NCT01797731

Brief Summary

This is a randomized, controlled, blinded prospective study comparing the use of the usual cutting guides with a palm-sized digital surgical navigation system in unilateral total knee arthroplasty. Analysis of pre- and post-operative X-rays will be used to compare alignment of the tibial (shinbone) implant components. The investigators expect that the FDA-approved hand-held surgical navigation device will increase the accuracy and precision of the tibial cut by telling the surgeon the exact position of the cutting block before the surgeon makes the cut, allowing minor adjustments to be made. The investigators expect the conventional device to take less time to use, but that this difference will decrease as the surgeon becomes more familiar with the device. The investigators expect the intraoperative measurements acquired by the KneeAlign system to strongly correlate with the radiographic alignments measured postoperatively.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2010

Typical duration for not_applicable

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

December 1, 2010

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

February 7, 2013

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 22, 2013

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2013

Completed
3.8 years until next milestone

Results Posted

Study results publicly available

July 11, 2017

Completed
Last Updated

July 11, 2017

Status Verified

July 1, 2017

Enrollment Period

2.2 years

First QC Date

February 7, 2013

Results QC Date

March 28, 2017

Last Update Submit

July 10, 2017

Conditions

Osteoarthritis, Knee

Keywords

OrthalignKneeAlignTotal Knee ReplacementTotal Knee ArthroplastyDegenerative joint diseaseOsteoarthritisUnilateral

Outcome Measures

Primary Outcomes (1)

  • Postoperative Tibial Component Alignment

    The primary outcome will be the number of patients (percentage of patients) that met a predetermined criteria for Alignment as defined by within 2° of perpendicular to the tibial mechanical axis or 2° of a 3° posterior slope, postoperative tibial component alignment (mechanical varus/valgus, and posterior slope) as measured on postoperative standing anteroposterior hip-to-ankle radiographs, and standing, lateral knee-to-ankle radiographs, respectively.

    6 weeks after surgery

Secondary Outcomes (1)

  • Time Required to Utilize System

    Minutes during surgery ( Estimated time per surgery 1 hour)

Study Arms (2)

Conventional System

ACTIVE COMPARATOR

Conventional tibial extramedullary alignment system used by surgeon during surgery.

Device: Conventional tibial extramedullary alignment system

KneeAlign System

EXPERIMENTAL

Digital hand-held surgical navigation system for tibial component placement used by surgeon during surgery.

Device: Digital hand-held surgical navigation system

Interventions

Digital hand-held surgical navigation systemDEVICE

Digital hand-held surgical navigation system used for tibial component placement in total knee arthroplasty

Also known as: KneeAlign, OrthAlign
KneeAlign System
Conventional tibial extramedullary alignment systemDEVICE

This is the standard of care for total knee arthroplasty.

Conventional System

Eligibility Criteria

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

You may qualify if:

  • a history of osteoarthritis, rheumatoid arthritis, or post-traumatic arthritis
  • patients who have been indicated for a primary, posterior-stabilized, total knee arthroplasty
  • patients have had a preoperative standing anteroposterior hip-to-ankle radiograph and standing lateral knee-to-ankle radiographs

You may not qualify if:

  • patients with proximal tibial defects requiring either a metal or allograft augment
  • inadequate radiographic studies as required by the study protocol
  • if they do not receive a total knee arthroplasty, or receive a unicondylar arthroplasty

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Related Publications (5)

  • Nam D, Weeks KD, Reinhardt KR, Nawabi DH, Cross MB, Mayman DJ. Accelerometer-based, portable navigation vs imageless, large-console computer-assisted navigation in total knee arthroplasty: a comparison of radiographic results. J Arthroplasty. 2013 Feb;28(2):255-61. doi: 10.1016/j.arth.2012.04.023. Epub 2012 Jun 14.

    PMID: 22704226RESULT

  • Nam D, Jerabek SA, Cross MB, Mayman DJ. Cadaveric analysis of an accelerometer-based portable navigation device for distal femoral cutting block alignment in total knee arthroplasty. Comput Aided Surg. 2012;17(4):205-10. doi: 10.3109/10929088.2012.689335. Epub 2012 Jun 8.

    PMID: 22681247RESULT

  • Nam D, Nawabi DH, Cross MB, Heyse TJ, Mayman DJ. Accelerometer-based computer navigation for performing the distal femoral resection in total knee arthroplasty. J Arthroplasty. 2012 Oct;27(9):1717-22. doi: 10.1016/j.arth.2012.02.007. Epub 2012 Mar 21.

    PMID: 22440228RESULT

  • Nam D, Dy CJ, Cross MB, Kang MN, Mayman DJ. Cadaveric results of an accelerometer based, extramedullary navigation system for the tibial resection in total knee arthroplasty. Knee. 2012 Oct;19(5):617-21. doi: 10.1016/j.knee.2011.09.008. Epub 2011 Oct 26.

    PMID: 22032868RESULT

  • Nam D, Jerabek SA, Haughom B, Cross MB, Reinhardt KR, Mayman DJ. Radiographic analysis of a hand-held surgical navigation system for tibial resection in total knee arthroplasty. J Arthroplasty. 2011 Dec;26(8):1527-33. doi: 10.1016/j.arth.2011.01.012. Epub 2011 Mar 11.

    PMID: 21397455RESULT

MeSH Terms

Conditions

Osteoarthritis, KneeJoint DiseasesOsteoarthritis

Condition Hierarchy (Ancestors)

ArthritisMusculoskeletal DiseasesRheumatic Diseases

Results Point of Contact

Title
David Mayman
Organization
Hospital for Special Surgery
maymand@hss.edu
2127742024

Study Officials

  • David Mayman, MD

    Hospital for Special Surgery, New York

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2013

First Posted

February 22, 2013

Study Start

December 1, 2010

Primary Completion

March 1, 2013

Study Completion

September 16, 2013

Last Updated

July 11, 2017

Results First Posted

July 11, 2017

Record last verified: 2017-07

Locations

US(1)