Clinical trial NCT04921865: Case Series on the Clinical Performance of VA Clavicle and Clavicle Hook Plate 2.7 Systems
Official title: Observational Case Series on the Clinical Performance of the DePuy Synthes Variable Angle Clavicle Plate and Clavicle Hook Plate 2.7 Systems
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Clavicle
Acromioclavicular Joint
Fracture
Lead sponsor: AO Innovation Translation Center
Sponsor class: OTHER
First posted: 2021-06-10
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety aspects
timeFrame: 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
measure: Clinical performance
timeFrame: Through study completion, an average of 1 year
measure: Utility in terms of surgeons' experience
timeFrame: Assessed immediately after the surgery
measure: Surgical time
timeFrame: Assessed immediately after surgeries
measure: Fluoroscopy time
timeFrame: Assessed immediately after surgeries
measure: The Disabilities of the Arm Shoulder and Hand short form (QuickDASH)
timeFrame: 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
measure: Patient-Reported Outcomes Measurement Information System (PROMIS)
timeFrame: 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
Secondary outcomes:
Other outcomes:
measure: Patient characteristics
timeFrame: Baseline
measure: Patient characteristics
timeFrame: Baseline
measure: Patient characteristics
timeFrame: Baseline
measure: Patient characteristics
timeFrame: Baseline
measure: Comorbidities
timeFrame: Baseline
measure: Injury details
timeFrame: Baseline
measure: Injury details
timeFrame: Baseline
measure: Fracture classification
timeFrame: Baseline
measure: Surgical details
timeFrame: Intraoperative
measure: Surgical time
timeFrame: Intraoperative
measure: Plate details
timeFrame: Intraoperative
measure: Screw details
timeFrame: Intraoperative
measure: Adjunctive fixations
timeFrame: Intraoperative
measure: Patient reported outcomes
timeFrame: 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
measure: Radiographical outcomes - Screw density and distribution
timeFrame: Patients treated with clavicle plate: Intraoperative, 2 weeks; Patients treated with clavicle hook plate: Intraoperative, 2 weeks
measure: Radiographical outcomes - Osteolysis
timeFrame: Patients treated with clavicle hook plate: Intraoperative until device removal (approximately 3months)
measure: Radiographical outcomes - Bone union
timeFrame: 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
measure: Radiographical outcomes - Quality of reduction
timeFrame: Patients treated with clavicle plate: Immediately after surgery; Patients treated with clavicle hook plate: Immediately after surgery
measure: Radiographical outcomes - Acromioclavicular and coracoclavicular
timeFrame: 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
Locations:
city: Winston-Salem
country: United States
facility: Atrium Health Wake Forest Baptist
state: North Carolina
city: Cleveland
country: United States
facility: University Hospital
state: Ohio
city: Cleveland
country: United States
facility: Metrohealth Medical Center
state: Ohio
city: Columbia
country: United States
facility: Prisma Health Richland Hospital
state: South Carolina
city: Wien
country: Austria
facility: Klinik Ottakring
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
city: Münster
country: Germany
facility: Universitätsklinikum Münster
city: Luzern
country: Switzerland
facility: Luzerner Kantonsspital
Study officials:
affiliation: University College London Hospital
name: Simon Lambert
role: PRINCIPAL_INVESTIGATOR
References: