A Multicenter Study to Evaluate Functional Outcome After Knee Replacement

Part of paid clinical trials in La Jolla, California.

Sponsor
Restor3D
Study ID
NCT02494544
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Off the Shelf Total Knee Replacement — DEVICE
    A knee replacement system by DePuy, Zimmer, Biomet, Smith \& Nephew, or Stryker
  • ConforMIS iTotal Knee Replacement — DEVICE
    A knee replacement performed with patient specific implant and surgical jigs.

Study Details

Patients will be consecutively enrolled by implant. Implant groups will be those who have undergone surgery with either a ConforMIS iTotal® CR TKA or an Off-the- Shelf (OTS) system. The patient will conduct functional testing and answer questionnaires. The results will compare the ConforMIS iTotal with an Off the Shelf Knee replacement.

Key Dates

Start date
Jul 1, 2015
Status verified
Nov 2025
Primary completion
Nov 16, 2022
Completion
Nov 16, 2022

Study Design

Enrollment
215 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE

Arms

  • Active Comparator: ConforMIS iTotal Knee replacement
    iTotal patient-specific knee replacement system
  • Active Comparator: DePuy total knee replacement
    Off the shelf knee replacement system
  • Active Comparator: Zimmer total knee replacement
    Off the shelf knee replacement system
  • Active Comparator: Biomet total knee replacement
    Off the shelf knee replacement system
  • Active Comparator: Smith & Nephew total knee replacement
    Off the shelf knee replacement system
  • Active Comparator: Stryker total knee replacement
    Off the shelf knee replacement system

Primary Outcome Measure

Functional Activities Subscale Score Within the Knee Society Score (KSS) Measure [ Time Frame: 1 year ]

Locations (8)

FacilityCityStateZIPSite coordinators
University of California in San DiegoLa JollaCalifornia92037-
Sharp HealthcareSan DiegoCalifornia92123-
Denver-Vail OrthopedicsParkerColorado80134-
Yale School of MedicineNew HavenConnecticut06520-
Tufts UniversityBostonMassachusetts02111-
University of MissouriColumbiaMissouri65212-
OrthoNYAlbanyNew York12205-
The Lindner Center for Research and EducationCincinnatiOhio45219-

Find similar trials in La Jolla, CA

By condition
Osteoarthritis (other)
By specialty
OrthopedicsMusculoskeletal disorders
By research site
University of California in San Diego· La Jolla, CASharp Healthcare· San Diego, CADenver-Vail Orthopedics· Parker, COYale School of Medicine· New Haven, CTTufts University· Boston, MAUniversity of Missouri· Columbia, MO

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