MDR ExploR Radial Head System PMCF

Elbow Injury Clinical Trial

Official title:

Post-market Clinical Follow-up Study of the ExploR™ Radial Head System (Implants and Instrumentation) - A Retrospective Enrollment/Prospective Follow-Up Consecutive Series Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05583448
• Other study ID #: MDRG2017-89MS-77E
• Status: Enrolling by invitation
• Start date: August 16, 2022
• Est. completion date: July 19, 2035

Study information

• Verified date: May 2024
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 93
• Est. completion date: July 19, 2035
• Est. primary completion date: August 16, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Elbow Injuries
• Elbow Injury

Intervention

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

Locations

Country	Name	City	State
Norway	Akershus University Hospital	Lørenskog
United States	Norton Healthcare	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Countries where clinical trial is conducted

United States,  Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Device Safety	Assessed by recording frequency of adverse events during the length of the study.	10 years
Secondary	QuickDASH	QuickDASH measures musculoskeletal pain and function of the arm. Higher scores indicate higher severity of disability.	1, 3, 5, 7, and 10 years