A Comparative Study of Knee Systems

Osteoarthritis of the Knee Clinical Trial

— Bake-Off  

Official title:

A Comparative Study of Knee Systems Employing Personalized Computer Generated Cutting Guides for Total Knee Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01331278
• Other study ID #: 0509-0060
• Status: Completed
• Phase: Phase 4
• First received: April 6, 2011
• Last updated: April 7, 2011
• Start date: September 2009
• Est. completion date: March 2011

Study information

• Verified date: April 2011
• Source: Foundation for Southwest Orthopedic Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: The Methodist Hospital research Institute Institutional Review BoardUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2011
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

Procedure:
• Total Knee Arthroplasty with Custom Cutting Blocks
Subjects randomized to this study group will undergo TKA with patient specific custom cutting blocks generated by pre-op MRI and a Biomet Vanguard knee implant
• Total Knee Arthroplasty via Computer Assisted Surgery
Subjects randomized to this study group will receive TKA via computer assisted surgery and a Biomet Vanguard knee implant

Locations

Country	Name	City	State
United States	Southwest Orthopedic Group, LLP	Houston	Texas
United States	The Methodist Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Foundation for Southwest Orthopedic Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean intraoperative time	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.	measured during surgery (day 1)	No
Secondary	alignment accuracy		3 weeks post-op	No