Oxford Partial Knee Retrospective and Prospective Controlled Multi-center Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02350049
• Other study ID #: ORTHO.CR.GK10
• Status: Completed
• Phase: N/A
• First received: July 15, 2014
• Last updated: December 7, 2017
• Start date: November 2014
• Est. completion date: April 2017

Study information

• Verified date: December 2017
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 391
• Est. completion date: April 2017
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• 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

Related Conditions & MeSH terms

• Avascular Necrosis
• Necrosis
• Osteoarthritis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Survivorship (Cementless Only)	Minimum 1,000 cases to assess survivorship of cementless components	22+ Months
Secondary	American Knee Society Score	Assessment of Function and Range of Motion; retrospective study- data will be collected if available	0-16 Week, 6 Month, 12 Month
Secondary	Oxford Knee Score	Retrospective study; data will be collected if available.	0-16 Weeks, 6 Months, 12 Months, 22+ Months
Secondary	Adverse Events		Through 22+ Months Postop