Evidence For Fusion In Spine With Orthoss®

Status: Active_not_recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Observational
SUMMARY

This study aims to evaluate the performance and safety of the Orthoss® as a bone graft extender in lumbar spondylodesis involving 1-2 levels (L4-L5 and/or L5-S1).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• The patient (male or female) must be 18 years or older

• The patient must be a candidate diagnosed with either degenerative disc disease including 1-2 level (L4-L5 and/or L5-S1) or dysplasic spondylolisthesis (degree 1 or 2) or lumbar stenosis

• If the patient is of child-bearing potential, the patient confirms not to be pregnant

• The patient is able to comply with the clinical investigation-related procedures such as attending all follow-up procedures

• The patient is able to fully understand the nature of the proposed surgery and is able to provide a signed informed consent including the use of the anonymized data for scientific publication

• The patient will not participate in another clinical investigation during this clinical investigation

Locations
Other Locations
Germany
Universitätsklinikum Augsburg - Neurochirurgische Klinik und Poliklinik
Augsburg
Universitätsklinikum Düsseldorf
Düsseldorf
Klinikum Magdeburg gGmbH
Magdeburg
Time Frame
Start Date: 2019-01-18
Completion Date: 2027-01
Participants
Target number of participants: 65
Treatments
Lumbar spondylodesis involving 1-2 levels (L4-L5 and/or L5-S1)
All surgical procedures to be performed during this clinical trial are part of the routine procedures for lumbar spondylodesis by using transforaminal lumbar interbody fusion (TLIF) and posterior lumbar interbody fusion (PLIF) techniques in the 1-2 levels (L4-L5 and/or L5-S1). Patients will receive surgery according to standard procedures.
Sponsors
Leads: Geistlich Pharma AG

This content was sourced from clinicaltrials.gov