Case Series on the Clinical Performance of VA Clavicle and Clavicle Hook Plate 2.7 Systems

Sponsor
AO Innovation Translation Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04921865
Collaborator
(none)
76
2
34
38
1.1

Study Details

Study Description

Brief Summary

The purpose of this study is to gather early and mid- to long-term evidence to confirm the clinical performance, safety and use of the Clavicle Plate and Clavicle Hook Plate System.

A minimum of 76 patients with clavicle fractures or dislocations of the AC joint surgically treated with any plate from the DPS VA-LCP Clavicle System will be enrolled in this observational post-market clinical investigation.

Outcomes will be collected until up to 2 years after surgery.

Condition or Disease Intervention/Treatment Phase
  • Device: DPS VA-LCP® Clavicle Plate 2.7 System; DPS VA-LCP® Clavicle Hook Plate 2.7 System

Detailed Description

Common problems with existing clavicular plates are poor plate 'fit,' unbalance fixation, plate prominence, associated soft tissue irritation, subacromial pain, plate and/or fixation failure (due to unbalanced fixation) and high reoperation rate (for plate removal) [1-3]. The newly developed DePuy Synthes (DPS) variable angle locking compression plate (VA-LCP®) Clavicle 2.7 System was designed to address these problems. The system consists of lateral, shaft and medial plates and hook plates of different sizes to cover a wide variation in clavicular morphology and diverse fracture, fracture-dislocation and dislocation indications.

The objective is to describe the short and long-term clinical performance and safety of both systems, as well as the functional outcomes of this patient population.

Outcomes will be collected at baseline, 2 weeks, 6 weeks, 3 months, 6 months 1, and 2 years after surgery. In addition, the surgeons' experience and utility of the devices will be surveyed. For the short term evaluation, an interim analysis will be done as soon as 30 patients in each group have completed 6 months of follow-up (FU). The final evaluation of long-term outcomes will be done after 2 years of FU.

All treatments and follow-up visits are according to standard of care.

Study Design

Study Type:
Observational
Anticipated Enrollment :
76 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Observational Case Series on the Clinical Performance of the DePuy Synthes Variable Angle Clavicle Plate and Clavicle Hook Plate 2.7 Systems
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Jan 31, 2026
Anticipated Study Completion Date :
Jul 31, 2026

Arms and Interventions

Arm Intervention/Treatment
Patients treated with the DPS VA-LCP® Clavicle Plate 2.7 System or Hook Plate 2.7 System

Any patient undergoing surgical treatment for the fixation of clavicle bone fragments and acromioclavicular joint dislocations using the DPS VA-LCP® Clavicle Plate 2.7 System or DPS VA-LCP® Clavicle Clavicle Hook Plate 2.7 .

Device: DPS VA-LCP® Clavicle Plate 2.7 System; DPS VA-LCP® Clavicle Hook Plate 2.7 System
The DPS VA-LCP® Clavicle Plate 2.7 System is indicated for the fixation of clavicle bone fragments. The system consists of three plate types: lateral, shaft, and medial, each available in different sizes and materials (titanium alloy and stainless steel). Each plate is available in left and right. The DPS VA-LCP® Clavicle Clavicle Hook Plate 2.7 System is indicated or the fixation of lateral clavicle fractures and AC joint dislocations. The Clavicle Hook Plate system consists of three plate types: long, short and button plates.

Outcome Measures

Primary Outcome Measures

  1. Safety aspects [Patients treated with clavicle plate: From baseline up to 24 months after surgery; Patients treated with clavicle hook plate: From baseline until device removal (approximately 3months) and up to 12 months after device removal]

    Adverse events (AE) related or possibly related to the investigational device (ADE) or the procedure

  2. Clinical performance [Through study completion, an average of 1 year]

    The outcome measures for clinical performance are a subcategory of safety-related parameters (e.g. incidence of complaints related to plate prominence or discomfort, fracture union rate, rate of stable AC joint healing)

