Twenty-four-month interim results from a prospective, single-arm clinical trial evaluating the performance and safety of cellular bone allograft in patients undergoing lumbar spinal fusion
Abstract Background Autologous bone grafts are the gold standard for spinal fusion; however, harvesting autologous bone can result in donor site infection, hematomas, increased operative time, and prolonged pain. Cellular bone allografts (CBAs) are a viable alternative that avoids the need for bone...
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| Format: | Article |
| Language: | English |
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BMC
2023-11-01
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| Series: | BMC Musculoskeletal Disorders |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s12891-023-06996-5 |
| _version_ | 1797578630686048256 |
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| author | Daniel K. Park Joshua J. Wind Todd Lansford Pierce Nunley Timothy A. Peppers Anthony Russo Hamid Hassanzadeh Jonathan Sembrano Jung Yoo Jonathan Sales |
| author_facet | Daniel K. Park Joshua J. Wind Todd Lansford Pierce Nunley Timothy A. Peppers Anthony Russo Hamid Hassanzadeh Jonathan Sembrano Jung Yoo Jonathan Sales |
| author_sort | Daniel K. Park |
| collection | DOAJ |
| description | Abstract Background Autologous bone grafts are the gold standard for spinal fusion; however, harvesting autologous bone can result in donor site infection, hematomas, increased operative time, and prolonged pain. Cellular bone allografts (CBAs) are a viable alternative that avoids the need for bone harvesting and may increase fusion success alone or when used as an adjunct material. The present study examined the efficacy and safety of CBA when used as an adjunct graft material to lumbar arthrodesis. Methods A prospective, single-arm, multicenter clinical trial (NCT 02969616) was conducted in adult subjects (> 18 years of age) undergoing lumbar spinal fusion with CBA graft (CBA used as primary (≥ 50% by volume), with augmentation up to 50%). Radiographic fusion status was assessed by an independent review of dynamic radiographs and CT scans. Clinical outcomes were assessed with the Oswestry Disability Index (ODI), and Visual Analog Scales (VAS) score for back and leg pain. Adverse events were assessed through the 24-month follow-up period. The presented data represents an analysis of available subjects (n = 86) who completed 24 months of postoperative follow-up at the time the data was locked for analysis. Results Postoperative 24-month fusion success was achieved in 95.3% of subjects (n = 82/86) undergoing lumbar spinal surgery. Clinical outcomes showed statistically significant improvements in ODI (46.3% improvement), VAS-Back pain (75.5% improvement), and VAS-Leg pain (85.5% improvement) (p < 0.01) scores at Month 24. No subject characteristics or surgical factors were associated with pseudoarthrosis. A favorable safety profile with a limited number of adverse events was observed. Conclusions The use of CBA as an adjunct graft material showed high rates of successful lumbar arthrodesis and significant improvements in pain and disability scores. CBA provides an alternative to autograft with comparable fusion success rates and clinical benefits. Trial registration NCT 02969616. |
| first_indexed | 2024-03-10T22:25:32Z |
| format | Article |
| id | doaj.art-d16056a80b91468ca2ea0f7b0214ea67 |
| institution | Directory Open Access Journal |
| issn | 1471-2474 |
| language | English |
| last_indexed | 2024-03-10T22:25:32Z |
| publishDate | 2023-11-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Musculoskeletal Disorders |
