Post Market Clinical Follow-up (PMCF) Study of the A.L.P.S. Proximal Humerus Plating System
- Conditions
- Psoriatic ArthritisRheumatoid ArthritisPost-Traumatic ArthritisProximal Humeral FractureOsteoarthritis
- Interventions
- Device: A.L.P.S. Proximal Humerus Plating System
- Registration Number
- NCT03626038
- Lead Sponsor
- Zimmer Biomet
- Brief Summary
This study is a multicenter, prospective, non-randomized, non-controlled post-market clinical follow-up study. The primary objective of this study is to confirm the safety and performance of the A.L.P.S. Proximal Humerus Plating System applied in proximal humerus fracture treatment.
- Detailed Description
The A.L.P.S. Proximal Humerus Plating System was developed to provide another surgical option for proximal humerus fracture fixation. The aim of the A.L.P.S. Proximal Humerus Plating System is to provide increased fracture stability while simultaneously increasing range of motion and decreasing the likelihood of screw perforation.
A minimum of 7 and maximum of 10 sites globally will be involved in this study. This number of clinical sites will allow for a better generalization of study data as well as allow for consistency to be developed across multiple regions. 135 implants will be included into the study. Each site will be allowed to enroll 27 humeri. Enrollment is competitive. All potential study subjects will be required to participate in the Informed Consent process.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 135
- Patient must be 18 years of age or older.
- Patient must have a primary proximal humerus fracture (Orthopaedic Trauma Association/ American Orthopedic 11-A, B, C) requiring surgical intervention and be eligible for fixation by plate and screws.
- Patients with failed conservative treatment within 3 weeks since injury.
- Patient must be able and willing to complete the protocol required follow-up.
- Patient must have a signed Institutional Review Board/Ethics Committee approved informed consent.
- Patient must be in a good nutritional state
- Delay of surgery for more than 3 weeks.
- Tumor induced fractures
- Patient is a prisoner.
- Pregnancy/ breast feeding
- Patient is a current alcohol or drug abuser.
- Patient has a mental or neurologic condition that will not allow for proper informed consent and/or participation in follow-up program.
- Patient has an active infection.
- Patient conditions including limitations in blood supply, obesity, or insufficient quantity or quality of bone stock.
- Patient is sensitive to foreign body material.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Patients who receive the A.L.P.S. Prox. Humerus Plating Sys. A.L.P.S. Proximal Humerus Plating System Subjects in need of proximal humerus fracture fixation who met the inclusion/exclusion criteria and received the A.L.P.S. Proximal Humerus Plating System. Subjects can be enrolled prospectively or retrospectively as indicated in the protocol.
- Primary Outcome Measures
Name Time Method Re-operation 1 year Re--operation within the first year post-initial surgery due to screw perforation of the humeral head, secondary displacement or impingement to relieve pain and/or improve function.
- Secondary Outcome Measures
Name Time Method Clinical efficacy of the device is assessed using the American Shoulder and Elbow Surgeon Patient Questionnaire 2 years Pain, function and activities of daily living are measured. The American Shoulder and Elbow Surgeon (ASES) scale is 0 to 100. 100 is the highest score and indicates the greatest function while 0 is the lowest score.
Clinical performance of the device is assessed using x-ray capture 2 years X-ray capture will be used to analyze fracture healing
Shoulder range of motion measurement 2 years Shoulder range of motion is assessed in degrees of directional movement. This will be measured during a physical exam by the investigator. Values measured include active and passive range of motion.
Trial Locations
- Locations (7)
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Hallym University Kangnam Sacred Hearth Hospital
🇰🇷Seoul, Korea, Republic of
Sydney Adventist Hospital
🇦🇺Wahroonga, New South Wales, Australia
Inje University Seoul Paik Hospital
🇰🇷Seoul, Korea, Republic of
Bone and Motion Training and Research Foundation
🇨🇭Granges-Paccot, Switzerland
Foundation for Orthopaedic Research & Education
🇺🇸Tampa, Florida, United States
The Research Institute of McGill University Health Centre
🇨🇦Montréal, Quebec, Canada