DIAM™ Spinal Stabilization System Long Term Follow up Clinical Plan

NCT05201573 | Unknown

• 1 other identifier: CP21001
• Study Type: observational
• Target: 175
• Locations: 0 countries
• Sites: N/A

Brief Summary

A hybrid prospective/retrospective, multicenter, single-arm, data collection study.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

• Evaluate the safety associated with the use of the investigational implant during long term follow up

  The DIAM device, specifically at long-term follow-up. A subject is considered to be a long-term success if they are free from serious device-related adverse events through final follow-up. Secondary surgical intervention for treatment failure (i.e. recurrence of pain or functional impairment) without other serious device-related adverse event is not considered to be a serious device-related adverse event for the purposes of the primary endpoint.

  5-10 years after implantation

Secondary Outcomes (4)

• Back Pain evaluation

  5-10 years after implantation

• Back Pain evaluation

  5-10 years after implantation

• Back Pain evaluation

  5-10 years after implantation

• Back Pain evaluation

  5-10 years after implantation

Study Arms (1)

Subjects historically treated with DIAM

Subjects randomized to the DIAM arm and treated with the DIAM™ Spinal Stabilization System in the IDE study OR randomized to the Control arm and crossed over to receive treatment with the DIAM™ Spinal Stabilization System in the IDE study

Other: Observational

Interventions

Observational OTHER

This is an observational study of long term follow up data for patients who previously received the DIAM implant

Subjects historically treated with DIAM

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Data will be collected from up to 8 sites that participated in the DIAM Pivotal Study. There is no randomization for this study. The goal is to collect long-term follow-up data on patients who participated in the DIAM™Spinal Stabilization System - Pivotal Study and were randomized to the DIAM arm or who were randomized to the control arm AND crossed over to receive DIAM treatment.

You may qualify if:

• Subject randomized to the DIAM arm and treated with the DIAM™Spinal Stabilization System in the IDE study OR randomized to the Control arm and crossed over to receive treatment with the DIAM™ Spinal Stabilization System in the IDE study.
• Willing and able to consent to study procedures

Sponsors & Collaborators

• Companion Spine, LLC: lead
• MCRA: collaborator

MeSH Terms

Conditions

Low Back Pain

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Central Study Contacts

Sherif S Elsherif

CONTACT

202.552.5893; ssamy@mcra.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2022
• First Posted: January 21, 2022
• Study Start: January 17, 2022
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: January 21, 2022

Record last verified: 2022-01