Clinical Outcomes Study of the Nexel Total Elbow

Part of paid clinical trials in Golden, Colorado.

Sponsor
Zimmer Biomet
Study ID
NCT02469662
Status
Recruiting
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Conditions

  • Acute Comminuted Articular Fracture of Elbow Joint Surfaces
  • Advanced Rheumatoid Arthritis
  • Ankylosed Joints
  • Bilateral Ankylosis From Causes Other Than Active Sepsis
  • Bone Loss Contributing to Elbow Instability
  • Degenerative Arthritis
  • Elbow Joint Destruction
  • Joint Instability or Loss of Motion
  • Post-traumatic Arthritis
  • Post-traumatic Lesions

Eligibility Criteria

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

Interventions

  • Nexel Total Elbow — DEVICE
    Nexel Total Elbow used in primary or revision total elbow arthroplasty

Study Details

The objectives of the study are to confirm safety and performance of the Zimmer Nexel Total Elbow when used in primary or revision total elbow replacement.

Key Dates

Start date
Jun 30, 2015
Status verified
Oct 2025
Primary completion
Dec 31, 2035
Completion
Dec 31, 2036

Study Design

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

Arms

  • Experimental: Retrospective
    Patients who have had primary or revision total elbow arthroplasty using the Nexel Total Elbow, and who have surgical details available
  • Experimental: Prospective
    Patients who are having primary or revision total elbow arthroplasty who will receive the Nexel Total Elbow

Primary Outcome Measure

Survivorship [ Time Frame: 10 years ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Panorama Orthopedics and Spine CenterGoldenColorado80401
David Schneider, MD (PRINCIPAL_INVESTIGATOR)
OrthoCarolina Research InstituteCharlotteNorth Carolina28207
Caleb Lifsey
[email protected]
704-323-2262
Justin Norwood
[email protected]
704-323-3845
Nady Hamid, MD (PRINCIPAL_INVESTIGATOR)
Patrick Connor, MD (SUB_INVESTIGATOR)
Rothman InstitutePhiladelphiaPennsylvania19107
Anuhya Peruri
[email protected]
267-386-2474
Thema Nicholson
[email protected]
Surena Namdari, MD (PRINCIPAL_INVESTIGATOR)
Matthew Ramsey, MD (SUB_INVESTIGATOR)
Campbell ClinicGermantownTennessee38138
Margaret Knack
[email protected]
Thomas W Throckmorton, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Golden, CO

By research site
Panorama Orthopedics and Spine Center· Golden, COOrthoCarolina Research Institute· Charlotte, NCRothman Institute· Philadelphia, PACampbell Clinic· Germantown, TN

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