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
This is 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. A total of 84 patients will be enrolled in this trial with 9 centers participating in the US. The total study duration will be approximately 36 months, with an enrollment period of 12 months, followed by a 24 month follow-up period. Annual visits will continue until the last patient reaches the 2-year post-operative time point.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
84
A prosthetic implant for replacement of the proximal radial ulna joint.
Indiana Hand to Shoulder Center
Carmel, Indiana, United States
RECRUITINGKleinert Kutz Hand Care Center
Louisville, Kentucky, United States
RECRUITINGMassachusetts General Hospital
Boston, Massachusetts, United States
Sucess
A non-inferiority composite primary endpoint for effectiveness and safety, where a subject is considered a success if they meet the following criteria: * Mayo Elbow Performance Score, where success is defined as Good or Excellent at 24 months; and * Absence of radiographic evidence of periprosthetic osteolysis (radiolucent line \>2mm around entire radial stem and ulnar screws), and no screw breakage at 24 months; and * Absence of device-related serious adverse events including any revisions and removals through 24 months
Time frame: 24 months
Effectiveness
The following secondary endpoints will evaluate the effectiveness of the investigational device: * Pre- vs. Post-operative function assessed via Mayo Elbow Performance Score * Mayo Subscores * Pain * Range of motion * Instability * Function
Time frame: 6 weeks, 3 months, 6 months, 12 months, 24 months
Effectiveness
Changes in overall health at all follow-up time points assessed via SF-36
Time frame: 6 weeks, 3 months, 6 months, 12 months, 24 months
Effectiveness
Change in disability index assessed at all follow-up time points via DASH
Time frame: 6 weeks, 3 months, 6 months, 12 months, 24 months
Radiographic
Radiolucencies around radial stem and ulnar screws
Time frame: 6 weeks, 3 months, 6 months, 12 months, 24 months
Radiographic
Subsidence of radial component
Time frame: 6 weeks, 3 months, 6 months, 12 months, 24 months
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Orthopedic Associates of Southwest Ohio
Dayton, Ohio, United States
RECRUITINGLehigh Valley Health Network
Allentown, Pennsylvania, United States
RECRUITINGUniversity of Pennsylvania Perelman School of Medicine
Philadelphia, Pennsylvania, United States
WITHDRAWNMedical College of Wisconsin
Milwaukee, Wisconsin, United States
RECRUITINGRadiographic
Screw breakage
Time frame: 6 weeks, 3 months, 6 months, 12 months, 24 months
Radiographic
Ulnar variance
Time frame: 6 weeks, 3 months, 6 months, 12 months, 24 months
Health Economic
Use of other concomitant medications
Time frame: 6 weeks, 3 months, 6 months, 12 months, 24 months
Health Economic
Post-operative recovery time (return to daily activities/work)
Time frame: 6 weeks, 3 months, 6 months, 12 months, 24 months
Health Economic
Post-operative rehabilitation details
Time frame: 6 weeks, 3 months, 6 months, 12 months, 24 months