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NCT03626038 | RECRUITING | Osteoarthritis

Post Market Clinical Follow-up (PMCF) Study of the A.L.P.S. Proximal Humerus Plating System
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.

Condition or disease

Osteoarthritis

Rheumatoid Arthritis

Post-Traumatic Arthritis

Psoriatic Arthritis

Proximal Humeral Fracture

Intervention/treatment

A.L.P.S. Proximal Humerus Plating System

Phase

NA

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 135 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A.L.P.S. Proximal Humerus Plating System Post-Market Clinical Follow-up Study
Actual Study Start Date : 2018-06-19
Estimated Primary Completion Date : 2025-05
Estimated Study Completion Date : 2025-05

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * 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
Exclusion Criteria
  • * 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.
Post Market Clinical Follow-up (PMCF) Study of the A.L.P.S. Proximal Humerus Plating System

Location Details

NCT03626038

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

COMPLETED

United States, Florida

Foundation for Orthopaedic Research & Education

Tampa, Florida, United States, 33637

RECRUITING

Canada, Quebec

The Research Institute of McGill University Health Centre

Montréal, Quebec, Canada, H3G 1A4