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

Fracture Clinical Trial

Official title:

Observational Case Series on the Clinical Performance of the DePuy Synthes Variable Angle Clavicle Plate and Clavicle Hook Plate 2.7 Systems

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04921865
• Other study ID #: VA Clavicle
• Status: Not yet recruiting
• Start date: April 30, 2024
• Est. completion date: September 30, 2029

Study information

• Verified date: March 2024
• Source: AO Innovation Translation Center
• Contact: Alix Frischknecht
• Phone: +41 79 606 41 48
• Email: alix.frischknecht[@]aofoundation.org
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 76
• Est. completion date: September 30, 2029
• Est. primary completion date: January 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acromioclavicular Joint
• Clavicle
• Fracture

Intervention

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.

Locations

Country	Name	City	State
Germany	Universitätsklinikum Freiburg	Freiburg
United Kingdom	University College London Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
AO Innovation Translation Center

Countries where clinical trial is conducted

Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient characteristics	Demographics	Baseline
Other	Patient characteristics	Height in centimeters	Baseline
Other	Patient characteristics	Weight in kilograms	Baseline
Other	Patient characteristics	Body Mass Index (BMI) in kg/m^2	Baseline
Other	Comorbidities	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.	Baseline
Other	Injury details	Date of injury. Only the year of birth will be assessed.	Baseline
Other	Injury details	Side injured (i.e. left/right)	Baseline
Other	Fracture classification	- Clavicle fracture will be recorded using two classifications: AO/OTA Classification and Robinson Classification; - AC joint dislocation: Rockwood classification	Baseline
Other	Surgical details	Date of surgery	Intraoperative
Other	Surgical time	Surgical time (i.e. defined as skin-to-skin time) in minutes	Intraoperative
Other	Plate details	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	Intraoperative
Other	Screw details	Screw details will be documented per fragment side (medial and lateral) as: Number of screws; Diameter; Type; variable angle locking; metaphyseal; cortex	Intraoperative
Other	Adjunctive fixations	Osseo cerclage suture; Direct ligament suture; Internal brace; Ligament augmentation for primary repair; Suture anchors; Muscular reattachment; Other	Intraoperative
Other	Patient reported outcomes	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.	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
Other	Radiographical outcomes - Screw density and distribution	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	Patients treated with clavicle plate: Intraoperative, 2 weeks; Patients treated with clavicle hook plate: Intraoperative, 2 weeks
Other	Radiographical outcomes - Osteolysis	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	Patients treated with clavicle hook plate: Intraoperative until device removal (approximately 3months)
Other	Radiographical outcomes - Bone union	Bone union is defined as the presence of bridging callus in three of four cortices on orthogonal views	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
Other	Radiographical outcomes - Quality of reduction	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	Patients treated with clavicle plate: Immediately after surgery; Patients treated with clavicle hook plate: Immediately after surgery
Other	Radiographical outcomes - Acromioclavicular and coracoclavicular	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.	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
Primary	Safety aspects	Adverse events (AE) related or possibly related to the investigational device (ADE) or the procedure	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
Primary	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)	Through study completion, an average of 1 year
Primary	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	Assessed immediately after the surgery
Primary	Surgical time	Surgical time in minutes	Assessed immediately after surgeries
Primary	Fluoroscopy time	Fluoroscopy time in minutes	Assessed immediately after surgeries
Primary	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.	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
Primary	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.	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