Preoperative Alignment of Total Knee Replacement

VA Palo Alto Health Care System

Status and phase: Completed; Phase 3

Conditions: Knee Arthritis

Treatments: Procedure: control group; Procedure: trumatch group

Study type: Interventional

Funder types: Other U.S. Federal agency; Industry

Identifiers

NCT01242085

04061991

Details and patient eligibility

About

The hypothesis of this study is that total knee alignment will be improved by preoperative planning from CT scans and the production of custom instruments compared to the use of standard instruments.

Full description

Patients will be randomized to have either customized knee instruments or standard generic instrumentation for primary total knee replacement. Postoperative CT scan will be used to determine alignment of each group.

Enrollment: 64 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:patients undergoing primary total knee replacement -

Exclusion Criteria:patients who have hardware involving the hip, knee or ankle

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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64 participants in 2 patient groups

control group

Active Comparator group

Description:

control group will have standard instrumentation of their knee replacement

Treatment:

Procedure: control group

trumatch group

Experimental group

Description:

the trumatch patient will have custom instruments made from preop CT scans

Treatment:

Procedure: trumatch group