Aptis PRUJ Prosthesis for the Treatment of Patients With Proximal Radial Ulna Joint Disorders.

Part of paid clinical trials in Carmel, Indiana.

Sponsor
Aptis Medical
Study ID
NCT05796908
Status
Recruiting

Conditions

  • Arthritis
  • Decreased Motion at the Proximal Radioulnar Joint and/or the Radio-humeral Joint
  • Proximal Radioulnar Joint Instability
  • Unstable Radial Head

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Accepted

Interventions

  • Aptis PRUJ Prosthesis — DEVICE
    A prosthetic implant for replacement of the proximal radial ulna joint.

Study Details

A Prospective, Multi-Center, Single-Arm Clinical Trial of the safety and effectiveness of the Aptis PRUJ prosthesis for the treatment of patients with proximal radial ulna joint disorders

Key Dates

Start date
Apr 12, 2024
Status verified
Jun 2026
Primary completion
Nov 30, 2029
Completion
Nov 30, 2030

Study Design

Enrollment
84 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Aptis PRUJ Prothesis
    Investigational Aptis PRUJ Prothesis treatment

Primary Outcome Measure

Sucess [ Time Frame: 24 months ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Indiana Hand to Shoulder CenterCarmelIndiana46260
Melanie Glover
317-802-2880
Kleinert Kutz Hand Care CenterLouisvilleKentucky40202
Ann Jerde
502-852-5251
Massachusetts General HospitalBostonMassachusetts02114
John Fitzhenry
617-726-1569
Orthopedic Associates of Southwest OhioDaytonOhio45459
Laura Peterson
937-439-6483
Lehigh Valley Health NetworkAllentownPennsylvania18103
Danielle Koehler
610-402-1657
University of Pennsylvania Perelman School of MedicinePhiladelphiaPennsylvania19104-
Medical College of WisconsinMilwaukeeWisconsin53226
Steven Liss
414-955-3218
John Gardner
+44 7345 02 3334

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