Single Center Study Comparing MOBIS II ST vs MOBIS PEEK

Lumbar Disc Disease Clinical Trial

— MOBIS_US  

Official title:

Prospective, Randomized, Data Registry Study of MOBIS II Structural Titanium (ST) Interbody Cage Compared to MOBIS Peek Cage for the Treatment of Spondylolisthesis and Degenerative Disc Disease

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02852187
• Other study ID #: 01MOBIS_US
• Status: Withdrawn
• Phase: N/A
• Start date: July 2016
• Est. completion date: November 2018

Study information

• Verified date: March 2020
• Source: Signus Medizintechnik GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Lumbar Disc Disease
• Spinal Diseases

Intervention

Device:
• SIGNUS MOBIS PEEK Cage
Lumbar Interbody Fusion
• SIGNUS MOBIS II ST Cage
Lumbar Interbody Fusion

Locations

Country	Name	City	State
United States	Upstate Orthopedics	East Syracuse	New York

Sponsors (1)

Lead Sponsor	Collaborator
Signus Medizintechnik GmbH

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fusion rates	Lumbar fusion demonstrated by radiographic evidence based on plain radiographs, and CT Scans	24 Months
Secondary	Subsidence	disc height demonstrated by radiographic evidence based on plain radiographs, and CT Scans	24 Months
Secondary	Patient Reported Outcomes: Visual Analog Scale (VAS)	Comparison of pre-operative to post-operative evaluations	Through 24 Months
Secondary	Patient Reported Outcomes: Oswestry Disability Index	Comparison of pre-operative to post-operative evaluations	Through 24 Months
Secondary	Patient Reported Outcomes: Evaluations of Quality of Life (QOL) by the EQ-5D-5L	Comparison of pre-operative to post-operative evaluations	Through 24 Months