A.L.P.S. Clavicle Plating System PMCF

Last updated: November 7, 2024
Sponsor: Zimmer Biomet
Overall Status: Active - Enrolling

Phase

N/A

Condition

N/A

Treatment

Clavicle open reduction and internal fixation

Clinical Study ID

NCT05327959
CMG2020-08T
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient must be 18 years of age or older.

  • Patient must have a clavicle fracture requiring surgical intervention and beeligible for fixation by locking plate and screws.

  • Unilateral or Bilateral fractures.

  • Patient must be capable of understanding the doctor's explanation, followingdoctor's instruction, is able to and willing to complete the protocol requiredfollow-up.

  • Patient must have a signed IRB/EC approved informed consent.

Exclusion

Exclusion Criteria:

  • Active infection.

  • Patients presenting conditions including blood supply limitations, insufficientquantity or quality of bone.

  • Patients with mental or neurologic conditions who are unwilling or incapable ofgiving proper informed consent, following postoperative care instructions.

  • Foreign body sensitivity where material sensitivity is suspected, testing is to becompleted 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 fixedaddress, long distance, plans to move during course of study)

  • Not expected to survive the duration of the follow-up program

Study Design

Total Participants: 98
Treatment Group(s): 1
Primary Treatment: Clavicle open reduction and internal fixation
Phase:
Study Start date:
May 13, 2022
Estimated Completion Date:
March 31, 2027

Study Description

The objectives of this observational, prospective study with optional retrospective enrollment are to confirm safety, performance and clinical benefits of the A.L.P.S Clavicle Plating System and its instrumentation by analysis of fracture healing, functional outcome and adverse events.

The safety of the system will be assessed by monitoring the frequency and incidence of adverse events including re-operations. Relation of the events to implant, instrumentation and/or procedure should be specified.

The performance will be evaluated by assessment of fracture/osteotomy healing and functional outcome of all enrolled study subjects.

Connect with a study center

  • General Foundation of the University of Valladolid

    Valladolid, 47002
    Spain

    Site Not Available

  • Cleveland Clinic Florida

    Weston, Florida 33331
    United States

    Site Not Available

  • University of Michigan - Michigan Medicine

    Ann Arbor, Michigan 48137
    United States

    Site Not Available

  • Slocum Research & Education Foundation

    Eugene, Oregon 97401
    United States

    Site Not Available

  • University of Texas San Antonio

    San Antonio, Texas 78229
    United States

    Site Not Available

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