Osteocel® Plus in eXtreme Lateral Interbody Fusion (XLIF®)

Back Pain Clinical Trial

Official title:

Osteocel® Plus in eXtreme Lateral Interbody Fusion (XLIF®): Evaluation of Radiographic and Patient Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00948532
• Other study ID #: NUVA.OC.0801
• Status: Completed
• Phase: N/A
• First received: July 16, 2009
• Last updated: April 17, 2015
• Start date: March 2009
• Est. completion date: October 2012

Study information

• Verified date: April 2015
• Source: NuVasive
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

This is a prospective, non-randomized multi-center study to compare the use of Osteocel® Plus in subjects who receive XLIF® (eXtreme Lateral Interbody Fusion) surgery at one or two levels. These subjects will present with degenerative conditions in the lumbar spine that are amenable to surgical treatment and will be screened prior to study enrollment. Subjects will receive Osteocel Plus during their XLIF operation. Subjects will be followed for 24-months following surgery to determine the number of study subjects that are solidly fused at or before 24 months postoperatively, and to determine the mean time to fusion. This data will be compared to published and/or retrospective data for autograft, synthetic ceramics and Bone Morphogenetic Protein (BMP).

Description:

Osteocel Plus is an allograft cellular bone matrix containing native mesenchymal stem cells (MSCs) which is intended to mimic the biologic performance of autograft without the morbidity associated with the autograft harvest. Mesenchymal stem cells, like those found in Osteocel Plus, are naturally occurring in the body and can differentiate into a variety of tissue types, depending on the local environment. Once implanted, MSCs can differentiate into osteoblasts, which produce new bone matrix. MSCs also naturally secrete bone-inducing growth factors that signal the patient's endogenous cells to migrate and participate in the bone formation process. Osteocel Plus is different from other orthobiologic products such as DBM and allograft cancellous bone because it contains living stem cells, which provide osteogenic potential. The cells include mesenchymal stem cells from an adult human donor; they are not from an embryonic source.

This study is being conducted to determine the percentage of patients with solid spinal fusions after being treated with Osteocel in an XLIF procedure. Due to the unique processing conditions, Osteocel Plus retains a high concentration of stem cells in conjunction with the allograft bone matrix, so it is hypothesized that the fusion rate with Osteocel Plus will be comparable to published data for autograft. The Osteocel product family has already been used in approximately 15,000 cases worldwide.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Persistent back and/or leg pain unresponsive to conservative treatment for at least six (6) months, unless clinically indicated earlier

2. Indicated for interbody fusion of one or two contiguous lumbar segments (L1 to L5)

3. Objective evidence of primary diagnosis must be confirmed by appropriate imaging studies

4. 18-80 years of age at the date of written informed consent

5. Able to undergo surgery based on physical exam, medical history and surgeon judgment

6. Expected to survive at least 2 years beyond surgery

7. Willing and able to return for post-treatment exams according to the follow-up called for in the protocol

8. Signed and dated Informed Consent Form

Exclusion Criteria:

1. Patient has a mental or physical condition that would limit the ability to comply with study requirements

2. Lumbar spine abnormality requiring treatment at more than two levels

3. Systemic or local infection; active or latent

4. Previous failed fusion at the operative level

5. Diseases that significantly inhibit bone healing (osteoporosis, metabolic bone disease, uncontrolled diabetes, dialysis dependent renal failure, symptomatic liver disease)

6. Undergoing chemotherapy or radiation treatment, or chronic use of steroids (defined as more than 6 weeks of steroid use within 12 months of surgery, other than episodic use or inhaled corticosteroids)

7. Pregnant, or plans to become pregnant during the study

8. Subject is a prisoner

9. Involvement in active litigation relating to the spine (worker's compensation claim is allowed if it is not contended)

10. A significant general illness (e.g., HIV, active metastatic cancer of any type) is present; subject is immunocompromised or is being treated with immunosuppressive agents

11. Participating in another clinical study that would confound study data

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Back Pain
• Degenerative Disc Disease
• Intervertebral Disc Degeneration

Intervention

Biological:
• biologic, Osteocel Plus
Osteocel® Plus

Locations

Country	Name	City	State
United States	Duke University Medical Center	Chapel Hill	North Carolina
United States	Columbia Orthopaedic Group, Boone Hospital Center	Columbia	Missouri
United States	Broward Spine Institute	Hollywood	Florida
United States	Indiana Center for Neurosurgery	Indianapolis	Indiana
United States	Spine Midwest, St. Mary's Health Center	Jefferson City	Missouri
United States	Shiley Center for Orthopaedic, Scripps Green Hospital	La Jolla	California
United States	Western Regional Center for Brain & Spine Surgery, Surgery Center of S. Nevada	Las Vegas	Nevada
United States	Buffalo Spine Surgery, Kenmore Mercy	Lockport	New York
United States	Pinnacle Orthopaedics, Wellstone Kennestone Hospital	Marietta	Georgia
United States	South Florida Spine Institute, Mount Sinai Medical Center	Miami Beach	Florida
United States	The Spine Center of DuPage Medical Group, Edward Hospital	Naperville	Illinois
United States	Southeastern Spine Center, Doctors Hospital of Sarasota	Sarasota	Florida
United States	USF, Tampa General Hospital	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
NuVasive

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of subjects with radiographically apparent fusion.		6-months, 12-months and 24-months	No
Secondary	The evaluation of angular displacement on flexion/extension films.		Post-op, 6-week, 3-month, 6-month, 12-month, 24-month	No
Secondary	The evaluation of bridging bone on CT.		6-month, 12-month	No
Secondary	Preservation of interbody height over time.		All post-operative follow-up visits: Post-op, 6-week, 3-month, 6-month, 12-month, 24-month	No
Secondary	The rate of complications attributable to the use of Osteocel Plus requiring intervention.		All study follow-up visits: Post-op, 6-week, 3-month, 6-month, 12-month, 24-month	No
Secondary	The change in subject self-reported pain ratings (VAS scores).		from baseline through post-operation follow-up (visits at post-op, 6-week, 3-month, 6-month, 12-month and 24-months)	No
Secondary	The change in Oswestry Disability Index scores.		from baseline through post-operation follow-up (visits at post-op, 6-week, 3-month, 6-month, 12-month and 24-months)	No

External Links

•   NuVasive, Inc.