NCT01124305

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2010

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

May 12, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 17, 2010

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
3 months until next milestone

Results Posted

Study results publicly available

January 21, 2013

Completed
Last Updated

December 18, 2013

Status Verified

November 1, 2013

Enrollment Period

2.2 years

First QC Date

May 12, 2010

Results QC Date

October 18, 2012

Last Update Submit

November 25, 2013

Conditions

Knee Arthritis

Keywords

Total Knee ArthroplastyInstrumentation

Outcome Measures

Primary Outcomes (1)

  • Length of Surgery

    Time elapsed from skin incision to wound closure (in seconds)

    1 day

Secondary Outcomes (3)

  • Length of Each Surgical Step (in Seconds)

    1 day

  • Number of Instrument Trays Required

    1 day

  • Limb Alignment (Mechanical Axis)

    4 months

Study Arms (2)

Traditional Instrumentation

ACTIVE COMPARATOR

Control group: Cases performed with traditional surgical instruments

Device: Traditional Instrumentation

Customized Patient Instrumentation

EXPERIMENTAL

Experimental group: Cases performed with custom instruments specifically made for each patient using pre-op CT scans.

Device: Customized Patient Instrumentation

Interventions

Customized Patient InstrumentationDEVICE

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.

Customized Patient Instrumentation
Traditional InstrumentationDEVICE

Traditional surgical instruments will be used to make bone cuts and size the components in this control group.

Traditional Instrumentation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patient requires unilateral primary total knee arthroplasty

You may not qualify if:

  • Body mass index greater than 41
  • Previous ipsilateral hip or ankle replacement
  • Knee flexion contracture greater than 20 degrees

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anderson Orthopaedic Research Institute

Alexandria, Virginia, 22306, United States

Location

Related Publications (5)

  • Lombardi AV Jr, Berend KR, Adams JB. Patient-specific approach in total knee arthroplasty. Orthopedics. 2008 Sep;31(9):927-30. doi: 10.3928/01477447-20080901-21. No abstract available.

    PMID: 18814618BACKGROUND

  • 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.

    PMID: 21809150BACKGROUND

  • 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. doi: 10.3928/01477447-20080901-15.

    PMID: 18814593BACKGROUND

  • 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.

    PMID: 22285230BACKGROUND

  • 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.

    PMID: 21838072BACKGROUND

Results Point of Contact

Title
Knee Project Director
Organization
AORI
nparks@aori.org
7036194423

Study Officials

  • William G Hamilton, MD

    Anderson Orthopaedic Research Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Knee Project Director

Study Record Dates

First Submitted

May 12, 2010

First Posted

May 17, 2010

Study Start

May 1, 2010

Primary Completion

July 1, 2012

Study Completion

November 1, 2012

Last Updated

December 18, 2013

Results First Posted

January 21, 2013

Record last verified: 2013-11

Locations

US(1)