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.

Phase 4

Completed

• Conditions: spondylolisthesis; 10005944

• Registration Number: NL-OMON47404
• Lead Sponsor: Finceramica

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 24

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
11. Patients with other concurrent illnesses that are likely to affect their outcome such as all autoimmune diseases (including RA), sickle cell anaemia, systemic lupus erythematosus, psoriasis, not controlled type 1/2 diabetes or renal disease requiring dialysis.
12. Patients with a known sensitivity to device materials
13. Is an alcohol and/or drug abuser as defined by currently undergoing treatment for alcohol and/or drug abuse
14. Has received drugs that may interfere with bone metabolism within two weeks prior to the planned surgery date (e.g., steroids or methotrexate) excluding routine perioperative, non-steroidal anti-inflammatory drugs.
15. Any prior surgical treatment at the surgical level in the lower lumbar spine
16. Has chronic or acute renal and/or hepatic failure or prior history of renal or hepatic disease.
17. Below 18 and over 70 years of age.
18. Known allergies to collagen of equine origin and to calcium phosphate salts
19. If per *operative fusion of 2 levels is necessary, this will not be a reason for exclusion

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified