NCT02579174

Brief Summary

  1. 1.To determine whether the low-dose, biplanar x-ray imaging (EOS) has the same accuracy as computed axial tomography (CT)
  2. 2.To validate low-dose, biplanar x-ray imaging (EOS) as a tool to evaluate 3-dimensional alignment of Total Knee Replacement implants.
  3. 3.To evaluate differences in total knee replacement implant alignment in patients whose arthroplasty is performed using manual or custom instrumentation derived from preoperative CT

Trial Health

87
On Track

Trial Health Score

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

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 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

January 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 13, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 19, 2015

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 8, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
2 years until next milestone

Results Posted

Study results publicly available

November 15, 2022

Completed
Last Updated

November 15, 2022

Status Verified

October 1, 2022

Enrollment Period

5.7 years

First QC Date

October 13, 2015

Results QC Date

June 23, 2022

Last Update Submit

October 24, 2022

Conditions

Osteoarthritis of Knee

Outcome Measures

Primary Outcomes (1)

  • Post-Operative Hip-Knee-Angle (HKA)

    Measured HKA change from pre-operative EOS longstanding X-ray to post-operative EOS at 6wks. comparing groups receiving manual instrumentation versus custom instrumentation

    Pre-operative, 6 wks. post-op

Secondary Outcomes (3)

  • Tibial Varus Deformity

    Pre-operative, 6 wks. post-op

  • Femoral Valgus Deformity

    Pre-operative, 6 wks. post-op

  • Tibial Posterior Slope (Mean Deviation)

    Pre-Operative - 6 wk. Post-Operative

Study Arms (4)

Manual (tibia) and manual (femur)

OTHER

Knee replacement with Medacta GMK Sphere implants using manual instrumentation for both the tibia component and the femur component

Device: Medacta GMK Sphere

Manual (tibia) and custom (femur)

OTHER

Knee replacement with Medacta GMK Sphere implants using manual instrumentation for the tibia component and custom instrumentation for the femur component

Device: Medacta GMK Sphere

Custom (tibia) and custom (femur)

OTHER

Knee replacement with Medacta GMK Sphere implants using custom instrumentation for both the tibia component and the femur component

Device: Medacta GMK Sphere

Custom (tibia) and manual (femur)

OTHER

Knee replacement with Medacta GMK Sphere implants using custom instrumentation for the tibia component and manual instrumentation for the femur component

Device: Medacta GMK Sphere

Interventions

Medacta GMK SphereDEVICE
Custom (tibia) and custom (femur)Custom (tibia) and manual (femur)Manual (tibia) and custom (femur)Manual (tibia) and manual (femur)

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Radiographically confirmed diagnosis of osteoarthritis (OA)
  • Failure of non-operative treatment for the diagnosis of symptomatic osteoarthritis
  • Age greater than 18 years
  • Desire to proceed with elective TKR
  • Completion of informed consent and signature of written consent form

You may not qualify if:

  • Ligamentous instability that may necessitate a constrained TKR implant
  • Retained hardware in the distal femur or proximal tibia of the operative extremity
  • Medical contraindication to undergo preoperative CT, or inability to tolerate preoperative CT

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern Medicine Department of Orthopaedic Surgery

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Results Point of Contact

Title
Melissa Shauver, MPH
Organization
Northwestern University
melissa.shauver1@nm.org
312-472-6024

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 13, 2015

First Posted

October 19, 2015

Study Start

January 1, 2015

Primary Completion

September 8, 2020

Study Completion

November 30, 2020

Last Updated

November 15, 2022

Results First Posted

November 15, 2022

Record last verified: 2022-10

Locations

US(1)