NCT05327959

Brief Summary

A commercially available product clinical study which aims to confirm the safety, performance, and clinical benefits to the patient of the ALPS Clavicle Plating system for both the implant itself and the instrumentation used during surgery.

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
9mo left

Started May 2022

Longer than P75 for not_applicable

Geographic Reach
2 countries

5 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
May 2022Mar 2027

First Submitted

Initial submission to the registry

March 10, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 14, 2022

Completed
29 days until next milestone

Study Start

First participant enrolled

May 13, 2022

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

4.6 years

First QC Date

March 10, 2022

Last Update Submit

February 10, 2026

Conditions

Clavicle FractureClavicle Injury

Keywords

clavicle

Outcome Measures

Primary Outcomes (1)

  • Number of subjects with fracture healing

    Number of subjects with fracture healing will be assessed through 12 months follow-up. Radiologic fracture healing is defined as: Bridging callus or no visible fracture lines on AP and 15-45° cephalic oblique radiographs.

    12 months

Secondary Outcomes (4)

  • Frequency and Incidence of Adverse Events (Safety)

    12 months

  • Range of Motion - Total shoulder motion

    12 months

  • Clinical efficacy of the device is assessed using the American Shoulder and Elbow Surgeons (ASES) Shoulder Score at 12 months follow-up

    12 months

  • Euroqol Patient Quality of life measured at 12 months follow-up (EQ-5D-5L)

    12 months

Study Arms (1)

Treatment Group

EXPERIMENTAL

The population target is all subjects suffering clavicle fracture suitable for open reduction and internal fixation by the A.L.P.S. Clavicle Plating System in accordance with the IFU.

Device: Clavicle open reduction and internal fixation

Interventions

Clavicle open reduction and internal fixationDEVICE

Clavicle open reduction and internal fixation using the A.L.P.S. Clavicle Plating System

Treatment Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient must be 18 years of age or older.
  • Patient must have a clavicle fracture requiring surgical intervention and be eligible for fixation by locking plate and screws.
  • Unilateral or Bilateral fractures.
  • Patient must be capable of understanding the doctor's explanation, following doctor's instruction, is able to and willing to complete the protocol required follow-up.
  • Patient must have a signed IRB/EC approved informed consent.

You may not qualify if:

  • Active infection.
  • Patients presenting conditions including blood supply limitations, insufficient quantity or quality of bone.
  • Patients with mental or neurologic conditions who are unwilling or incapable of giving proper informed consent, following postoperative care instructions.
  • Foreign body sensitivity where material sensitivity is suspected, testing is to be completed prior to implantation of the device.
  • Patient is a current alcohol or drug abuser
  • Patient is a prisoner
  • Patient known to be pregnant or breast feeding
  • Likely problems with maintaining follow-up program (e.g. patient with no fixed address, long distance, plans to move during course of study)
  • Not expected to survive the duration of the follow-up program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location

University of Michigan - Michigan Medicine

Ann Arbor, Michigan, 48137, United States

Location

Slocum Research & Education Foundation

Eugene, Oregon, 97401, United States

Location

University of Texas San Antonio

San Antonio, Texas, 78229, United States

Location

General Foundation of the University of Valladolid

Valladolid, 47002, Spain

Location

MeSH Terms

Interventions

Fracture Fixation, Internal

Intervention Hierarchy (Ancestors)

Fracture FixationOrthopedic ProceduresTherapeuticsSurgical Procedures, Operative

Study Officials

  • Hillary Overholser

    Zimmer Biomet

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2022

First Posted

April 14, 2022

Study Start

May 13, 2022

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

March 1, 2027

Last Updated

February 13, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)US(4)