Early Clinical Results of Intervertebral Joint Stabilization by Injectable Load-Sharing Polymers
Thomas Hedman,1 James Yu,2 Harwant Singh,3 Timothy Deer4 1F. Joseph Halcomb III, M.D. Department of Biomedical Engineering, University of Kentucky, Lexington, KY, USA; 2Sydney Spine and Pain, Waratah Private Hospital, Hurstville, New South Wales, Australia; 3Spine and Joint Centre, Pantai Hospital,...
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| Format: | Article |
| Language: | English |
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Dove Medical Press
2023-08-01
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| Series: | Journal of Pain Research |
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| Online Access: | https://www.dovepress.com/early-clinical-results-of-intervertebral-joint-stabilization-by-inject-peer-reviewed-fulltext-article-JPR |
| _version_ | 1797745422457896960 |
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| author | Hedman T Yu J Singh H Deer T |
| author_facet | Hedman T Yu J Singh H Deer T |
| author_sort | Hedman T |
| collection | DOAJ |
| description | Thomas Hedman,1 James Yu,2 Harwant Singh,3 Timothy Deer4 1F. Joseph Halcomb III, M.D. Department of Biomedical Engineering, University of Kentucky, Lexington, KY, USA; 2Sydney Spine and Pain, Waratah Private Hospital, Hurstville, New South Wales, Australia; 3Spine and Joint Centre, Pantai Hospital, Kuala Lumpur, Malaysia; 4The Spine and Nerve Center of the Virginias, Charleston, WV, USACorrespondence: Thomas Hedman, Tel +1 512 818-8468, Email tomhedman@alum.mit.eduBackground: Genipin is a polymer-forming collagen bonding substance that can be dissolved in a buffered carrier and injected into disc annulus tissues. Therapeutic benefit is derived from the mechanical support provided by a large number of genipin polymers attached to collagen fibers in a degraded disc.Study Design/Setting: IRB-approved prospective, multi-site, single-arm, 12-month feasibility studies were undertaken in two countries to evaluate the safety and efficacy of the genipin-based implant for treating discogenic chronic low back pain (CLBP).Patient Sample: Twenty CLBP patients with symptomatic discs at one or two levels were enrolled in the study.Outcome Measures: The primary safety endpoint was serious adverse events at 1 month, and the primary efficacy endpoint was reduction of pain and disability at 3 months. Secondary efficacy endpoints included reduction of pain and disability at 2 weeks, 1 month, 6 months, and 12 months; reduction of flexion–extension instability; increase in segmental lordosis and rotation; and patient satisfaction.Methods: Fluoroscopic image-guidance was used to deliver two posterolateral injections of buffered genipin to each symptomatic disc. Flexion–extension radiographs were used to quantify joint kinematics at three time-points.Results: Clinically meaningful improvements in pain and disability scores were reported in 80% or more of patients from 2 weeks to 1 year post-treatment. For the more severely unstable joints, treatment significantly reduced the instability score from a pre-treatment level of 2.4 standard deviations above the mean for an asymptomatic population to the asymptomatic mean at the 3-month follow-up.Conclusion: These initial clinical data demonstrate the safety and efficacy of a genipin-based collagen tethering device capable of improving spinal joint stability while successfully addressing CLBP. This work merits additional randomized clinical studies.Keywords: disc disease, lumbar spine, collagen, degenerative disc disease |
| first_indexed | 2024-03-12T15:24:01Z |
| format | Article |
| id | doaj.art-ab79de0175ec475e99f5393d7318ea46 |
| institution | Directory Open Access Journal |
| issn | 1178-7090 |
| language | English |
| last_indexed | 2024-03-12T15:24:01Z |
| publishDate | 2023-08-01 |
| publisher | Dove Medical Press |
| record_format | Article |
| series | Journal of Pain Research |
