on-interventional study (post-marketing clinical follow-up) of lumbar interbody fusion with an EndoLIF® Oblique Cage

Recruiting

Conditions: M51.0
M43.16
M51.3
M43.17
Lumbar and other intervertebral disc disorders with myelopathy
Other specified intervertebral disc degeneration

Registration Number: DRKS00007785

Lead Sponsor: joimax GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 52

Inclusion Criteria

Patients for whom the clinical indications for implantation of an EndoLIF® O-Cage were the diagnosis of degenerative lumbar disc disease (M51.0 - M51.3) and spondylolisthesis (M43.16 or M43.17).
Age 18 - 75 years

Exclusion Criteria

•Patients who are unable to give their consent due, e.g. to cognitive impairment.
•Pregnancy
•Active infection
•An allergy to titanium
•Patients with serious conditions (cancer, heart failure NYHA II or worse, diseases which irreversibly lead to stage ASA III and IV, drug or alcohol abuse, known severe blood clotting abnormalities, peripheral occlusive disease = stage IIb, severe polyneuropathy)
•No patient consent, particularly for patients who did not agree to a 24-month study follow-up
•Patients with fractures of the lumbar spine or in adjacent segments
•BMI > 40 kg/m2
•Soft tissue defects in the area of the planned surgical access route
•Serious diseases of the spine (e.g., osteoarthritis, osteopenia, osteoporosis or osteomalacia)
•Increased fracture risk (systemic or local)
•Diseases with a consecutively decreasing fusion rate
•Congenital malformations of the spine

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoints are postoperative pain patterns, physical quality of life, physical capacity and satisfaction after lumbar interbody fusion with the EndoLIF Oblique Cage.<br>The above criteria will be rated preoperatively, postoperatively after 2 and 6 weeks, and at 6, 12 and 24 months.<br>The criteria will be rated using questionnaires (SF12, Oswestry (ODI) and visual analogue scales (VAS)).<br>

Secondary Outcome Measures

Name	Time	Method
The objective is to report radiological success rates after lumbar interbody fusion with an EndoLIF® Oblique Cage.<br><br>Radiological success is defined as evidence measured by computed tomography of a correctly positioned cage, evidence of fusion and that migration has taken place, with no more than usual sintering and without pseudarthrosis.<br><br><br>Achievements will be assessed by means of routinely performed x-rays or CT scans. The timing of radiological examinations will not be stipulated by the study, but performed according to medical indication.<br>