| spelling | doaj.art-d16056a80b91468ca2ea0f7b0214ea672023-11-19T12:08:27ZengBMCBMC Musculoskeletal Disorders1471-24742023-11-012411710.1186/s12891-023-06996-5Twenty-four-month interim results from a prospective, single-arm clinical trial evaluating the performance and safety of cellular bone allograft in patients undergoing lumbar spinal fusionDaniel K. Park0Joshua J. Wind1Todd Lansford2Pierce Nunley3Timothy A. Peppers4Anthony Russo5Hamid Hassanzadeh6Jonathan Sembrano7Jung Yoo8Jonathan Sales9Beaumont HospitalSibley Memorial HospitalSouth Carolina Sports MedicineSpine Institute of LouisianaScripps Memorial Hospital EncinitasYellowstone Orthopedic and Spine Institute, Billings Clinic Bozeman John Hopkins MedicineUniversity of MinnesotaOregon Health and Science UniversitySummit SpineAbstract Background Autologous bone grafts are the gold standard for spinal fusion; however, harvesting autologous bone can result in donor site infection, hematomas, increased operative time, and prolonged pain. Cellular bone allografts (CBAs) are a viable alternative that avoids the need for bone harvesting and may increase fusion success alone or when used as an adjunct material. The present study examined the efficacy and safety of CBA when used as an adjunct graft material to lumbar arthrodesis. Methods A prospective, single-arm, multicenter clinical trial (NCT 02969616) was conducted in adult subjects (> 18 years of age) undergoing lumbar spinal fusion with CBA graft (CBA used as primary (≥ 50% by volume), with augmentation up to 50%). Radiographic fusion status was assessed by an independent review of dynamic radiographs and CT scans. Clinical outcomes were assessed with the Oswestry Disability Index (ODI), and Visual Analog Scales (VAS) score for back and leg pain. Adverse events were assessed through the 24-month follow-up period. The presented data represents an analysis of available subjects (n = 86) who completed 24 months of postoperative follow-up at the time the data was locked for analysis. Results Postoperative 24-month fusion success was achieved in 95.3% of subjects (n = 82/86) undergoing lumbar spinal surgery. Clinical outcomes showed statistically significant improvements in ODI (46.3% improvement), VAS-Back pain (75.5% improvement), and VAS-Leg pain (85.5% improvement) (p < 0.01) scores at Month 24. No subject characteristics or surgical factors were associated with pseudoarthrosis. A favorable safety profile with a limited number of adverse events was observed. Conclusions The use of CBA as an adjunct graft material showed high rates of successful lumbar arthrodesis and significant improvements in pain and disability scores. CBA provides an alternative to autograft with comparable fusion success rates and clinical benefits. Trial registration NCT 02969616.https://doi.org/10.1186/s12891-023-06996-5Lumbar fusionArthrodesisCellular allograftTrinity EliteCBA |
| spellingShingle | Daniel K. Park Joshua J. Wind Todd Lansford Pierce Nunley Timothy A. Peppers Anthony Russo Hamid Hassanzadeh Jonathan Sembrano Jung Yoo Jonathan Sales Twenty-four-month interim results from a prospective, single-arm clinical trial evaluating the performance and safety of cellular bone allograft in patients undergoing lumbar spinal fusion BMC Musculoskeletal Disorders Lumbar fusion Arthrodesis Cellular allograft Trinity Elite CBA |
| title | Twenty-four-month interim results from a prospective, single-arm clinical trial evaluating the performance and safety of cellular bone allograft in patients undergoing lumbar spinal fusion |
| title_full | Twenty-four-month interim results from a prospective, single-arm clinical trial evaluating the performance and safety of cellular bone allograft in patients undergoing lumbar spinal fusion |
| title_fullStr | Twenty-four-month interim results from a prospective, single-arm clinical trial evaluating the performance and safety of cellular bone allograft in patients undergoing lumbar spinal fusion |
| title_full_unstemmed | Twenty-four-month interim results from a prospective, single-arm clinical trial evaluating the performance and safety of cellular bone allograft in patients undergoing lumbar spinal fusion |
| title_short | Twenty-four-month interim results from a prospective, single-arm clinical trial evaluating the performance and safety of cellular bone allograft in patients undergoing lumbar spinal fusion |
| title_sort | twenty four month interim results from a prospective single arm clinical trial evaluating the performance and safety of cellular bone allograft in patients undergoing lumbar spinal fusion |
| topic | Lumbar fusion Arthrodesis Cellular allograft Trinity Elite CBA |
| url | https://doi.org/10.1186/s12891-023-06996-5 |
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