Single Center Study Comparing MOBIS II ST vs MOBIS PEEK

Not Applicable

Withdrawn

• Conditions: Lumbar Disc Disease
• Interventions: Device: SIGNUS MOBIS PEEK Cage; Device: SIGNUS MOBIS II ST Cage

• Registration Number: NCT02852187
• Lead Sponsor: Signus Medizintechnik GmbH

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.

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-07-18
• Study First Submitted QC: 2016-07-28
• Study First Posted: 2016-08-02
• Primary Completion: 2018-11
• Study Completion: 2018-11
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-17
• Last Update Posted: 2020-03-19

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MOBIS PEEK	SIGNUS MOBIS PEEK Cage	Transforaminal Lumbar Interbody Fusion (TLIF) with the SIGNUS MOBIS PEEK Cage
MOBIS II ST	SIGNUS MOBIS II ST Cage	Transforaminal Lumbar Interbody Fusion (TLIF) with the SIGNUS MOBIS II ST Cage

Primary Outcome Measures

Name	Time	Method
Fusion rates	24 Months	Lumbar fusion demonstrated by radiographic evidence based on plain radiographs, and CT Scans

Secondary Outcome Measures

Name	Time	Method
Patient Reported Outcomes: Oswestry Disability Index	Through 24 Months	Comparison of pre-operative to post-operative evaluations
Patient Reported Outcomes: Visual Analog Scale (VAS)	Through 24 Months	Comparison of pre-operative to post-operative evaluations
Patient Reported Outcomes: Evaluations of Quality of Life (QOL) by the EQ-5D-5L	Through 24 Months	Comparison of pre-operative to post-operative evaluations
Subsidence	24 Months	disc height demonstrated by radiographic evidence based on plain radiographs, and CT Scans

Trial Locations

Locations (1)

Upstate Orthopedics; 🇺🇸 East Syracuse, New York, United States