Single Center Study Comparing MOBIS II ST vs MOBIS PEEK

NCT ID: NCT02852187

Last Updated: 2020-03-19

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2018-11-30

Brief Summary

Prospective randomized clinical study comparing SIGNUS MOBIS PEEK vs SIGNUS MOBIS II ST in patients with Degenerative Disc Disease at one or two contiguous levels from L2-S1

Detailed Description

The protocol includes skeletally mature patients both male and female, 18 to 89 years old, with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients may also have up to a Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patient should have completed at least six (6) months of non-operative treatment. Patients may have had a previous non-fusion surgery at the involved spinal level(s) and will be followed clinically up to two years.

Conditions

Lumbar Disc Disease

Study Design

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

Study Groups

MOBIS PEEK

Transforaminal Lumbar Interbody Fusion (TLIF) with the SIGNUS MOBIS PEEK Cage

Group Type: ACTIVE_COMPARATOR

SIGNUS MOBIS PEEK Cage

Intervention Type: DEVICE

Lumbar Interbody Fusion

MOBIS II ST

Transforaminal Lumbar Interbody Fusion (TLIF) with the SIGNUS MOBIS II ST Cage

Group Type: ACTIVE_COMPARATOR

SIGNUS MOBIS II ST Cage

Intervention Type: DEVICE

Lumbar Interbody Fusion

Interventions

SIGNUS MOBIS PEEK Cage

Lumbar Interbody Fusion

Intervention Type: DEVICE

SIGNUS MOBIS II ST Cage

Lumbar Interbody Fusion

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. The patient has symptomatic degenerative disc disease (DDD) at one or two contiguous levels from L2-S1.

2. The patient has documented conservative (non-operative) treatment for at least 6 months.

3. The patient has a VAS back pain of ≥ 60 mm.

4. The patient has an ODI ≥ 40%.

5. The patient is at least 18 years of age and skeletally mature.

6. The general condition of the patient is appropriate for surgery, as evaluated by the Investigator.

7. The patient is willing and able to comply with study requirements.

8. The patient has agreed to participate in the study.

Exclusion Criteria

1. The patient has undergone any prior spinal fusion surgery at the proposed treatment level(s).

2. The patient has osteoporosis or severe osteopenia as determined by the Investigator. A clinical SCORE calculator may be utilized for females over 40 years of age.

3. The patient has grade 2 or higher spondylolisthesis or retrolisthesis at the affected level(s).

4. The patient has diffuse multilevel neoplastic disease such that no adjacent normal segments exist for engagement or instrumentation.

5. The patient has an active infection.

6. The patient is pregnant or is planning on becoming pregnant in the next two years.

7. The patient is mentally ill or has a history of drug abuse or severe depression/ psychosocial issues.

8. The patient has a known allergy to polyether ether ketone (PEEK), stainless steel or tantalum/titanium.

9. The patient is currently enrolled in an investigational spine study.

10. The patient has rheumatoid arthritis, ankylosing spondylitis or other autoimmune disease.

11. The patient has symptomatic fibrous arachnoiditis

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Signus Medizintechnik GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William F. Lavelle, MD

Role: PRINCIPAL_INVESTIGATOR

Upstate Orthopedics

Locations

Upstate Orthopedics

East Syracuse, New York, United States

Countries

United States

Other Identifiers

01MOBIS_US

Identifier Type: -

Identifier Source: org_study_id