Early Outcome Assessment of Revision Total Knee Arthroplasty Using Metaphyseal Sleeves

NCT01156558 | Completed

• 1 other identifier: 10FA01
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Metaphyseal sleeves, through their design, could allow reconstruction of the knee in cases of severe bone loss by allowing rigid internal fixation and proper alignment of the extremity and components.

Conditions

Revision Total Knee Replacement

Outcome Measures

Primary Outcomes (1)

• Implant survivorship 2 years following revision TKA

Secondary Outcomes (3)

• Knee Society Score

• KOOS score

• Radiographic assessment 1 and 2 years following revision surgery

Eligibility Criteria

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

Study Population

Sequential assessment of 100 patients who have received a revision knee surgery for which metaphyseal sleeve was used in femoral and/or tibial side starting August 2007. Patients must meet inclusion/exclusion criteria for enrollment.

You may qualify if:

• Revision knees with bone defect for which metaphyseal sleeve in femoral and/or tibial side is used
• Cases with at least 2 year follow-up
• Cases with regular follow-up visits completed

You may not qualify if:

• Cemented sleeves
• Patients with less than two year follow-up completed
• Cases lost to follow-up

Sponsors & Collaborators

• Rothman Institute Orthopaedics: lead
• DePuy Orthopaedics: collaborator

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 1, 2010
• First Posted: July 5, 2010
• Study Start: June 1, 2010
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: March 31, 2011

Record last verified: 2011-03