Comparison of Radiographic Fusion Rate and Clinical Outcome of ALIF and XLIF Performed With Either Recombinant Human Bone Morphogenetic Protein-2 or ViviGen®

Browse trials for

• Spondylosis 144
• Spondylolisthesis 238
• Intervertebral Disc Degeneration 463

Keywords

• ViviGen
• Radiographic fusion rate
• Anterior lumbar interbody fusion
• Recombinant human bone morphogenetic protein-2
• Spondylosis
• Spondylolisthesis
• Degenerative Disc Disease
• Extreme lateral interbody fusion

Study arms

• Active comparator
  Intervention group 5-5.4 cc ViviGen®

  Biological: 5-5.4 cc ViviGen® The ALIF or XLIF fusion patients assigned to this group will receive 5-5.4 cc ViviGen®

  Other: ViviGen®

• Active comparator
  Control group 4-6mg rhBMP-2

  Biological: 4-6mg rhBMP-2 The ALIF or XLIF fusion patients assigned to this group will receive 4-6mg rhBMP-2

  Other: rhBMP-2

Interventions

• OtherViviGen®

  It will investigate the radiological and clinical outcome of ALIF procedure L5/S1 and XLIF L4/L5 procedure using two arms/ treatments, namely either ViviGen® Bone Matrix (intervention group) or rhBMP-2 (control group). ViviGen®/ rhBMP-2 ratio will be 1:1.

• OtherrhBMP-2

  It will investigate the radiological and clinical outcome of ALIF procedure L5/S1 and XLIF L4/L5 procedure using two arms/ treatments, namely either ViviGen® Bone Matrix (intervention group) or rhBMP-2 (control group). ViviGen®/ rhBMP-2 ratio will be 1:1.

  Also known as: InductOS

Primary outcomes

1. 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)

   The rate of interbody bony fusion will be assessed by computed tomography and then by a radiologist 6 or 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.

   Time frame: 6 or 12 months after intervention

Secondary outcomes

1. 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.

   Time frame: before intervention and at 6 weeks, 6 months and 12 months after intervention

2. 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.

   Time frame: before intervention and at 6 weeks, 6 months and 12 months after intervention

3. 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.

   Time frame: before intervention and at 6 weeks, 6 months and 12 months after intervention

4. 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.

   Time frame: before intervention and at 6 weeks, 6 months and 12 months after intervention

5. 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.

   Time frame: before intervention and at 6 weeks, 6 months and 12 months after intervention

6. 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.

   Time frame: 6 weeks, 6 months and 12 months after intervention

7. 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.

   Time frame: 14 days, 6 weeks, 6 months and 12 months after intervention

Other outcomes

1. 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.

   Time frame: 12 months after intervention

Publications

• 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. PubMed 8769465 ↗
• 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. PubMed 22241610 ↗
• 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. PubMed 32355628 ↗
• 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. PubMed 27909654 ↗
• 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. PubMed 30872148 ↗
• 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. PubMed 24026158 ↗
• 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. PubMed 33213484 ↗

Individual participant data

Plan to share: No