A Multicenter Prospective Registry for the Management of Degenerative Spine Disorders

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

908 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-31

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Details regarding the degenerative spine disorders will be collected with a specific focus on the use of osteobiologics in treating degenerative conditions and their impact on fusion, as well as patient-reported outcomes for these conditions.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

SpineTRACK Registry - Spinal Outcomes Registry

NCT01372592

Vertebra; Degeneration Spinal Trauma Spinal Deformity

COMPLETED

OssDsign® Spine Registry Study ("Propel")

NCT05329129

Degenerative Disc Disease Spinal Stenosis

RECRUITING

Prospective Study of Minimally Invasive Spine Surgery

NCT01045473

Degenerative Disk Disease Spondylolisthesis Spinal Stenosis +1 more

UNKNOWN

Proprio Spine Measurement Tool

NCT07023393

Intervertebral Disc Degeneration Intervertebral Disc Displacement Spinal Curvatures +5 more

NOT_YET_RECRUITING NA

Bone Graft Materials Observational Registry

NCT00974623

Degenerative Disc Disease Herniated Disc Spinal Stenosis +5 more

TERMINATED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The registry is designed to be open-ended. However, a statistical evaluation of the content und structure of database and CRFs in order to investigate the feasibility and quality of data collection is planned to take place prior to the registry expansion.

Variables applicable to patients with a degenerative spine disorder which will be collected in the registry include:

* Patient details
* Symptoms
* Diagnosis
* Imaging assessment
* Treatment details

Feasibility phase:

The statistical evaluation of the feasibility and quality of data collection will be performed after the first 5 sites have each enrolled 12 patients with a degenerative pathology and documented one follow-up visit. During this evaluation, enrolment of further patients can be continued.

Based on the findings of this feasibility phase, adjustments to the existing database can be performed before the registry is rolled out on larger scale.

Registry expansion:

Following the evaluation process of the feasibility phase, the registry will be expanded to allow data entry in more sites globally. Multi-site participation of this registry will be rolled-out in stages, and will be offered to sites with appropriate expertise which are selected based on their potential (interest, resources and expected patient volume).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Degenerative Diseases, Spinal Cord

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patient aged 18 years or older
* Patient diagnosed with a degenerative spine disorder who receives treatment for the degenerative spine disorder
* Patient capable of understanding the content of the patient information / Informed Consent Form
* Patient willing and able to participate in the registry
* Patient who has agreed to participate in the registry by providing consent according to the applicable local law and the declaration of Helsinki