Investigation of ossification capability and clinical outcome after fusion surgery of a vertebral segment in the lumbar region, a prospective, randomized, and blinded study
Zusammenfassung der Studie
In spinal diseases that lead to back and/or leg pain, a possible treatment is the fusion of the affected segments of the spine. This can be done through surgery via the abdominal wall from the front (a technique called Anterior Lumbar Interbody Fusion or ALIF technique) or from the side (a technique called eXtreme lateral Lumbar Interbody Fusion or XLIF technique). The fusion is achieved through ossification between the vertebral bodies. To enhance bone formation, we use, as a standard therapy, a bone-forming protein (protein, manufacturer name InductOS). When using this protein, side effects may occur after the operation, e.g., temporarily prolonged leg pain. As an alternative to InductOS, we use a bone graft from a bone donation with bone structure and bone-forming cells (manufacturer name ViviGen®). In this study, we investigate whether the bone graft ViviGen® can achieve equally good stable ossification as the bone-forming protein InductOS.
(BASEC)
Untersuchte Intervention
The division into two study groups is planned and will occur equally in a 1:1 ratio. One group will receive InductOS, the other group will receive ViviGen® during surgery.
(BASEC)
Untersuchte Krankheit(en)
Eligible participants are all individuals aged between 18 and 70 years who suffer from back or leg pain or sciatica, and in whom explanatory changes in the spinal segment (segment = two adjacent vertebral bodies) L5/S1 or L4/L5 are diagnosed. Such a change can be the following: vertebral slippage (spondylolisthesis), disc degeneration, facet joint osteoarthritis (segment degeneration = wear) and/or narrowing of the spinal canal/nerve root (spinal/foraminal stenosis).
(BASEC)
- The patient has an indication for performing a monosegmental ALIF procedure at the L5/S1 segment or a monosegmental XLIF procedure at L4/5 (both ALIF and XLIF procedures with or without additional pedicular stabilization), e.g., for the treatment of conditions such as spondylosis, spondylolisthesis, and degenerative disc disease with back and/or leg pain - The patient is 18 to 70 years old - The patient has understood and signed the patient information and consent form - The patient is willing and able to complete the planned follow-up examinations/questionnaires as described in the patient information - (BASEC)
Ausschlusskriterien
- The patient is under 18 years old or over 70 years old - The patient has a tumor / spinal trauma / known bone disease / Parkinson's disease and similar CNS disorders / diseases or injuries of the peripheral nerves - Other than the procedures or segments mentioned in the inclusion criteria - Additional planned spinal surgeries after the index operation - The patient is currently a smoker - The patient is pregnant or breastfeeding - Insufficient language skills in German - The patient is unable to give consent - Patient refuses to participate in the study, unsigned study consent - The patient is participating in another interventional study within 30 days prior to and during the present study (BASEC)
Studienstandort
Bern
(BASEC)
Sponsor
Forschungszentrum Lindenhofgruppe Hochfeldstrasse 41 3012 Bern
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Dr. med. Peter Diel
+41 31 358 17 90
peterdiel@cluttersonnenhof.chOrthopädie Sonnenhof
(BASEC)
Allgemeine Auskünfte
Orthop?die Sonnenhof, Bern,
+41 31 358 17 90;+41 31 358 17 90
peterdiel@cluttersonnenhof.ch(ICTRP)
Wissenschaftliche Auskünfte
Orthop?die Sonnenhof, Bern,
+41 31 358 17 90;+41 31 358 17 90
peterdiel@cluttersonnenhof.ch(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Bern
(BASEC)
Datum der Bewilligung durch die Ethikkommission
17.06.2022
(BASEC)
ICTRP Studien-ID
NCT05238740 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
Comparison of radiographic fusion rate and clinical outcome of anterior lumbar and extreme lateral interbody fusion performed with either recombinant human bone morphogenetic protein-2 or ViviGen® Cellular Bone Matrix, a prospective randomised assessor blind, monocentric trial (BASEC)
Wissenschaftlicher Titel
Comparison of Radiographic Fusion Rate and Clinical Outcome of Anterior Lumbar and Extreme Lateral Interbody Fusion Performed with Either Recombinant Human Bone Morphogenetic Protein-2 or ViviGen? Cellular Bone Matrix, a Prospective Randomised Assessor Blind, Monocentric Trial (ICTRP)
Öffentlicher Titel
Comparison of Radiographic Fusion Rate and Clinical Outcome of ALIF and XLIF Performed with Either Recombinant Human Bone Morphogenetic Protein-2 or ViviGen? (ICTRP)
Untersuchte Krankheit(en)
Spondylosis;Spondylolisthesis;Degenerative Disc Disease (ICTRP)
Untersuchte Intervention
Other: ViviGen?;Other: rhBMP-2 (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: Single (Outcomes Assessor). (ICTRP)
Ein-/Ausschlusskriterien
Gender: All
Maximum age: 70 Years
Minimum age: 18 Years
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 smokingPregnant or breastfeeding patients
- 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 (ICTRP)
nicht verfügbar
Primäre und sekundäre Endpunkte
Rate of interbody bony fusion in the treated patients confirmed at 12-month CT or earlier at 6-month CT using Brantigan, Steffee, Fraser (BSF) (ICTRP)
Back pain visual analogue scale;Leg pain visual analogue scale;Quality of life using a simplified Spine Tango questionnaire and the Core Outcome Measures Index (COMI Score);Disability/ limitations in the activities of daily living using a simplified Spine Tango questionnaire and the Core Outcome Measures Index (COMI Score);Disability/ limitations at the workplace using a simplified Spine Tango questionnaire and the Core Outcome Measures Index (COMI Score);Patient satisfaction using a simplified Spine Tango questionnaire and the Core Outcome Measures Index (COMI Score);Complication / side effects using a simplified Spine Tango questionnaire and the Core Outcome Measures Index (COMI Score) (ICTRP)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
Diel Peter, Dr. med.;Diel Peter, Dr. med;Peter Diel, Dr.med., peter.diel@sonnenhof.ch, +41 31 358 17 90;+41 31 358 17 90, Orthop?die Sonnenhof, Bern, (ICTRP)
Sekundäre IDs
2021-02219 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT05238740 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar