A Focused Registry to Document the Use of the Short- or L... | NCT02093364

Studies
A Focused Registry to Document the Use of the Short- or Long-stemmed Radial Head Prosthesis (RHP)

NCT02093364

Sponsor

AO Clinical Investigation and Publishing Documentation

Status

Withdrawn

Last Update Posted

Aug 12, 2020Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Fracture of the Radial Head Which is Not Amendable to an Adequate Osteosynthesis
Post-traumatic Deformity or Arthroses
Failed Open Reduction Internal Fixation (ORIF) of a Radial Head Fracture
Failed Conservative Radial Head Fracture Treatment

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Aug 2020

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No participants enrolled

Expanded Access Info

Start Date

Jul 2015

Primary Completion Date

Dec 2015Estimated

Completion Date

Jan 2016Actual

First Submitted Date

Mar 18, 2014

First Submission Date that Met QC Criteria

Mar 19, 2014

First Posted Date

Mar 21, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 11, 2020

Last Update Posted Date

Aug 12, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this focused registry is to evaluate the clinical implications of the RHP position (relative to the articulations) regarding functional and radiographic parameters in patients treated with the RHP with a straight and curved stem.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

12 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluation of the functional outcome	Elaborate if there is an association between the implant head and stem position (relative to the elbow articulations), functional outcomes and radiological parameters (radiolucency and arthritis) after 1 year in patients treated with a RHP	12 Months

Secondary Outcomes

Measure	Description	Time Frame
Evaluation of functional outcome	Elaborate if there is an association between the implant head and stem position (relative to the elbow articulations), functional outcomes and radiological parameters (radiolucency and arthritis) after 2 years	24 months
Range of motion

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18 years or older
Use of a short-or long-stemmed DePuy Synthes Radial Head Prosthesis due to any of the following indications:
- Fresh fracture of the radial head which is not amendable to an adequate -steosynthesis
- Post-traumatic deformity or arthroses
- Failed open reduction internal fixation (ORIF)
- Failed conservative radial head fracture treatment
Informed consent obtained, i.e.:
- Ability to understand the content of the patient information / Informed Consent Form
- Willingness and ability to participate in the clinical investigation according to the Clinical Investigation Plan (CIP)
- Signed and dated Ethics Committee (EC) / Institutional Review Board (IRB) approved written informed consent

Exclusion Criteria:

Active infection at the affected elbow
Any not medically managed severe systemic disease
Pregnancy
Prisoner
Recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reliable assessment

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Primary care centers

Sampling Method

Non-Probability Sample

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases