NL-OMON47404
Completed
Phase 4
Prospective longitudinal outcome study assessing the use of REGENOSS for attaining spinal fusion in patients requiring single level Posterior Interbody Fusion (PLIF) in the lumbar spine. - REGENOSS posterior interbody fusion, pilot study
Finceramica0 sites24 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Finceramica
- Enrollment
- 24
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patients who signed the ethics committee approved specific informed consent prior to surgery.
- •2\. Male and non\-pregnant female patients between 18\-70 years of age.
- •3\. Patients with a BMI \<\<\= 35 Kg/m2
- •4\. Patients with low\-grade spondylolisthesis requiring single\-level or 2 level posterior interbody fusion at level L3\-L4 L4\-L5 or L5\-S1\.
- •5\. Patients who are physically and mentally willing and able to comply with postoperative functional evaluation.
- •6\. Patient can read and understand the Dutch language.
- •7\. If intra\-operatively the surgeons decided to fuse an additional level for spinal stability this is not an exclusion criteria however the primary level for surgical indication will be measured.
Exclusion Criteria
- •1\. Patients who are unwilling to cooperate with the study protocol and follow\-up schedule.
- •2\. Patients who, as judged by the surgeon, are mentally incompetent or are likely to be non\-compliant with the prescribed post\-operative routine and follow\-up evaluation schedule.
- •3\. Patients with bleeding history, hemophelia or systemic blood diseases
- •4\. Female patients that are pregnant or planning a pregnancy during the course of the study
- •5\. Obese patients where obesity is severe enough to affect subject\*s ability to perform activities of daily living (body mass index, kg/m2 \> 35\)
- •6\. Patients with active or suspected infection
- •7\. Patients with malignancy \* active malignancy within last 5 years
- •8\. Patients known with a diagnosed systemic disease that would affect the subject\*s welfare or overall outcome of the study (severe osteoporosis requiring medication, Paget\*s disease, renal osteodystrophy,hypercalcemia ) or is immunologically suppressed, or receiving steroids in excess of physiologic dose.
- •9\. Patients with a neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device or the patient has a neurological deficit which interferes with the patient\*s ability to limit weight bearing or places an extreme load on the implant during the healing period.
- •10\. Patients with systemic or metabolic disorders leading to progressive bone deterioration
Outcomes
Primary Outcomes
Not specified
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