MDR ExploR Radial Head System PMCF | NCT05583448

Studies
MDR ExploR Radial Head System PMCF

NCT05583448

Sponsor

Zimmer Biomet

Status

Enrolling by invitation

Last Update Posted

Feb 4, 2026Actual

Enrollment

93Estimated

Phase

Not provided

Conditions

Elbow Injury

Interventions

ExploR Radial Head

Countries

United States
Norway

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

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 16, 2022Actual

Primary Completion Date

Aug 16, 2026Estimated

Completion Date

Jul 19, 2035Estimated

First Submitted Date

Oct 13, 2022

First Submission Date that Met QC Criteria

Oct 13, 2022

First Posted Date

Oct 17, 2022Actual

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

Feb 3, 2026

Last Update Posted Date

Feb 4, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The objective of this retrospective and prospective consecutive series PMCF study is to collect long-term data confirming safety, performance and clinical benefits of the ExploR Radial Head System (implants and instrumentation) when used for radial head arthroplasty.

Detailed Description

This is a global, multi-center, retrospective enrollment, prospective follow-up, consecutive series post-market clinical follow-up study. The intent of the study is that subjects who have already had the surgical implant will be retrospectively enrolled in the study and data will be collected for a minimum of 10 years post-operatively. Subjects treated with the device will be identified and invited to participate in the study. 93 subjects will be enrolled into the study.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

93Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ExploR Radial Head		Subjects who have received the ExploR Radial Head Device.	Device: ExploR Radial Head

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ExploR Radial Head	Device	Patient must have undergone primary elbow arthroplasty with the ExploR Radial Head System according to a cleared indication.	ExploR Radial Head

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Device Survivorship	Measured by recording and analyzing the incidence and frequency of revisions, complications and adverse events. Survivorship is calculated with Kaplan Meier.	10 years
Device Safety	Assessed by recording frequency of adverse events during the length of the study.	10 years

Secondary Outcomes

Measure	Description	Time Frame
QuickDASH	QuickDASH measures musculoskeletal pain and function of the arm. Higher scores indicate higher severity of disability.	1, 3, 5, 7, and 10 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient must have undergone primary elbow arthroplasty with the ExploR Radial Head System according to a cleared indication, which includes the following:

Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with:

Joint destruction and/or subluxation visible on x-ray Resistance to conservative treatment

Primary replacement after fracture of the radial head
Symptomatic sequelae after radial head resection Patient must be 18 years of age or older. Patient must be willing and able to follow directions.

Exclusion Criteria:

Infection
Sepsis
Osteomyelitis
Uncooperative patient or patient with neurological disorders who are incapable of following directions
Osteoporosis
Metabolic disorders which may impair bone formation
Osteomalacia
Distant foci of infections which may spread to implant site
Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
Patient is a prisoner.
Patient is a current alcohol or drug abuser.
Patient has a psychiatric illness or cognitive deficit that will not allow for proper informed consent
Patient is known to be pregnant or breastfeeding.
Patient is unwilling to sign informed consent.

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

The study population should be a consecutive series of subjects implanted with the ExploR Radial Head System. The aim is to include 93 radial head arthroplasty procedures in the study.

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Norton Healthcare		Louisville	Kentucky	40241	United States
Akershus University Hospital

ID	Term
D001134	Arm Injuries
D014947	Wounds and Injuries