OssDsign® Spine Registry Study ("Propel")

Recruiting

• Conditions: Degenerative Disc Disease; Spinal Stenosis

• Registration Number: NCT05329129
• Lead Sponsor: OssDsign

Brief Summary

The purpose of this multi-center, prospective, observational registry is to gather information on the clinical outcomes and real-world use of commercially available bone graft substitutes manufactured by OssDsign® AB, in patients who require spine fusion.

Detailed Description

This multi-center study (up to 10 US study sites) is a post market, prospective, observational spine fusion registry. The outcomes of patients undergoing spine fusion with OssDsign® bone grafts will be documented and evaluated for the purposes of post market clinical follow up as part of OssDsign® post market surveillance activities. The length of study duration and number to be recruited is open-ended but initially a target of 300 subjects will be recruited and followed up for a period of 24 months ± 90 days after their index surgery in which an OssDsign® bone graft has been implanted.

Study Timeline

• Study First Submitted: 2022-03-22
• Study Start: 2022-03-23
• Study First Submitted QC: 2022-04-08
• Study First Posted: 2022-04-14
• Status Verified: 2024-05
• Last Update Submitted: 2025-04-08
• Last Update Posted: 2025-04-11
• Primary Completion: 2027-03-23
• Study Completion: 2027-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

• Patients not meeting all of the inclusion criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of bone fusion	12 months ± 60 days post-operative examination	Assessment of the rate of bone fusion via Computerized Tomography (CT)/x-ray based on evidence of continuous bone bridging from the superior to the inferior vertebral body at the target level.

Secondary Outcome Measures

Name	Time	Method
Neurological Function	Up to 4 months, 6, 12 and 24 months	All subjects will be assessed for sensory, reflex, and muscle strength (motor) by the clinician
Presence of bone fusion	6, 12 and 24 months	All subjects will undergo x-ray evaluation to include AP and neutral lateral views pre-operatively. At post-operative visits AP and neutral lateral x-rays, plus flexion and extension x-rays (if standard care) taken with the subject standing up and/or a CT scan taken.
Quality of Life Questionnaire: Oswestry Disability Index	Up to 4 months, 6, 12 and 24 months	A questionnaire used to measure a patient's permanent functional disability scored 0-4, (no disability) to 35-50, (completely disabled).
Quality of Life Questionnaire: Visual Analog Scale (VAS)	Up to 4 months, 6, 12 and 24 months	A self rated pain scale from 0 (no pain) to 10 (worst imaginable pain)
Quality of Life Questionnaire: Short Form 36 (SF-36)	Up to 4 months, 6, 12 and 24 months	A Questionnaire used to measure the impact of clinical and social interventions using eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability
Quality of Life Questionnaire: Neck Disability Index (NDI)	Up to 4 months, 6, 12 and 24 months	A self-reported questionnaire to determine how pain affects everyday life and assess the level of disability and scored from 0 (no disability) to 50 (complete disability).
Safety review of device related AE's	Throughout study, 24 months	Review of Adverse Events

Trial Locations

Locations (13)

Central Connecticut Neurosurgery and Spine; 🇺🇸 New Britian, Connecticut, United States

Orthopedic Associates of Hartford; 🇺🇸 Hartford, Connecticut, United States

Yale Center for Clinical Investigation, Yale School of Medicine; 🇺🇸 New Haven, Connecticut, United States

Minimally Invasive Spine Center of South Florida; 🇺🇸 Miami, Florida, United States

Foundation for Orthopaedic Research and Education; 🇺🇸 Tampa, Florida, United States

Community Health Partners Neuroscience; 🇺🇸 Fresno, California, United States

San Diego Neurosurgery; 🇺🇸 San Diego, California, United States

Northeast Georgia Medical Center; 🇺🇸 Gainesville, Georgia, United States

Orthopaedic Institute of Western Kentucky; 🇺🇸 Paducah, Kentucky, United States

OrthoBethesda Research Foundation; 🇺🇸 Bethesda, Maryland, United States

Carle Foundation Hospital, NeuroScience Institute; 🇺🇸 Urbana, Illinois, United States

Twin Cities Orthopedics; 🇺🇸 Edina, Minnesota, United States

University Orthopedics Center; 🇺🇸 State College, Pennsylvania, United States