NCT05238740 Comparison of Radiographic Fusion Rate and Clinical Outcome of ALIF and XLIF Performed With Either Recombinant Human Bone Morphogenetic Protein-2 or ViviGen®
| NCT ID | NCT05238740 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Lindenhofgruppe AG |
| Condition | Spondylosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 168 participants |
| Start Date | 2022-10-27 |
| Primary Completion | 2032-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 168 participants in total. It began in 2022-10-27 with a primary completion date of 2032-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The aim of this study is to prospectively investigate the potential for bony fusion of ViviGen® bone graft substitute in comparison to rhBMP-2 in monosegmental ALIF procedure L5/S1 and in monosegmental XLIF procedure L4/5
Eligibility Criteria
Inclusion criteria: Patients who have an indication for a monosegmental ALIF procedure on the L5/S1 segment or a monosegmental XLIF procedure on L4/5 (both ALIF and XLIF procedure with or without an additional pedicular stabilisation), e.g., treating conditions such as spondylosis, spondylolisthesis and degenerative disc disorders with back and/or leg pain * Patients must be 18 - 70 years of age * Patients must have understood and signed the study information and the informed consent form * Patients are willing and able to complete scheduled follow-up evaluations / questionnaires as described in the Informed Consent Exclusion criteria: * Patients under 18 years and over 70 years of age * Patients with tumour / spine trauma / known bone disease / Parkinson's disease and similar CNS disorders / diseases or injuries of the peripheral nerves * Other procedures or segment than mentioned in the inclusion citeriaAdditional planed spine surgeries after index surgery * Current smoking * Pregnant or breastfeeding patients (or patient planning a pregnancy within one year after surgery) * Insufficient language skills in German * Inability to give informed consent * Refusal to participate in the study, unsigned study consent * Participation in another interventional study within the 30 days preceding and during the present study
Contact & Investigator
Diel Peter, Dr. med.
PRINCIPAL INVESTIGATOR
Orthopädie Sonnenhof, Bern
Frequently Asked Questions
Who can join the NCT05238740 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Spondylosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05238740 currently recruiting?
Yes, NCT05238740 is actively recruiting participants. Contact the research team at peter.diel@sonnenhof.ch for enrollment information.
Where is the NCT05238740 trial being conducted?
This trial is being conducted at Bern, Switzerland.
Who is sponsoring the NCT05238740 clinical trial?
NCT05238740 is sponsored by Lindenhofgruppe AG. The principal investigator is Diel Peter, Dr. med. at Orthopädie Sonnenhof, Bern. The trial plans to enroll 168 participants.