A Comparative Study of Knee Systems

Phase 4

Completed

• Conditions: Osteoarthritis of the Knee
• Interventions: Procedure: Total Knee Arthroplasty with Custom Cutting Blocks; Procedure: Total Knee Arthroplasty via Computer Assisted Surgery

• Registration Number: NCT01331278
• Lead Sponsor: Foundation for Southwest Orthopedic Research

Brief Summary

The custom cutting guides personalized for each patient via pre-operative MRI will result in significantly faster intraoperative time with comparable knee alignment accuracy, cost, knee function, and patient satisfaction.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Primary Completion: 2010-08
• Study Completion: 2011-03
• Status Verified: 2011-04
• Study First Submitted: 2011-04-06
• Study First Submitted QC: 2011-04-07
• Last Update Submitted: 2011-04-07
• Study First Posted: 2011-04-08
• Last Update Posted: 2011-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• must be scheduled to undergo TKA with no bilateral TKA planned within 6 weeks of the initial surgery date
• must be 18 years of age or older
• must be capable and willing to provide informed consent
• must have flexion contracture less than 15 degrees.
• must have ligament stability no more than 2 degrees instability in varus/valgus extension stress

Exclusion Criteria

• medical condition or personal circumstances that will prevent participation and completion of the follow-up visits at 3 weeks, 6 weeks and 3 months post-op
• currently participating in or has participated in (within 30 days prior to inclusion in this study) another clinical trial of an investigational drug, biologic, device, or procedure
• known pre-operative systemic infections, uncontrolled diabetes, or diseases or conditions that are known to interfere with the wound healing process
• Knee alignment deformities greater than 7 degrees varus or valgus
• known prior knee revisions or previous surgeries deemed to compromise the TKA incision exposure
• known medical conditions prohibiting the use of MRI or nickel allergy, sensitivity, or hardware in the region of the knee

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Custom Cutting Blocks	Total Knee Arthroplasty with Custom Cutting Blocks	-
Computer Assisted Surgery	Total Knee Arthroplasty via Computer Assisted Surgery	-

Primary Outcome Measures

Name	Time	Method
mean intraoperative time	measured during surgery (day 1)	Time measured in pre-defined segments from the point that the patient is wheeled into the OR until the OR is clean and ready for the next case's activities to begin.

Secondary Outcome Measures

Name	Time	Method
alignment accuracy	3 weeks post-op

Trial Locations

Locations (2)

Southwest Orthopedic Group, LLP; 🇺🇸 Houston, Texas, United States

The Methodist Hospital; 🇺🇸 Houston, Texas, United States