NCT02175576

Brief Summary

Randomized Controlled Study to determine if preservation of ligaments provides increased functional ability post-operatively in comparison to traditional TKA which sacrifices soft tissue.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
terminated

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

First Submitted

Initial submission to the registry

June 24, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 26, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

February 21, 2023

Completed
Last Updated

February 21, 2023

Status Verified

February 1, 2023

Enrollment Period

6.2 years

First QC Date

June 24, 2014

Results QC Date

January 18, 2023

Last Update Submit

February 16, 2023

Conditions

OsteoarthritisRheumatoid ArthritisTraumatic ArthritisLower Limb DeformityPost-traumatic DeformityComplications, Arthroplasty

Outcome Measures

Primary Outcomes (1)

  • Number of Knees Reported as "Feels Normal" on a Single Assessment Numeric Evaluation (SANE)

    Participants answered a Single Assessment Numeric Evaluation (SANE) which asked how they rated their knee function. A score of 100 indicates normal and anything below 100 indicates a percentage of normal function.

    12 Months

Secondary Outcomes (4)

  • Modified Knee Society Score

    12 months

  • Revisions/Removals

    3 years

  • Number of Knees Reported as "Feels at Least 80% of Normal" on a Single Assessment Numeric Evaluation (SANE)

    12 Months

  • Number of Knees With Which Participants Reported Being "Happy" or "Very Happy"

    12 Months

Study Arms (2)

Vanguard XP Bicruciate Knee System

EXPERIMENTAL

153 patients receive Vanguard XP Bicruciate Knee System

Device: Vanguard XP Bicruciate Knee System

Vanguard CR Knee System

ACTIVE COMPARATOR

153 patients receive Vanguard CR Knee System

Device: Vanguard CR Knee System

Interventions

Vanguard XP Bicruciate Knee SystemDEVICE

The Vanguard XP is a bicruciate retaining total knee design and is constrained by natural soft tissue.

Vanguard XP Bicruciate Knee System
Vanguard CR Knee SystemDEVICE

The Vanguard CR system requires the ACL to be sacrificed and is constrained by soft tissue and device design.

Vanguard CR Knee System

Eligibility Criteria

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

You may qualify if:

  • cemented application of components
  • bilateral subjects randomized by knee
  • patients with pre-existing contralateral knee surgery
  • painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, or traumatic arthritis where one or more compartments are involved
  • correction of varus, valgus, or posttraumatic deformity
  • sufficient soft tissue surrounding the knee, including the Anterior Cruciate Ligament

You may not qualify if:

  • cementless application of components
  • BMI greater than or equal to 40
  • use of Anterior Stabilized Bearings
  • patients with severe pre-operative varus or valgus deformity greater than or equal to 15 degrees
  • correction or revision of previous joint replacement procedure on index knee
  • infection
  • sepsis
  • osteomyelitis
  • uncooperative patient or patient with neurological disorders who is incapable of following directions
  • osteoporosis
  • metabolic disorders which may impair bone formation
  • osteomalacia
  • distant foci of infections which may spread to the implant site
  • rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram
  • vascular insufficiency, muscular atrophy, neuromuscular disease
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Midwest Orthopaedics at Rush University Medical Center

Chicago, Illinois, 60605, United States

Location

University of Utah Orthopaedic Center

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Conditions

OsteoarthritisArthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed.

Results Point of Contact

Title
Hillary Overholser
Organization
Zimmer Biomet
hillary.overholser@zimmerbiomet.com
574-933-4180

Study Officials

  • Hillary Overholser

    Zimmer Biomet

    STUDY DIRECTOR

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
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2014

First Posted

June 26, 2014

Study Start

October 1, 2014

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

February 21, 2023

Results First Posted

February 21, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

US(2)