Clinical trial NCT03626038: Post Market Clinical Follow-up (PMCF) Study of the A.L.P.S. Proximal Humerus Plating System
Official title: A.L.P.S. Proximal Humerus Plating System Post-Market Clinical Follow-up Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Osteoarthritis
Rheumatoid Arthritis
Post-Traumatic Arthritis
Psoriatic Arthritis
Proximal Humeral Fracture
Keywords: Trauma
Medical Device
Performance
Safety
Proximal Humeral Fracture
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2018-08-10
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Re-operation
timeFrame: 1 year
Secondary outcomes:
measure: Clinical efficacy of the device is assessed using the American Shoulder and Elbow Surgeon Patient Questionnaire
timeFrame: 2 years
measure: Shoulder range of motion measurement
timeFrame: 2 years
measure: Clinical performance of the device is assessed using x-ray capture
timeFrame: 2 years
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Foundation for Orthopaedic Research & Education
state: Florida
city: Wahroonga
country: Australia
facility: Sydney Adventist Hospital
state: New South Wales
city: Montréal
country: Canada
facility: The Research Institute of McGill University Health Centre
state: Quebec
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Hallym University Kangnam Sacred Hearth Hospital
city: Seoul
country: Korea, Republic of
facility: Inje University Seoul Paik Hospital
city: Granges-Paccot
country: Switzerland
facility: Bone and Motion Training and Research Foundation
Study officials:
References: