ClavicleNCT04921865
Case Series on the Clinical Performance of VA Clavicle and Clavicle Hook Plate 2.7 Systems
An observational study of Clavicle and Acromioclavicular Joint, run by AO Innovation Translation Center at 7 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clavicle, Acromioclavicular Joint, Fracture
- What is being tested?
- DPS VA-LCP® Clavicle Plate 2.7 System; DPS VA-LCP® Clavicle Hook Plate 2.7 System
- Type of treatment
- Medical device
- How many people
- 76 participants
- Where
- 7 sitesin 4 countries
- Study dates
- 10 Jul 2024to 30 Sep 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any patients treated with the DPS VA-LCP® Clavicle Plate 2.7 System or the DPS VA-LCP® Clavicle Hook Plate 2.7 System for clavicular fracture or dislocations of the acromioclavicular joint
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 4 countries
United States3 sites, 3 recruiting
- Recruiting
Prisma Health Richland Hospital
Columbia, South Carolina, 29203
Daniel Cunningham, MD, Daniel.cunningham2@prismahealth.org
- Recruiting
Corewell Health
Grand Rapids, Michigan, 49503
Todd Conlan, 330-265-3097, todd.conlan@corewellhealth.org
Todd Conlan
- Recruiting
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157
Eben Carroll, Prof Dr, ecaroll@wakehealth.edu
Germany2 sites, 2 recruiting
- Recruiting
Universitätsklinikum Freiburg
Freiburg im Breisgau, 79106
Martin Jäger, MD, martin.jaeger@uniklinik-freiburg.de
Johannes Bausch, Dr, johannes.bausch@uniklinik-freiburg.de
- Recruiting
Universitätsklinikum Münster
Münster, 48149
Julia Sußiek, Dr, julia.sussiek2@ukmuenster.de
Austria1 site, 1 recruiting
- Recruiting
Klinik Ottakring
Vienna, 1160
Franz Kralinger, Prof Dr, ordination@kralinger.at
Richard Arnhold, Dr, richardarnhold@gmail.com
Switzerland1 site, 1 recruiting
- Recruiting
Luzerner Kantonsspital
Lucerne, 6000
Frank Beeres, Dr, frank.beeres@luks.ch
About this study
Official title: Observational Case Series on the Clinical Performance of the DePuy Synthes Variable Angle Clavicle Plate and Clavicle Hook Plate 2.7 Systems
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.
Read the 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.
- Conditions
- Clavicle, Acromioclavicular Joint, Fracture
- Being tested
- DPS VA-LCP® Clavicle Plate 2.7 System; DPS VA-LCP® Clavicle Hook Plate 2.7 System
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DPS VA-LCP® Clavicle Plate 2.7 System; DPS VA-LCP® Clavicle Hook Plate 2.7 SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 . Receives: Device: DPS VA-LCP® Clavicle Plate 2.7 System; DPS VA-LCP® Clavicle Hook Plate 2.7 System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety aspects
Adverse events (AE) related or possibly related to the investigational device (ADE) or the procedure
Measured: 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
Clinical performance
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)
Measured: Through study completion, an average of 1 year
Utility in terms of surgeons' experience
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
Measured: Assessed immediately after the surgery
Surgical time
Surgical time in minutes
Measured: Assessed immediately after surgeries
Fluoroscopy time
Fluoroscopy time in minutes
Measured: Assessed immediately after surgeries
The Disabilities of the Arm Shoulder and Hand short form (QuickDASH)
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.
Measured: 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
Patient-Reported Outcomes Measurement Information System (PROMIS)
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start10 Jul 2024
- Primary completion31 Jan 2027 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ClavicleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AO Innovation Translation Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simon Lambert, Principal investigator, University College London Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04921865
- Sponsor's protocol ID
- VA Clavicle
- Status last verified
- Aug 2025
- First submitted
- 28 May 2021
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jaeger M, Sussiek J, Beeres F, Carroll E, Conlan T, Cunningham D, Arnhold R, Lambert S. Observational case series on the clinical performance of the Variable Angle Clavicle Plate and Clavicle Hook Plate 2.7 systems: a study protocol. Front Surg. 2026 Jan 8;12:1694295. doi: 10.3389/fsurg.2025.1694295. eCollection 2025.
PubMed 41583835
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Case Series on the Clinical Performance of the DePuy Synthes Variable Angle Clavicle Plate and Clavicle Hook Plate 2.7 Systems
- ClinicalTrials.gov ID
- NCT04921865
- Acronym / sponsor ID
- VA Clavicle
- Conditions
- Clavicle, Acromioclavicular Joint, Fracture
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- AO Innovation Translation CenterUniversity, hospital or other
- Study start
- 10 Jul 2024 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 10 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated with the DPS VA-LCP® Clavicle Plate 2.7 System or Hook Plate 2.7 System | – | Device: DPS VA-LCP® Clavicle Plate 2.7 System; DPS VA-LCP® Clavicle Hook Plate 2.7 SystemAny 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 . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any patients treated with the DPS VA-LCP® Clavicle Plate 2.7 System or the DPS VA-LCP® Clavicle Hook Plate 2.7 System for clavicular fracture or dislocations of the acromioclavicular joint
Key inclusion criteria (7 listed)
- 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:
- Expected ability to attend postoperative FU visits
- Patient informed and consent obtained according to the IRB/EC defined and approved procedures
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DPS VA-LCP® Clavicle Plate 2.7 System; DPS VA-LCP® Clavicle Hook Plate 2.7 SystemThe 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. | Device | Patients treated with the DPS VA-LCP® Clavicle Plate 2.7 System or Hook Plate 2.7 System |
Primary outcome
Safety aspects
Time frame: 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
Clinical performance
Time frame: 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)
Utility in terms of surgeons' experience
Time frame: 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
Surgical time
Time frame: Assessed immediately after surgeries
Surgical time in minutes
Fluoroscopy time
Time frame: Assessed immediately after surgeries
Fluoroscopy time in minutes
The Disabilities of the Arm Shoulder and Hand short form (QuickDASH)
Time frame: 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.
Patient-Reported Outcomes Measurement Information System (PROMIS)
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Derived from this study: PubMed 41583835Jaeger M, Sussiek J, Beeres F, Carroll E, Conlan T, Cunningham D, Arnhold R, Lambert S. Observational case series on the clinical performance of the Variable Angle Clavicle Plate and Clavicle Hook Plate 2.7 systems: a study protocol. Front Surg. 2026 Jan 8;12:1694295. doi: 10.3389/fsurg.2025.1694295. eCollection 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Simon Lambert principal investigator
University College London Hospitals
7 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clavicle and Acromioclavicular Joint, run by AO Innovation Translation Center at 7 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Germany, Austria, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marco Minoia, PhD (+41 79 612 09 67, marco.minoia@aofoundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety aspects (time frame: 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 study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04921865, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2025.