Physica System Total Knee Replacement Registry Study

Part of paid clinical trials in Rancho Mirage, California.

Sponsor
Limacorporate S.p.a
Study ID
NCT03048201
Status
Recruiting
Apply to this trial

Conditions

  • Avascular Necrosis
  • Deformity of Knee
  • Degenerative Joint Disease of Knee
  • Osteoarthritis, Knee
  • Rheumatoid Arthritis
  • Traumatic Arthritis

Eligibility Criteria

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

Interventions

  • Physica Kinematic Retaining Knee System — DEVICE
    Modular total knee prosthesis with a Kinematic Retaining mechanism and posterior cruciate ligament (PCL) preservation
  • Physica Cruciate Retaining Knee System — DEVICE
    Total knee prosthesis with posterior cruciate ligament (PCL) preservation
  • Physica Posterior Stabilized Knee System — DEVICE
    Total knee prosthesis that sacrifices the posterior cruciate ligament (PCL) and replaces the functionality of the PCL with a post-cam mechanism.
  • Physica Cruciate Retaining Knee System with LMC Liner — DEVICE
    Total knee prosthesis with posterior cruciate ligament (PCL) preservation

Study Details

The primary objective of this study is to obtain long-term implant survivorship (out to 10 years) and to assess clinical, patient-reported outcome measures, and radiographic data for the commercially available Physica system. For ancillary arm, from baseline to 5-year follow-up.

Key Dates

Start date
Mar 24, 2017
Status verified
Mar 2023
Primary completion
Mar 31, 2030
Completion
Mar 31, 2030

Study Design

Enrollment
800 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Physica KR
    Subjects that receive the Physica Kinematic Retaining Knee System
  • Other: Physica CR
    Subjects that receive the Physica Cruciate Retaining Knee System
  • Other: Physica PS
    Subjects that receive the Physica Posterior Stabilized Knee System
  • Other: Physica CR with LMC Liner
    Subjects that receive the Physica Cruciate Retaining Knee System with LMC Liner

Primary Outcome Measure

Implant Survivorship [ Time Frame: 10 years ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Eisenhower Desert Orthopedics Center - Harry and Diane Rinker BldgRancho MirageCalifornia92270
Izzy Nunez
[email protected]
760-766-2540
Wendy Monaco
[email protected]
7607662540
Erik Schnaser, MD (PRINCIPAL_INVESTIGATOR)
Ghassan Boghosian, DO (PRINCIPAL_INVESTIGATOR)
The Orthopedics ClinicDaytona BeachFlorida32117
Mark Gillespy, MD
386-255-4596
Sherri Zicker
+1-386-255-4596
Mark Gillespy, MD (PRINCIPAL_INVESTIGATOR)
Rush Castle OrthopaedicsAuroraIllinois60504
Mark Schinsky, MD
630-978-3800
Renee Bergstrom
+1-630-978-3800
Mark Schinsky, MD (PRINCIPAL_INVESTIGATOR)
Syracuse Orthopedic SpecialistsSyracuseNew York13214-
Joint Reconstructive SpecialistOklahoma CityOklahoma73159-

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Eisenhower Desert Orthopedics Center - Harry and Diane Rinker Bldg· Rancho Mirage, CAThe Orthopedics Clinic· Daytona Beach, FLRush Castle Orthopaedics· Aurora, ILSyracuse Orthopedic Specialists· Syracuse, NYJoint Reconstructive Specialist· Oklahoma City, OK

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