Pivotal Study of rhBMP-2/ACS/LT-CAGE® Device for Anterior Lumbar Interbody Fusion in Patients With Symptomatic Degenerative Disc Disease

A Clinical Investigation of Recombinant Human Bone Morphogenetic Protein-2 and Absorbable Collagen Sponge With the LT-CAGE® Device for Anterior Lumbar Interbody Fusion in Patients With Symptomatic Degenerative Disc Disease

This study is designed to assess the safety and effectiveness of the rhBMP-2/ACS/LT-CAGE® device as compared to the LT-CAGE® device with autogenous bone in patients with symptomatic degenerative disc disease using an open surgical technique.

Study Overview

• Status: Completed
• Conditions: Degenerative Disc Disease
• Intervention / Treatment: Device: rhBMP-2/ACS/LT-CAGE® Device; Device: Autogenous Bone/LT-CAGE® Device

• Study Type: Interventional
• Enrollment (Actual): 279
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Has degenerative disc disease as noted by back pain of discogenic origin, with or without leg pain, with degeneration of the disc confirmed by patient history ( e.g.,pain [leg, back, or symptoms in the sciatic nerve distribution], function deficit and/or neurological deficit) and radiographic studies ( e.g., CT, MRl, X-Ray, etc.) to include one or more of the following:

   • instability (defined as angular motion > 5° and/or translation >= 4mm, based on Flex/Ext radiographs);
   • osteophyte formation;
   • decreased disc height;
   • thickening of ligamentous tissue;
   • disc degeneration or herniation; and/or
   • facet joint degeneration.
2. Has preoperative Oswestry score > 35.
3. Has no greater than Grade 1 spondylolisthesis utilizing Meyerding's Classification (Meyerding HW, 1932.).
4. Has single-level symptomatic degenerative involvement from L4 to S1.
5. Is at least 18 years of age, inclusive, at the time of surgery.
6. Has not responded to non-operative treatment (e.g., bed rest, physical therapy, medications, spinal injections, manipulation, and/or TENS) for a period of at least 6 months.
7. If female of child-bearing potential, who is not pregnant or nursing, and who agrees to use adequate contraception for 16 weeks following surgery.
8. Is willing and able to comply with the study plan and sign the Patient Informed Consent Form.

Exclusion Criteria:

1. Had previous anterior spinal fusion surgical procedure at the involved level.
2. Has posterior spinal instrumentation (which will not be removed) stabilizing the involved level or has had a previous posterior lumbar interbody fusion procedure at the involved level.
3. Has a condition which requires postoperative medications that interfere with fusion, such as steroids.
4. Has been previously diagnosed with osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated.
5. Has presence of active malignancy.
6. Has overt or active bacterial infection, either local or systemic.
7. ls grossly obese, i.e., weight > 40% over ideal for their age and height.
8. Has fever ( temperature > 101° F oral) at the time of surgery.
9. Has a documented titanium alloy allergy or intolerance.
10. Is mentally incompetent. if questionable, obtain psychiatric consult.
11. Has a Waddell Signs of Inorganic Behavior score of 3 or greater.
12. Is a prisoner.
13. Is an alcohol and/or drug abuser as defined by currently undergoing treatment for alcohol and/or drug usage.
14. Is a tobacco user at the time of surgery.
15. Has received drugs which may interfere with bone metabolism within two weeks prior to the planned date of spinal fusion surgery (e.g., steroids or methotrexate).
16. Has a history of autoimmune disease (Systemic Lupus Erythematosus or Dermatomyositis).
17. Has a history of exposure to injectable collagen implants.
18. Has a history of hypersensitivity to protein pharmaceuticals (monoclonal antibodies or gamma globulins) or collagen.
19. Has received treatment with an investigational therapy within 28 days prior to implantation surgery or such treatment is planned during the 16 weeks following rhBMP-2/ACS implantation.
20. Has received any previous exposure to any/all BMP's of either human or animal extraction.
21. Has a history of allergy to bovine products or a history of anaphylaxis.
22. Has history of endocrine or metabolic disorder known to affect osteogenesis (e.g., Paget's disease, renal osteodystrophy, Ehlers- Danlos syndrome, or osteogenesis imperfecta).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: rhBMP-2/ACS	Device: rhBMP-2/ACS/LT-CAGE® Device; LT-CAGE® device with recombinant human bone morphogenetic protein-2 ( rhBMP-2) and the absorbable collagen sponge (ACS).; Other Names: Recombinant human bone morphogenetic protein
Active Comparator: Autogenous Bone	Device: Autogenous Bone/LT-CAGE® Device; LT-CAGE® device with autogenous bone taken from the iliac crest.; Other Names: Autograft

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall success	A patient will be considered an overall success if all of the following conditions are met: fusion;; pain/disability (Oswestry) improvement;; maintenance or improvement in neurological status;; no serious adverse event classified as implant associated or implant/surgical procedure associated;; no additional surgical procedure classified as a "failure."	24 months

Secondary Outcome Measures

Outcome Measure	Time Frame
General Health Status (SF-36)	24 months
Patient Satisfaction	24 months
Patient Global Perceived Effect	24 months
Disc Height Measurement	24 months
Pain Status (Numerical Rating Scale)	24 months

Collaborators and Investigators

• Sponsor: Medtronic Spinal and Biologics

Study record dates

Study Major Dates

• Study Start: August 1, 1998
• Primary Completion (Actual): October 1, 2002
• Study Completion (Actual): October 1, 2002

Study Registration Dates

• First Submitted: December 12, 2011
• First Submitted That Met QC Criteria: December 13, 2011
• First Posted (Estimate): December 14, 2011

Study Record Updates

• Last Update Posted (Actual): May 17, 2023
• Last Update Submitted That Met QC Criteria: May 16, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: symptomatic degenerative disc disease
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Intervertebral Disc Degeneration; Spinal Diseases
• Other Study ID Numbers: C-9702