DIAM™ Spinal Stabilization System Long Term Follow up Clinical Plan

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

Study Overview

• Status: Not yet recruiting
• Conditions: Low Back Pain
• Intervention / Treatment: Other: Observational

Detailed Description

Collect long-term follow-up data with x-rays and CT on subjects who received the DIAM™ Spinal Stabilization System through the original IDE protocol.

Data collected at one-time point from subjects with at least 5 years of follow-up data.

• Study Type: Observational
• Enrollment (Anticipated): 175

Contacts and Locations

• Study Contact: Name: Sherif S Elsherif; Phone Number: 202.552.5893; Email: ssamy@mcra.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• NA

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; This is an observational study of long term follow up data for patients who previously received the DIAM implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Back Pain evaluation	Composite overall success consisting of: Pain/disability (Oswestry) success (≥15 pt. improvement relative to baseline) No serious adverse event is classified as "implant-associated", "procedure associated" or "implant-/surgical procedure associated." No additional surgical procedure at the involved level is classified as a failure.	5-10 years after implantation
Back Pain evaluation	Change in back pain score compared to baseline	5-10 years after implantation
Back Pain evaluation	Back pain success calculated as: Pre-treatment Score - Post-treatment Score > 0 (Score = pain intensity + pain frequency)	5-10 years after implantation
Back Pain evaluation	SF-36/RAND-36 success calculated by: PCSPost-tx - PCSPre-tx > 0	5-10 years after implantation

Collaborators and Investigators

• Sponsor: Companion Spine, LLC
• Collaborators: MCRA

Study record dates

Study Major Dates

• Study Start (Anticipated): January 17, 2022
• Primary Completion (Anticipated): February 28, 2022
• Study Completion (Anticipated): February 28, 2022

Study Registration Dates

• First Submitted: January 6, 2022
• First Submitted That Met QC Criteria: January 20, 2022
• First Posted (Actual): January 21, 2022

Study Record Updates

• Last Update Posted (Actual): January 21, 2022
• Last Update Submitted That Met QC Criteria: January 20, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: CP21001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes