Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05238740
Other study ID # 2021-02219
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 27, 2022
Est. completion date November 2026

Study information

Verified date January 2024
Source Lindenhofgruppe AG
Contact Diel Peter, Dr. med
Phone +41 31 358 17 90
Email peter.diel@sonnenhof.ch
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 standalone ALIF procedure L5/S1


Description:

The investigator hypothesize that the intervention group administered ViviGen® would, following surgery, experience: - Comparable bony fusion rates, evaluated via CT scan one year postoperatively - Comparable clinical outcome/ simplified COMI-score one year postoperatively - Comparable/ less inpatient length of stay (LOS) - Comparable/ less healthcare costs one year postoperatively For patients included in the study, all follow-up is recorded, with regards to radiological and clinical outcome. Follow up will be evaluated after 14 days, 6 weeks, 6 and 12 months. Last follow up will be 1 year after surgery.


Recruitment information / eligibility

Status Recruiting
Enrollment 168
Est. completion date November 2026
Est. primary completion date November 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: Patients that present the indication for performing ALIF procedure L5/S1 (incl. stabilizations), 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 of age - Patients with tumor/ spine trauma/ known bone disease / parkinsons disease and similar central nervous system (CNS) disorders / diseases or injuries of the peripheral nerves - Other procedures than ALIF and other lumbar segments than L5/S1 - Current Smoking - Pregnant or breastfeeding patients - inadequate 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

Study Design


Intervention

Other:
ViviGen®
It will investigate the radiological and clinical outcome of stand-alone ALIF procedure L5/S1 using two arms/ treatments, namely either ViviGen® Bone Matrix (intervention group) or rhBMP-2 (control group). ViviGen®/ rhBMP-2 ratio will be 1:1.
rhBMP-2
It will investigate the radiological and clinical outcome of stand-alone ALIF procedure L5/S1 using two arms/ treatments, namely either ViviGen® Bone Matrix (intervention group) or rhBMP-2 (control group). ViviGen®/ rhBMP-2 ratio will be 1:1.

Locations

Country Name City State
Switzerland Orthopädie Sonnenhof Bern

Sponsors (1)

Lead Sponsor Collaborator
Lindenhofgruppe AG

Country where clinical trial is conducted

Switzerland, 

References & Publications (7)

Arrington ED, Smith WJ, Chambers HG, Bucknell AL, Davino NA. Complications of iliac crest bone graft harvesting. Clin Orthop Relat Res. 1996 Aug;(329):300-9. doi: 10.1097/00003086-199608000-00037. — View Citation

Birmingham E, Niebur GL, McHugh PE, Shaw G, Barry FP, McNamara LM. Osteogenic differentiation of mesenchymal stem cells is regulated by osteocyte and osteoblast cells in a simplified bone niche. Eur Cell Mater. 2012 Jan 12;23:13-27. doi: 10.22203/ecm.v023a02. — View Citation

Johnstone B, Zhang N, Waldorff EI, Semler E, Dasgupta A, Betsch M, Punsalan P, Cho H, Ryaby JT, Yoo J. A Comparative Evaluation of Commercially Available Cell-Based Allografts in a Rat Spinal Fusion Model. Int J Spine Surg. 2020 Apr 30;14(2):213-221. doi: 10.14444/7026. eCollection 2020 Apr. — View Citation

Kadam A, Millhouse PW, Kepler CK, Radcliff KE, Fehlings MG, Janssen ME, Sasso RC, Benedict JJ, Vaccaro AR. Bone substitutes and expanders in Spine Surgery: A review of their fusion efficacies. Int J Spine Surg. 2016 Sep 22;10:33. doi: 10.14444/3033. eCollection 2016. — View Citation

Manzur M, Virk SS, Jivanelli B, Vaishnav AS, McAnany SJ, Albert TJ, Iyer S, Gang CH, Qureshi S. The rate of fusion for stand-alone anterior lumbar interbody fusion: a systematic review. Spine J. 2019 Jul;19(7):1294-1301. doi: 10.1016/j.spinee.2019.03.001. Epub 2019 Mar 11. — View Citation

Singh K, Ahmadinia K, Park DK, Nandyala SV, Marquez-Lara A, Patel AA, Fineberg SJ. Complications of spinal fusion with utilization of bone morphogenetic protein: a systematic review of the literature. Spine (Phila Pa 1976). 2014 Jan 1;39(1):91-101. doi: 10.1097/BRS.0000000000000004. — View Citation

