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MDR ExploR Radial Head System PMCF

NCT ID: NCT05583448

Last Updated: 2024-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

93 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-16

Study Completion Date

2035-07-19

Brief Summary

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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

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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.

Conditions

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Elbow Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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ExploR Radial Head

Subjects who have received the ExploR Radial Head Device.

ExploR Radial Head

Intervention Type DEVICE

Patient must have undergone primary elbow arthroplasty with the ExploR Radial Head System according to a cleared indication.

Interventions

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ExploR Radial Head

Patient must have undergone primary elbow arthroplasty with the ExploR Radial Head System according to a cleared indication.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zimmer Biomet

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Norton Healthcare

Louisville, Kentucky, United States

Site Status

Akershus University Hospital

Lørenskog, , Norway

Site Status

Countries

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United States Norway

Other Identifiers

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MDRG2017-89MS-77E

Identifier Type: -

Identifier Source: org_study_id