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

Sponsor

Zimmer Biomet (Industry)

Overall Status

Recruiting

CT.gov ID

NCT03626038

Collaborator

(none)

135

Enrollment

Locations

Arm

53.4

Anticipated Duration (Months)

67.5

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
Osteoarthritis Rheumatoid Arthritis Post-Traumatic Arthritis Psoriatic Arthritis Proximal Humeral Fracture	Device: A.L.P.S. Proximal Humerus Plating System	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

135 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 19, 2018

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patients who receive the A.L.P.S. Prox. Humerus Plating Sys. 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.	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.

Arm

Intervention/Treatment

Experimental: Patients who receive the A.L.P.S. Prox. Humerus Plating Sys.

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.

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.

Outcome Measures

Primary Outcome Measures

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

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.
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.
Clinical performance of the device is assessed using x-ray capture [2 years]
X-ray capture will be used to analyze fracture healing

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Foundation for Orthopaedic Research & Education	Tampa	Florida	United States	33637
2	The Research Institute of McGill University Health Centre	Montréal	Quebec	Canada	H3G 1A4