Pilot Study of rhBMP/BCP With or Without the TSRH® Spinal System for Posterolateral Lumbar Fusion in Patients With Degenerative Disc Disease

NCT ID: NCT01494441

Last Updated: 2023-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-05-31
• Study Completion Date: 2003-03-31

Brief Summary

The purpose of this pilot clinical trial is to evaluate both device designs (rhBMP-2/BCP and rhBMP-2/BCP/TSRH® spinal System) as methods of facilitating spinal fusion as compared to instrumented fusion with autograft in patients with symptomatic degenerative disc disease.

Conditions

Degenerative Disc Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

rhBMP-2/BCP

Group Type: EXPERIMENTAL

rhBMP-2/BCP

Intervention Type: PROCEDURE

The rhBMP-2/BCP device component consists of recombinant human Bone Morphogenetic Protein-2 ( rhBMP-2) and the biphasic calcium phosphate (BCP) carrier.

rhBMP-2/BCP/TSRH® Spinal System

Group Type: EXPERIMENTAL

rhBMP-2/BCP/TSRH® Spinal System

Intervention Type: DEVICE

rhBMP-2/BCP device will be used in conjunction with the posterior spinal fixation system, the TSRH® Spinal System.

Autograft/TSRH® Spinal System

Group Type: ACTIVE_COMPARATOR

Autograft/TSRH® Spinal System

Intervention Type: DEVICE

The control device will be autogenous bone from the iliac crest of the patient used in conjunction with the TSRH® spinal System.

Interventions

rhBMP-2/BCP

The rhBMP-2/BCP device component consists of recombinant human Bone Morphogenetic Protein-2 ( rhBMP-2) and the biphasic calcium phosphate (BCP) carrier.

Intervention Type: PROCEDURE

rhBMP-2/BCP/TSRH® Spinal System

rhBMP-2/BCP device will be used in conjunction with the posterior spinal fixation system, the TSRH® Spinal System.

Intervention Type: DEVICE

Autograft/TSRH® Spinal System

The control device will be autogenous bone from the iliac crest of the patient used in conjunction with the TSRH® spinal System.

Intervention Type: DEVICE

Other Intervention Names

recombinant human Bone Morphogenetic Protein-2; biphasic calcium phosphate; recombinant human Bone Morphogenetic Protein-2; biphasic calcium phosphate; Autograft

Eligibility Criteria

Inclusion Criteria

1. Has degenerative disc diseases 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 > 4 mm, 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 > 30.

3. Has no greater than Grade 1 spondylolisthesis utilizing Meyerding's Classification (Meyerding HW,1932.).

4. Requires fusion of a single level disc space from L1 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. Has primary diagnosis of a spinal disorder other than degenerative disc disease with Grade1 or less spondylolisthesis at the involved level.

2. Had previous spinal fusion surgical procedure at the involved level.

3. Require spinal fusion at more than one lumbar level.

4. Has a condition which requires postoperative medications that interfere with fusion, such as steroids.

5. Has been previously diagnosed with osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated.

6. Has presence of active malignancy.

7. Has overt or active bacterial infection, either local or systemic.

8. Is grossly obese, i.e., weight > 40% over ideal for their age and height.

9. Has fever ( temperature >101°F oral) at the time of surgery.

10. Has a documented titanium alloy allergy or intolerance.

11. Is mentally incompetent. If questionable, obtain psychiatric consult.

12. Has a Waddell Signs of Inorganic Behavior score of 3 or greater.

13. Is a prisoner.

14. Is an alcohol and/or drug abuser as defined by currently undergoing treatment for alcohol and/or drug usage.

15. Is a tobacco user at the time of surgery.

16. Has received drugs which may interfere with bone metabolism within two weeks prior to the planned date of spinal fusion surgery (e.g., NSAIDS, steroids or methotrexate).

17. Has a history of autoimmune disease (Systemic Lupus Erythematosus or Dermatomyositis).

18. Has a history of hypersensitivity to protein pharmaceuticals (monoclonal antibodies or gamma globulins).

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/BCP implantation.

20. Has received any previous exposure to any/all BMPs of either human or animal extraction.

21. Has a history of severe allergy (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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Spinal and Biologics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

C-9805

Identifier Type: -

Identifier Source: org_study_id