Navigated EM Total Knee Replacement: Accuracy Study

NCT00512421 | Terminated

• 1 other identifier: LIB002-HMO-CTIL
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The use of computer-assisted surgery by orthopedic surgeons experienced in the performance of total knee arthroplasty may result in better overall limb and implant alignment and fewer outliers as compared with the findings after manual total knee arthroplasty. The alignment results in previous studies were based on radiographic measurements. The sensitivity of radiographic assessment of limb and implant alignment may not be significant enough to distinguish small differences between computer-assisted surgery and manual techniques. It is possible that alignment differences that were too minor to be exposed on standard radiographs might result in long-term differences in the durability of arthroplasties performed with use of computer-assisted surgery or manual techniques. Moreover it is possible to measure additional implant positioning parameters with computed tomography (CT) technology. In this study, the investigators would like to add new method, for accurate measurement of implant alignment and to correlate its results with clinical data.

Conditions

Total Knee Replacement

Study Arms (3)

A

navigation technique

Procedure: computer-assisted surgery

B

conservative surgery

Procedure: computer-assisted surgery

C

Historical control

Interventions

computer-assisted surgery PROCEDURE

A; B

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

men and women that are candidates for total knee replacement.

You may qualify if:

• Signing informed consent

You may not qualify if:

• Pregnancy
• Soldiers in active military service

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Orthopedic Department

Jerusalem, Israel

Location

MeSH Terms

Interventions

Surgery, Computer-Assisted

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Meir Libergall, Prof.

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 5, 2007
• First Posted: August 7, 2007
• Last Updated: September 16, 2011

Record last verified: 2011-08

Locations

IL (1)