Wetzell B, McLean JB, Moore MA, Kondragunta V, Dorsch K. A large database study of hospitalization charges and follow-up re-admissions in US lumbar fusion surgeries using a cellular bone allograft (CBA) versus recombinant human bone morphogenetic protein-2 (rhBMP-2). J Orthop Surg Res. 2020 Nov 19;15(1):544. doi: 10.1186/s13018-020-02078-7. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Healthcare-costs using hospitalisation length of stay (LOS), occurrence and therapy of side effects/ adverse events and necessary revision operations Healthcare-costs will be assessed by using hospitalisation length of stay (LOS), occurrence and therapy of side effects/ adverse events and necessary revision operations at 12 months after intervention. 12 months after intervention
Primary Rate of interbody bony fusion in the lumbar segment L5/S1 using Brantigan, Steffee, Fraser (BSF) The rate of interbody bony fusion will be assessed by computed tomography and then by a radiologist 12 months after the intervention.
Modified Brantigan, Steffee, Fraser (BSF) classification of interbody fusion success will be defined as follows:
BSF-1: Radiographical pseudarthrosis is indicated by collapse of the construct, loss of disc height, vertebral slip, broken screws, displacement of the Synfix cage, or significant resorption of the bone graft, or lucency visible around the periphery of the graft or cage.
BSF-2: Radiographical locked pseudarthrosis is indicated by lucency visible in the middle of the cages with solid bone growing into the cage from each vertebral endplate.
BSF-3: Radiographical fusion: bone bridges at least half of the fusion area with at least the density originally achieved at surgery. Radiographical fusion through one cage (half of the fusion area) is considered to be mechanically solid fusion even if there is lucency on the opposite side.
12 months after intervention
Secondary Back pain visual analogue scale The back pain visual analogue scale (VAS 1-10) will be assessed before intervention and at 6 weeks, 6 months and 12 months after intervention. before intervention and at 6 weeks, 6 months and 12 months after intervention
Secondary Leg pain visual analogue scale The leg pain visual analogue scale (VAS 1-10) will be assessed before intervention and at 6 weeks, 6 months and 12 months after intervention. before intervention and at 6 weeks, 6 months and 12 months after intervention
Secondary Quality of life using a simplified Spine Tango questionnaire and the Core Outcome Measures Index (COMI Score) Quality of life will be assessed by using a simplified Spine Tango questionnaire and the Core Outcome Measures Index (COMI Score) before intervention and at 6 weeks, 6 months and 12 months after intervention. before intervention and at 6 weeks, 6 months and 12 months after intervention
Secondary Disability/ limitations in the activities of daily living using a simplified Spine Tango questionnaire and the Core Outcome Measures Index (COMI Score) Disability / limitations in the activities of daily living will be assessed by using a simplified Spine Tango questionnaire and the Core Outcome Measures Index (COMI Score) before intervention and at 6 weeks, 6 months and 12 months after intervention. before intervention and at 6 weeks, 6 months and 12 months after intervention
Secondary Disability/ limitations at the workplace using a simplified Spine Tango questionnaire and the Core Outcome Measures Index (COMI Score) Disability / limitations at the workplace will be assessed by using a simplified Spine Tango questionnaire and the Core Outcome Measures Index (COMI Score) before intervention and at 6 weeks, 6 months and 12 months after intervention. before intervention and at 6 weeks, 6 months and 12 months after intervention
Secondary Patient satisfaction using a simplified Spine Tango questionnaire and the Core Outcome Measures Index (COMI Score) Patient satisfaction will be assessed by using a simplified Spine Tango questionnaire and the Core Outcome Measures Index (COMI Score) at 6 weeks, 6 months and 12 months after intervention. 6 weeks, 6 months and 12 months after intervention
Secondary Complication / side effects using a simplified Spine Tango questionnaire and the Core Outcome Measures Index (COMI Score) Complication / side effects will be assessed by using a simplified Spine Tango questionnaire and the Core Outcome Measures Index (COMI Score) at 14 days, 6 weeks, 6 months and 12 months after intervention. 14 days, 6 weeks, 6 months and 12 months after intervention
See also
  Status Clinical Trial Phase
Recruiting NCT04848376 - Post-Market Clinical Follow-up Study of A-SPINE's Products
Active, not recruiting NCT05114135 - TLIF Osteo3 ZP Putty Study (Also Known as the TOP Fusion Study) N/A
Suspended NCT04735185 - Stem Cells vs. Steroids for Discogenic Back Pain N/A
Withdrawn NCT03223701 - Efficacy of Using Solum IV and BMC With GFC in TLIF Phase 4
Completed NCT04057235 - Retrospective Review of Integrity Implants FlareHawk® for Lumbar Fusion
Not yet recruiting NCT06000319 - Natural Matrix Protein™ (NMP™) Fibers in Cervical and Lumbar Interbody Fusion
Active, not recruiting NCT02969616 - Trinity Elite in Lumbar Fusion
Completed NCT02558621 - New Robotic Assistance System for Spinal Fusion Surgery N/A
Completed NCT02104167 - Retrospective/Prospective Data Collection on the LDR ROIC Interbody Fusion Device With VerteBRIDGE Plating
Completed NCT00965380 - Trinity Evolution in Posterior or Transforaminal Lumbar Interbody Fusion (PLIF/TLIF)
Terminated NCT00974623 - Bone Graft Materials Observational Registry N/A
Completed NCT00996073 - Safety and Preliminary Efficacy Study of NeoFuse in Subjects Requiring Lumbar Interbody Fusion Phase 2
Completed NCT00758719 - Evaluate Effectiveness of the Biomet Lumbar Spinal Fusion System
Completed NCT00165893 - Comparison of IDD Therapy and Non-surgical Treatment for Low Back Pain Caused by Degenerative Disc Disease Phase 4
Terminated NCT01494493 - Pivotal Study of rhBMP-2/ACS/Allograft Bone Dowel for Anterior Lumbar Interbody Fusion in Patients With Symptomatic Degenerative Disc Disease N/A
Recruiting NCT04727385 - Intervertebral DXM Gel Injection in Adults With Painful Lumbar Degenerative Disc Disease N/A
Completed NCT04849429 - Intra-discal Injection of Platelet-rich Plasma (PRP) Enriched With Exosomes in Chronic Low Back Pain Phase 1
Recruiting NCT04469387 - Preventive Effect of Limited Decompression on Adjacent Segment Following Posterior Lumbar Interbody Fusion N/A
Recruiting NCT04056520 - Clinical and Radiological Outcomes of Posterior Cervical Fusion With Medtronic Infinity Occipitocervical-Upper Thoracic (OCT) System
Completed NCT04119466 - Stabilizing Training in Degenerative Disc Disease N/A