  3. Utility in terms of surgeons' experience [Assessed immediately after the surgery]

    Surgeons satisfaction with the use and handling of the devices is evaluated in a questionnaire using 5-point Likert scale questions. These include: Surgical time (skin to skin) required for fracture reduction and fixation Much less time than with other implants Slightly less time than with other implants No difference with other implants More time than with other implants Much more time than with other implants Surgeon's impression of the fitting of the device Implant fitted well, no contouring required Implant fitted well, minimal contouring required Implant fitted well laterally but required contouring medially Implant fitted well medially but required contouring laterally Implant required contouring medially and laterally

  4. Surgical time [Assessed immediately after surgeries]

    Surgical time in minutes

  5. Fluoroscopy time [Assessed immediately after surgeries]

    Fluoroscopy time in minutes

  6. The Disabilities of the Arm Shoulder and Hand short form (QuickDASH) [Patients treated with clavicle plate: From baseline up to 24 months after surgery; Patients treated with clavicle hook plate: From baseline until device removal (approximately 3months) and up to 12 months after device removal]

    The Disabilities of the Arm Shoulder and Hand short form (QuickDASH) questionnaire was designed as an occupational health and disability questionnaire. It includes 30 questions that have to be rated from 1 ("no difficulty") to 5 ("unable") where lower values indicate less disability and higher values indicate more disability.

  7. Patient-Reported Outcomes Measurement Information System (PROMIS) [Patients treated with clavicle plate: From baseline up to 24 months after device implantation surgery; Patients treated with clavicle hook plate: From baseline until device removal surgery (approximately 3months) and up to 12 months after device removal]

    The PROMIS Physical Function Upper Extremity Short Form 7a v2.0 (2018) consists of 7 questions aimed to evaluate activities that require use of the upper extremity including shoulder, arm, and hand activities. Questions can be rated from 1 "without any difficulties" to 5 "unable to do" where lower values indicate less disability and higher values indicate more disability.

Other Outcome Measures

  1. Patient characteristics [Baseline]

    Demographics

  2. Patient characteristics [Baseline]

    Height in centimeters

  3. Patient characteristics [Baseline]

    Weight in kilograms

  4. Patient characteristics [Baseline]

    Body Mass Index (BMI) in kg/m^2

  5. Comorbidities [Baseline]

    Concomitant diseases will be assessed using the Charlson Comorbidity Index (CCI). This score assesses the comorbidity level by considering both the number and severity of pre-defined comorbid conditions. It provides a weighted score of a patient's comorbidities which can be used to predict mortality risk. The minimum possible score is 0 (no comorbidities) and maximum 29. The higher the score, the more likely the predicted outcome will result in mortality.

  6. Injury details [Baseline]

    Date of injury. Only the year of birth will be assessed.

  7. Injury details [Baseline]

    Side injured (i.e. left/right)

  8. Fracture classification [Baseline]

    - Clavicle fracture will be recorded using two classifications: AO/OTA Classification and Robinson Classification - AC joint dislocation: Rockwood classification

  9. Surgical details [Intraoperative]

    Date of surgery

  10. Surgical time [Intraoperative]

    Surgical time (i.e. defined as skin-to-skin time) in minutes

  11. Plate details [Intraoperative]

    Clavicle Plate System Type of plate and size Lateral CS1 CS2 CS3 Shaft CS1 CS2 CS3 XL Medial Material Stainless steel Titanium alloy Clavicle Hook System Type of plate and hook depth Long 9 mm 12 mm 15 mm Short 9 mm 12 mm 15 mm Button 9 mm 12 mm 15 mm Material Stainless steel Titanium alloy

  12. Screw details [Intraoperative]

    Screw details will be documented per fragment side (medial and lateral) as: Number of screws Diameter Type variable angle locking metaphyseal cortex

  13. Adjunctive fixations [Intraoperative]

    Osseo cerclage suture Direct ligament suture Internal brace Ligament augmentation for primary repair Suture anchors Muscular reattachment Other

  14. Patient reported outcomes [Patients treated with clavicle plate: From baseline up to 24 months after surgery; Patients treated with clavicle hook plate: From baseline until device removal (approximately 3months) and up to 12 months after device removal]

    Pain Numeric Rating Scale (NRS). Local pain will be assessed with the Numerical Rating Scale (NRS). The scale range goes from 0 (no pain) to 10 (worst imaginable pain). A higher value correlates with greater pain.

