Knee Arthroplasty Performed With Conventional and Customized Instrumentation

Knee Arthritis Clinical Trial

— CPI  

Official title:

A Prospective, Randomized Evaluation of Total Knee Arthroplasty Performed With Conventional and Customized Patient Instrumentation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01124305
• Other study ID #: AORI2010-0101
• Status: Completed
• Phase: Phase 4
• First received: May 12, 2010
• Last updated: November 25, 2013
• Start date: May 2010
• Est. completion date: November 2012

Study information

• Verified date: November 2013
• Source: Anderson Orthopaedic Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The main purpose of this study is to determine whether the surgical time required for primary total knee arthroplasty is significantly less when performed with Customized Patient Instrumentation (CPI) than with conventional instrumentation. Each case will be recorded by video camera, in order to time the length of surgery and each surgical step. The number of surgical trays required for each case will be recorded. As an additional endpoint, the investigators will measure limb and component alignment on x-rays to determine if these two methods achieve equivalent alignment results. The thickness of bone cuts will be compared to the surgical plan and to each other.

The primary hypothesis is that the use of customized patient instrumentation will reduce the operative time required for total knee arthroplasty.

Description:

Patient-specific instrumentation (PSI) has been developed for total knee arthroplasty (TKA) with several potential advantages over traditional instrumentation (TI). Shortened surgical time, fewer surgical instruments, and improved alignment are some of these proposed advantages. We sought to examine these assertions.

52 patients (26 per group) were enrolled in a prospective, randomized trial comparing CT-based PSI with TI. No difference was seen in average patient age (68 years) or BMI (31) between groups (p=0.84 and p=0.89), although there were more males in the PSI group (14 vs 7, p=0.002). A single surgeon and consistent staff performed the surgeries with the same knee prostheses, and all cases were videotaped to measure the length of surgery and each individual step. Any additional bone cuts, size changes, or ligament releases made to achieve correct alignment and balance were documented. The number of instrument trays opened for each case was recorded. Postoperative long alignment and lateral radiographs were taken to measure the coronal and sagittal plane component alignment and mechanical axis in each patient.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: November 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patient requires unilateral primary total knee arthroplasty

Exclusion Criteria:

• Body mass index greater than 41

• Previous ipsilateral hip or ankle replacement

• Knee flexion contracture greater than 20 degrees

Study Design

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

Related Conditions & MeSH terms

• Knee Arthritis

Intervention

Device:
• Customized Patient Instrumentation
Custom cutting guides based on computed tomography (CT) images of the patient's leg are used to make the bone cuts and select the implant size.
• Traditional Instrumentation
Traditional surgical instruments will be used to make bone cuts and size the components in this control group.

Locations

Country	Name	City	State
United States	Anderson Orthopaedic Research Institute	Alexandria	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Anderson Orthopaedic Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (5)

Bali K, Walker P, Bruce W. Custom-fit total knee arthroplasty: our initial experience in 32 knees. J Arthroplasty. 2012 Jun;27(6):1149-54. doi: 10.1016/j.arth.2011.12.006. Epub 2012 Jan 27. — View Citation

Howell SM, Kuznik K, Hull ML, Siston RA. Results of an initial experience with custom-fit positioning total knee arthroplasty in a series of 48 patients. Orthopedics. 2008 Sep;31(9):857-63. — View Citation

Lombardi AV Jr, Berend KR, Adams JB. Patient-specific approach in total knee arthroplasty. Orthopedics. 2008 Sep;31(9):927-30. — View Citation

Ng VY, DeClaire JH, Berend KR, Gulick BC, Lombardi AV Jr. Improved accuracy of alignment with patient-specific positioning guides compared with manual instrumentation in TKA. Clin Orthop Relat Res. 2012 Jan;470(1):99-107. doi: 10.1007/s11999-011-1996-6. — View Citation

Watters TS, Mather RC 3rd, Browne JA, Berend KR, Lombardi AV Jr, Bolognesi MP. Analysis of procedure-related costs and proposed benefits of using patient-specific approach in total knee arthroplasty. J Surg Orthop Adv. 2011 Summer;20(2):112-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of Surgery	Time elapsed from skin incision to wound closure (in seconds)	1 day	No
Secondary	Length of Each Surgical Step (in Seconds)	surgical exposure, tibial alignment and resection, femoral distal cut, extension gap balancing, sizing the femur, 4 finishing femoral cuts, posterior releases, patellar resection, trial components, tibial tray preparation, cleanup/ prep for cement, cementing femur, cementing tibia, cementing patella, and closure	1 day	No
Secondary	Number of Instrument Trays Required		1 day	No
Secondary	Limb Alignment (Mechanical Axis)	Alignment is measured on 4 month postoperative radiograph in degrees. The goal is a mechanical axis between and femur and tibia of 0 degrees. Varus alignment ("bow-legged") is shown as a negative number in degrees away from 0. Valgus alignment ("Knock-kneed") is expressed as a positive number in degrees away from 0.	4 months	No