Ignite Creation Date:
2024-05-06 @ 4:15 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04921865
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2021-05-28
Brief Title:
Case Series on the Clinical Performance of VA Clavicle and Clavicle Hook Plate 27 Systems
Sponsor:
AO Innovation Translation Center
Organization:
AO Innovation Translation Center
Study Overview
Official Title:
Observational Case Series on the Clinical Performance of the DePuy Synthes Variable Angle Clavicle Plate and Clavicle Hook Plate 27 Systems
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 andor 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 27 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None