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

First listed
Feb 9, 2017
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-

Find similar trials in Rancho Mirage, CA

Nationwide
Rheumatoid arthritis trialsRheumatology trialsAutoimmune disease trialsMusculoskeletal disorders trials
By condition
Rheumatoid arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
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

Related Studies