Study: Elbow Instability Repair PRUJ

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 RADIOULNAR JOINT DISORDERS

Study Investigator: F. Thomas D. Kaplan, MD

What is the study?

This study is an elbow instability surgery study being conducted for an institutional sponsor to assess the safety and efficacy of a new investigational prosthesis for the treatment of proximal radioulnar joint disorders.

Subject follow-up evaluations will occur at Baseline, at Weeks 2, 6, 12, and 24 as well as 1 and 2 years post-surgery.

Are you eligible to participate in this study?

Inclusion Criteria:

Skeletally mature and under 85 years of age

Painful, unstable elbow or post-traumatic disabilities of the elbow

Exclusion Criteria:

Allergy to nickel or other implant materials
Chronic corticosteroid use
BMI higher than 45 kg/m²
Neuromuscular deficiencies

There are additional eligibility criteria that can be screened by your doctor if you meet the above.

What do you need to know?

Participation in research is entirely voluntary. If you think you qualify to be part of this study, ask your doctor about participation.

Please contact Lexie Reissaus, Clinical Research Manager at lreissaus@ihtsc.com.

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