  15. Radiographical outcomes - Screw density and distribution [Patients treated with clavicle plate: Intraoperative, 2 weeks; Patients treated with clavicle hook plate: Intraoperative, 2 weeks]

    Will be assessed in intraoperative or the first postoperative image by analyzing the screw placement with regards to the fracture line, their distribution and type of screws used

  16. Radiographical outcomes - Osteolysis [Patients treated with clavicle hook plate: Intraoperative until device removal (approximately 3months)]

    Defined as the presence of a lucent line in the acromion around the tip and body hook of the clavicle hook plate. It will be documented as: Not assessable Partial: any lucency zone around the hook Tip: lucency limited to the tip of the hook Complete: lucency around all zones of the hook

  17. Radiographical outcomes - Bone union [Patients treated with clavicle plate: From baseline up to 24 months after surgery; Patients treated with clavicle hook plate: From baseline until device removal (approximately 3months) and up to 12 months after device removal]

    Bone union is defined as the presence of bridging callus in three of four cortices on orthogonal views

  18. Radiographical outcomes - Quality of reduction [Patients treated with clavicle plate: Immediately after surgery; Patients treated with clavicle hook plate: Immediately after surgery]

    In cases of fixation failure, quality of reduction will be assessed in the immediate postoperative radiographs and documented as: Accurate reduction of simple fracture Accurate alignment of complex fracture Inaccurate reduction of simple fracture Inaccurate alignment of complex fracture

  19. Radiographical outcomes - Acromioclavicular and coracoclavicular [Patients treated with clavicle plate: From baseline up to 24 months after surgery; Patients treated with clavicle hook plate: From baseline until device removal (approximately 3months) and up to 12 months after device removal]

    Acromioclavicular and coracoclavicular distances (in mm) will be assessed using AC joint anteroposterior and Alexander views (if available). The AC distance is the distance between the most medial point on the acromion visible on an anteroposterior view of the AC joint and a point on a line drawn perpendicular to the plane of the dorsal aspect of the lateral or fifth of the clavicle.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Age >= 18 years

  • Unilateral clavicel injury and primary surgical treatment within 21 days from injury with a DPS VA-LCP® Clavicle Plate according to manufacturer's instruction use:

  • VA-LCP® Clavicle Plates 2.7: Fixation of clavicle bone fragments

  • VA-LCP® Clavicle Hook Plates 2.7: Fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint

  • VA-LCP Clavicle Button Hook Plates 2.7: Fixation of acromioclavicular joint dislocations

  • Expected ability to attend postoperative FU visits

  • Patient informed and consent obtained according to the IRB/EC defined and approved procedures

Exclusion Criteria:
  • Stable clavicle fractures

  • Systemic infection or infection localized to the site of the proposed implantation

  • Concomitant nerve or vessel injury

  • Polytrauma (Injury Severity Score ≥ 16)

  • BMI ≥40

  • Uncontrolled severe systemic disease or terminal illness

  • Intraoperative decision to use other implant

Contacts and Locations

Locations

Site City State Country Postal Code
1 Universitätsklinikum Freiburg Freiburg Germany 79106
2 University College London Hospital London United Kingdom NW1 2BU

Sponsors and Collaborators

  • AO Innovation Translation Center

Investigators

  • Principal Investigator: Simon Lambert, University College London Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
AO Innovation Translation Center
ClinicalTrials.gov Identifier:
NCT04921865
Other Study ID Numbers:
  • VA Clavicle
First Posted:
Jun 10, 2021
Last Update Posted:
Jul 20, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jul 20, 2022