| spelling | doaj.art-ab79de0175ec475e99f5393d7318ea462023-08-10T19:04:44ZengDove Medical PressJournal of Pain Research1178-70902023-08-01Volume 162777278985820Early Clinical Results of Intervertebral Joint Stabilization by Injectable Load-Sharing PolymersHedman TYu JSingh HDeer TThomas Hedman,1 James Yu,2 Harwant Singh,3 Timothy Deer4 1F. Joseph Halcomb III, M.D. Department of Biomedical Engineering, University of Kentucky, Lexington, KY, USA; 2Sydney Spine and Pain, Waratah Private Hospital, Hurstville, New South Wales, Australia; 3Spine and Joint Centre, Pantai Hospital, Kuala Lumpur, Malaysia; 4The Spine and Nerve Center of the Virginias, Charleston, WV, USACorrespondence: Thomas Hedman, Tel +1 512 818-8468, Email tomhedman@alum.mit.eduBackground: Genipin is a polymer-forming collagen bonding substance that can be dissolved in a buffered carrier and injected into disc annulus tissues. Therapeutic benefit is derived from the mechanical support provided by a large number of genipin polymers attached to collagen fibers in a degraded disc.Study Design/Setting: IRB-approved prospective, multi-site, single-arm, 12-month feasibility studies were undertaken in two countries to evaluate the safety and efficacy of the genipin-based implant for treating discogenic chronic low back pain (CLBP).Patient Sample: Twenty CLBP patients with symptomatic discs at one or two levels were enrolled in the study.Outcome Measures: The primary safety endpoint was serious adverse events at 1 month, and the primary efficacy endpoint was reduction of pain and disability at 3 months. Secondary efficacy endpoints included reduction of pain and disability at 2 weeks, 1 month, 6 months, and 12 months; reduction of flexion–extension instability; increase in segmental lordosis and rotation; and patient satisfaction.Methods: Fluoroscopic image-guidance was used to deliver two posterolateral injections of buffered genipin to each symptomatic disc. Flexion–extension radiographs were used to quantify joint kinematics at three time-points.Results: Clinically meaningful improvements in pain and disability scores were reported in 80% or more of patients from 2 weeks to 1 year post-treatment. For the more severely unstable joints, treatment significantly reduced the instability score from a pre-treatment level of 2.4 standard deviations above the mean for an asymptomatic population to the asymptomatic mean at the 3-month follow-up.Conclusion: These initial clinical data demonstrate the safety and efficacy of a genipin-based collagen tethering device capable of improving spinal joint stability while successfully addressing CLBP. This work merits additional randomized clinical studies.Keywords: disc disease, lumbar spine, collagen, degenerative disc diseasehttps://www.dovepress.com/early-clinical-results-of-intervertebral-joint-stabilization-by-inject-peer-reviewed-fulltext-article-JPRdisc diseaselumbar spinecollagendegenerative disc disease |
| spellingShingle | Hedman T Yu J Singh H Deer T Early Clinical Results of Intervertebral Joint Stabilization by Injectable Load-Sharing Polymers Journal of Pain Research disc disease lumbar spine collagen degenerative disc disease |
| title | Early Clinical Results of Intervertebral Joint Stabilization by Injectable Load-Sharing Polymers |
| title_full | Early Clinical Results of Intervertebral Joint Stabilization by Injectable Load-Sharing Polymers |
| title_fullStr | Early Clinical Results of Intervertebral Joint Stabilization by Injectable Load-Sharing Polymers |
| title_full_unstemmed | Early Clinical Results of Intervertebral Joint Stabilization by Injectable Load-Sharing Polymers |
| title_short | Early Clinical Results of Intervertebral Joint Stabilization by Injectable Load-Sharing Polymers |
| title_sort | early clinical results of intervertebral joint stabilization by injectable load sharing polymers |
| topic | disc disease lumbar spine collagen degenerative disc disease |
| url | https://www.dovepress.com/early-clinical-results-of-intervertebral-joint-stabilization-by-inject-peer-reviewed-fulltext-article-JPR |
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