DIAM™ Spinal Stabilization System Long Term Follow up Clinical Plan

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05201573

Enrollment

175

Registered

2022-01-21

Start date

2022-01-17

Completion date

2022-02-28

Last updated

2022-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain

Brief summary

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

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.

Interventions

OTHERObservational

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

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Evaluate the safety associated with the use of the investigational implant during long term follow up	5-10 years after implantation	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.

Secondary

Measure	Time frame	Description
Back Pain evaluation	5-10 years after implantation	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.

Contacts

Primary ContactSherif S Elsherif

ssamy@mcra.com202.552.5893

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026