OsteoAdapt SP Spinal Fusion (OASIS)

Purpose of this Study

In this study, people are placed by chance into one of three groups. Each group uses different materials during spine surgery to help the bones heal and grow together. Two groups will use a material called OsteoAdapt SP with different amounts of a growth factor inside a small device placed between the bones. The third group will use standard bone materials taken from the patient or donated bone products. The study compares these groups to see which option helps the bones heal best after surgery.

Who Can Participate?

Eligibility

People can join this study if they are 18 to 80 years old and fully grown. They must be planning to have a planned spine surgery for lower back problems, such as pain caused by worn out discs. They must have had this pain for a while and tried treatments like physical therapy or medicine for at least six months without enough relief. People must be healthy enough for surgery, have a certain level of back or leg pain, and be able to come to follow up visits. People cannot join if they have had certain past spine surgeries in the same area, have weak bones such as severe osteoporosis, have infections, or use tobacco or certain medicines like steroids close to the time of surgery. They also cannot join if they have serious health problems, certain autoimmune diseases, active infections like HIV or hepatitis, or cancer within the past five years.

Age Range

18-80

Sex/Genders

Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No

What is Involved?

Description

The purpose of this study is to find out if a material called OsteoAdapt SP is safe and works well as a replacement for the usual bone graft used in certain spine surgeries. Researchers also want to learn which amount of OsteoAdapt SP works best so it can be studied in a larger study in the future.

Locations

Duke University Hospital

Visit Timing

Weekdays

Compensation

Yes

Spanish Materials Available

No

Study Details

Full Title

A Prospective, Blinded, Controlled, Dose-Randomized Clinical Investigation of OsteoAdapt SP in Single-level Lumbar Interbody Fusion (ALIF/LLIF and TLIF) For the Treatment of Symptomatic Degenerative Disease of The Lumbosacral Spine

Principal Investigator

Peter
Passias

Protocol Number

PRO00120131

NCT ID

NCT06154005

Phase

II

Enrollment Status

Pending Open to Enrollment