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

Rheumatoid Arthritis Clinical Trial

Official title:

A.L.P.S. Proximal Humerus Plating System Post-Market Clinical Follow-up Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03626038
• Other study ID #: CMG2017-59T
• Status: Recruiting
• Phase: N/A
• Start date: June 19, 2018
• Est. completion date: July 2024

Study information

• Verified date: December 2023
• Source: Zimmer Biomet
• Contact: Kim Blick, BSBM
• Phone: 352-233-0866
• Email: kim.blick[@]zimmerbiomet.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 135
• Est. completion date: July 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Humeral Fractures
• Osteoarthritis
• Post-Traumatic Arthritis
• Proximal Humeral Fracture
• Psoriatic Arthritis
• Rheumatoid Arthritis
• Shoulder Fractures

Intervention

Device:
• A.L.P.S. Proximal Humerus Plating System
Anatomically contoured, locking plates that can be customized intra-operatively, multidirectional screws allow for stable fixation for a wide variety of patients.

Locations

Country	Name	City	State
Canada	The Research Institute of McGill University Health Centre	Montréal	Quebec
United States	Foundation for Orthopaedic Research & Education	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Re-operation	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.	1 year
Secondary	Clinical efficacy of the device is assessed using the American Shoulder and Elbow Surgeon Patient Questionnaire	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.	2 years
Secondary	Shoulder range of motion measurement	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.	2 years
Secondary	Clinical performance of the device is assessed using x-ray capture	X-ray capture will be used to analyze fracture healing	2 years