Trial of Unicompartmental Versus Total Knee Arthroplasty | NCT03385759

Studies
Trial of Unicompartmental Versus Total Knee Arthroplasty

NCT03385759

Sponsor

Anderson Orthopaedic Research Institute

Status

Unknown status

Last Update Posted

Nov 14, 2022Actual

Enrollment

112Estimated

Phase

Not Applicable

Conditions

Osteo Arthritis Knee

Interventions

Unicompartmental knee arthroplasty
Total knee arthroplasty

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 22, 2018Actual

Primary Completion Date

Apr 1, 2023Estimated

Completion Date

Jan 2025Estimated

First Submitted Date

Dec 21, 2017

First Submission Date that Met QC Criteria

Dec 27, 2017

First Posted Date

Dec 28, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 9, 2022

Last Update Posted Date

Nov 14, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Nancy Parks, Sr. Project Director, Anderson Orthopaedic Research InstitutePrincipal Investigator

Lead Sponsor

Anderson Orthopaedic Research InstituteOTHER

Collaborators

Name	Class
Rush University Medical Center	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is a prospective, randomized trial to compare patient outcomes of unicompartmental knee arthroplasty (UKA) and total knee arthroplasty (TKA) for the treatment of medial compartment osteoarthritis.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

112Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
UKA	Active Comparator	Medial unicompartmental knee arthroplasty	Procedure: Unicompartmental knee arthroplasty
TKA	Active Comparator	Total knee arthroplasty	Procedure: Total knee arthroplasty

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Unicompartmental knee arthroplasty	Procedure	Implant to replace the medial compartment of a patient with knee osteoarthritis	UKA

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Knee Society Score	Functional outcome questionnaire ranging from 0-100, with 100 being best	1 year
Knee Society Score	Functional knee outcome questionnaire ranging from 0-100, with 100 being best	2 years

Secondary Outcomes

Measure	Description	Time Frame
Revision	complication requiring revision surgery	2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

medial compartment osteoarthritis of the knee
knee flexion greater than greater than 90 degrees
flexion contracture of less than 10 degrees
varus deformity < 20 degrees
grade IV degeneration of the medial compartment

Exclusion Criteria:

lateral compartment degenerative changes
previous lateral meniscectomy
anterior cruciate ligament deficiency
body mass index > 40
inflammatory arthritis
history of septic arthritis
hemoglobin A1c > 8.0
chronic liver disease
stage 3A or greater chronic renal disease
active IV drug abuse
patients requiring thromboembolic prophylaxis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kevin Fricka, MD	Anderson Orthopaedic Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rush University Medical Center		Chicago	Illinois	60612	United States
Anderson Orthopaedic Research Institute

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010003	Osteoarthritis

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019645	Arthroplasty, Replacement, Knee

Ancestor Terms

ID	Term
D019643	Arthroplasty, Replacement
D001178	Arthroplasty
D019637	Orthopedic Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided