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NCT Number: NCT05327959

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Clavicle Fracture Clavicle Injury

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

General Foundation of the University of Valladolid, Valladolid, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Clavicle open reduction and internal fixation

Device

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

Primary outcomes

  1. Number of subjects with fracture healing

    Time frame: 12 months

    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.

Secondary outcomes

  1. Frequency and Incidence of Adverse Events (Safety)

    Time frame: 12 months

    Monitoring the frequency and incidence of adverse events, serious adverse events, adverse device effects, serious adverse device effects, and unanticipated serious adverse device effects as well as device deficiencies.

  2. Range of Motion - Total shoulder motion

    Time frame: 12 months

    Range of Motion (affected and contralateral), Forward elevation (maximum arm-trunk angle), External rotation (arm comfortably at side), External rotation (arm at 90 degrees of abduction), Internal rotation (thumb to back) spinous process, Cross-body adduction (antecubital fossa to opposite acromion (cm)

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

    Time frame: 12 months

    The ASES scale is 0-100. 100 is the highest score and indicates the greatest function while 0 is the lowest score.

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

    Time frame: 12 months

    The EuroQol five dimensions questionnaire (EQ-5D-5L) is a five dimensional self-assessment that is comprised of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. These five dimensions can be used to index a subject's health utility on a scale of 0 to 1, where 0 is death and 1 is perfect health. The scoring rule for EQ-5D permits scores less than 0, implying that some health states may be worse than death.

Sponsors and collaborators

Lead sponsor

Zimmer Biomet

Industry

Registry information

Official study title

A.L.P.S. Clavicle Plating System for Clavicle Fracture Fixation Post-Market Follow-up Study (Implants and Instrumentation)

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Apr 14, 2022
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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