Early Outcome Assessment of Revision Total Knee Arthroplasty Using Metaphyseal Sleeves

Revision Total Knee Replacement Clinical Trial

Official title:

Early Outcome Assessment of Revision Total Knee Arthroplasty Using Metaphyseal Sleeves

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01156558
• Other study ID #: 10FA01
• Status: Completed
• Phase: N/A
• First received: July 1, 2010
• Last updated: March 30, 2011
• Start date: June 2010
• Est. completion date: July 2010

Study information

• Verified date: March 2011
• Source: Rothman Institute Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Revision knees with bone defect for which metaphyseal sleeve in femoral and/or tibial side is used

2. Cases with at least 2 year follow-up

3. Cases with regular follow-up visits completed

Exclusion Criteria:

1. Cemented sleeves

2. Patients with less than two year follow-up completed

3. Cases lost to follow-up

Related Conditions & MeSH terms

• Revision Total Knee Replacement

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Rothman Institute Orthopaedics	DePuy Orthopaedics

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implant survivorship 2 years following revision TKA
Secondary	Knee Society Score
Secondary	KOOS score
Secondary	Radiographic assessment 1 and 2 years following revision surgery