Injection of Autologous Bone Marrow Aspirate in Patients With Degenerative Disc Disease.

NCT05146583 | Unknown

• 1 other identifier: NYP19-04020103
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Lumbar discectomy and injection of purified cellular bone marrow concentrate or lumbar discectomy only

Conditions

Lumbar Disc Disease

Keywords

Sciatica; Lumbar Disc Herniation; Discectomy

Outcome Measures

Primary Outcomes (1)

• Change in Numeric Rating for Back pain at 12 months

  0 to 10 NRS

  Baseline, 3 months, 6 months, 12 months after surgery

Secondary Outcomes (5)

• Change in Oswestry Disability Index at 12 months

  Baseline, 3 months, 6 months, 12 months after surgery

• Disc Height Index

  Baseline and 12 months or longer folllow-up after surgery

• Pfirrman grading

  Baseline and 12 months or longer folllow-up after surgery

• Change in NRS Leg pain

  Baseline, 3 months, 6 months, 12 months after surgery

• Complications

  Continrous monitoring during study during one year after surgery

Interventions

Autologous bone marrow aspirate injected intradiscal after microdiscectomy PROCEDURE

Harvested from SI-joint, 2-5ml BMA is injected in the discectomy defect.

Discectomy only PROCEDURE

Transflaval discectomy with or without the use of a microtube (according to surgeons' preference).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with symptomatic lumbar disc herniation and discogenic back pain who meet the inclusion criteria may be eligible for this procedure.

You may qualify if:

• Male or female patients ≥18 years of age
• Radiologically (MRI) confirmed diagnosis degenerative disc disease of the lumbar spine and/or lumbar disc herniation
• Unresponsive to conservative/non-operative treatment for \>3 months
• Psychosocial, mental and physical ability to understand and to adhere to this protocol, especially adhering to the visit schedule follow-ups, and observe treatment plan
• Signed and dated informed consent document prior to any study-related procedures indicating that the patient has been informed of all pertinent aspects of the trial study-related procedures

You may not qualify if:

• Pregnant or breastfeeding patients
• Active malignancy
• Active chronic or acute infection
• Autoimmune disorder that impacts the lumbar spine (Ankylosing spondylitis, lupus eg.)
• Acute Episode or major mental illness
• Major cognitive impairment causing to inability to understand informed consent

Sponsors & Collaborators

• New York Presbyterian Hospital: lead

Study Sites (1)

New York Presbytarian Hospital

New York, New York, 10021, United States

RECRUITING

MeSH Terms

Conditions

Intervertebral disc disease; Sciatica; Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical

Central Study Contacts

Roger Hartl, Prof.dr.

CONTACT

(212) 821-0850; ermabell@cornell.edu.com

Pravesh Gadjradj, MD

CONTACT

(212) 821-0850; psg4001@med.cornell.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: on behalf of PI: Prof.dr.R.Hartl, chief of spine surgery

Study Record Dates

• First Submitted: November 10, 2021
• First Posted: December 7, 2021
• Study Start: November 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2023
• Last Updated: December 21, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)