Reduction of radiculopathy and pain with Oxiplex/SP Gel after laminectomy, laminotomy, and discectomy: A pilot clinical study

Kee D Kim, Jeffrey C. Wang, Daniel P. Robertson, Darrel S. Brodke, Erik M. Olson, Arthur C. Duberg, Mohammed BenDebba, Kathleen M. Block, Gere S. DiZerega, Thomas B. Ducker

Research output: Contribution to journalArticle

41 Citations (Scopus)

Abstract

Study Design. Safety using Oxiplex/SP Gel during single-level discectomy for reduction of symptoms associated with unilateral herniation of the lumbar disc was investigated by self-assessment questionnaire and magnetic resonance imaging. Objective. To evaluate the safety and assess the efficacy parameters of Oxiplex/SP Gel. Summary of Background Data. Animal studies demonstrated that Oxiplex/SP Gel (CMC/PEO) reduced epidural fibrosis after lumbar surgery. Methods. Surgeons examined spine and lower extremities of patients scheduled for discectomy to assess neurologic function and pain. Treated patients received sufficient Oxiplex/SP Gel (1-3 mL) to coat the nerve root and fill the epidural space. The control condition was surgery alone. At baseline, then 30 days, 90 days, and 6 months after surgery, patients completed self-assessment questionnaires concerning leg pain, lower extremity weakness, functional disability, daily living activities, symptoms, and radiculopathy. Magnetic resonance imaging was performed at baseline and 90 days after surgery. At 30 and 90 days after surgery, patients underwent physical examination, wound inspection, and laboratory tests. Results. The surgical procedures were well tolerated by the 23 patients treated with Oxiplex/SP Gel and the 11 control patients. There were no unanticipated adverse events, no clinically-significant laboratory results, and no significant differences detected by magnetic resonance imaging. Treated patients had greater reduction in outcome measures at 30 days. The differences in scores were attenuated at 90 days and 6 months. A subgroup, the patients with significant leg pain and weakness at baseline (11 patients treated with Oxiplex/SP Gel and 7 control patients), had greater reduction in outcome measures than the control patients throughout the study. Conclusions. Oxiplex/SP Gel was easy to use and safe for patients undergoing unilateral discectomy. Greater benefit in clinical outcome measures was seen in geltreated patients, especially those with severe leg pain and weakness at baseline.

Original languageEnglish (US)
Pages (from-to)1080-1088
Number of pages9
JournalSpine
Volume28
Issue number10
DOIs
StatePublished - May 15 2003

Fingerprint

Diskectomy
Radiculopathy
Laminectomy
Gels
Pain
Leg
Magnetic Resonance Imaging
Outcome Assessment (Health Care)
Ambulatory Surgical Procedures
Clinical Studies
Oxiplex
Lower Extremity
Safety
Epidural Space
Activities of Daily Living
Nervous System
Physical Examination

Keywords

  • Discectomy
  • Failed back
  • Laminectomy
  • Laminotomy
  • Oxiplex/SP Gel
  • Surgery

ASJC Scopus subject areas

  • Physiology
  • Clinical Neurology
  • Orthopedics and Sports Medicine

Cite this

Kim, K. D., Wang, J. C., Robertson, D. P., Brodke, D. S., Olson, E. M., Duberg, A. C., ... Ducker, T. B. (2003). Reduction of radiculopathy and pain with Oxiplex/SP Gel after laminectomy, laminotomy, and discectomy: A pilot clinical study. Spine, 28(10), 1080-1088. https://doi.org/10.1097/00007632-200305150-00023

Reduction of radiculopathy and pain with Oxiplex/SP Gel after laminectomy, laminotomy, and discectomy : A pilot clinical study. / Kim, Kee D; Wang, Jeffrey C.; Robertson, Daniel P.; Brodke, Darrel S.; Olson, Erik M.; Duberg, Arthur C.; BenDebba, Mohammed; Block, Kathleen M.; DiZerega, Gere S.; Ducker, Thomas B.

In: Spine, Vol. 28, No. 10, 15.05.2003, p. 1080-1088.

Research output: Contribution to journalArticle

Kim, KD, Wang, JC, Robertson, DP, Brodke, DS, Olson, EM, Duberg, AC, BenDebba, M, Block, KM, DiZerega, GS & Ducker, TB 2003, 'Reduction of radiculopathy and pain with Oxiplex/SP Gel after laminectomy, laminotomy, and discectomy: A pilot clinical study', Spine, vol. 28, no. 10, pp. 1080-1088. https://doi.org/10.1097/00007632-200305150-00023
Kim, Kee D ; Wang, Jeffrey C. ; Robertson, Daniel P. ; Brodke, Darrel S. ; Olson, Erik M. ; Duberg, Arthur C. ; BenDebba, Mohammed ; Block, Kathleen M. ; DiZerega, Gere S. ; Ducker, Thomas B. / Reduction of radiculopathy and pain with Oxiplex/SP Gel after laminectomy, laminotomy, and discectomy : A pilot clinical study. In: Spine. 2003 ; Vol. 28, No. 10. pp. 1080-1088.
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abstract = "Study Design. Safety using Oxiplex/SP Gel during single-level discectomy for reduction of symptoms associated with unilateral herniation of the lumbar disc was investigated by self-assessment questionnaire and magnetic resonance imaging. Objective. To evaluate the safety and assess the efficacy parameters of Oxiplex/SP Gel. Summary of Background Data. Animal studies demonstrated that Oxiplex/SP Gel (CMC/PEO) reduced epidural fibrosis after lumbar surgery. Methods. Surgeons examined spine and lower extremities of patients scheduled for discectomy to assess neurologic function and pain. Treated patients received sufficient Oxiplex/SP Gel (1-3 mL) to coat the nerve root and fill the epidural space. The control condition was surgery alone. At baseline, then 30 days, 90 days, and 6 months after surgery, patients completed self-assessment questionnaires concerning leg pain, lower extremity weakness, functional disability, daily living activities, symptoms, and radiculopathy. Magnetic resonance imaging was performed at baseline and 90 days after surgery. At 30 and 90 days after surgery, patients underwent physical examination, wound inspection, and laboratory tests. Results. The surgical procedures were well tolerated by the 23 patients treated with Oxiplex/SP Gel and the 11 control patients. There were no unanticipated adverse events, no clinically-significant laboratory results, and no significant differences detected by magnetic resonance imaging. Treated patients had greater reduction in outcome measures at 30 days. The differences in scores were attenuated at 90 days and 6 months. A subgroup, the patients with significant leg pain and weakness at baseline (11 patients treated with Oxiplex/SP Gel and 7 control patients), had greater reduction in outcome measures than the control patients throughout the study. Conclusions. Oxiplex/SP Gel was easy to use and safe for patients undergoing unilateral discectomy. Greater benefit in clinical outcome measures was seen in geltreated patients, especially those with severe leg pain and weakness at baseline.",
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AU - Brodke, Darrel S.

AU - Olson, Erik M.

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