Clinical Experience in Spine Surgery

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Oxiplex refers to the adhesion barrier gel made by FzioMed and available under the brand names Oxiplex®, Oxiplex®/SP and MediShield™. Intended Use: As an adjunct to posterior lumbar laminectomy, laminotomy, or discectomy procedures for reducing pain, radiculopathy, lower extremity weakness, and the incidence, extent, and severity of postoperative adhesions.1,2

Significantly Less Leg & Back Pain at 6 Months Post-Surgery 3,4,5,6,7,8

Significantly Less Leg & Back Pain at 6 Months Post-Surgery 3,4,5,6,7,8

From a 352-patient US pivotal clinical study comparing lumbar surgery with Oxiplex® gel to surgery only.

Oxiplex-treated patients had 35% less leg pain and 28% less back (spine) pain at 6 months post-surgery compared to surgery-only controls (in patients with severe baseline back pain, Oxiplex n=78 vs. Controls n=78). See Clinical Study Details

  • Less residual leg and back pain
  • Fewer neurological symptoms
  • No post-op CSF leaks
  • Fewer re-operations
  • Enhanced patient satisfaction

Graph of Leg Pain

At 6 months post-surgery

Results shown are from a prospective, multi-center, randomized, blinded, parallel group 352-patient US pivotal clinical study comparing Oxiplex-treated patients (n=177) to surgery only (n=175), to assess the safety and effectiveness of Oxiplex spine gel to reduce postsurgical pain in patients undergoing their first single-level laminotomy, laminectomy, or discectomy at L4-L5 or L5-S1. Patients were randomly selected to receive surgery only or surgery plus Oxiplex gel placed on and around the dura and nerve root prior to wound closure. The effectiveness of Oxiplex for the reduction of pain and associated symptoms was assessed at baseline (before surgery) and at 1, 3 and 6 months following surgery using quality of life measure Lumbar Spine Outcomes Questionnaire (LSOQ) (Ben Debba et al ) and clinical evaluations.

Proportion of Subjects with Zero Leg Pain at Final Follow-up (ITT)

Graph of Proportion

  • In the severe baseline back pain group, 54.4% of Oxiplex subjects had no leg pain at final follow-up (6 months) vs. 47.5% of control subjects
  • Median leg pain at 6 months in Oxiplex group was zero in both the overall ITT population and for subjects with severe baseline back pain

Responder Analysis Overall Treatment Success at 6 Months

Graph of Responder Analysis

Responder Analysis Definition

  • Reduction of at least 20 points in LSOQ composite score
  • No additional procedures on lower back
  • Absence of neurological deficits

Fewer Re-Operations in Oxiplex-Treated Patients

Fewer Re-Operations in Oxiplex-Treated Patients

Patients in the Oxiplex group had fewer reoperations during the 6-month follow-up period than patients in the surgery-only Control group:

Excellent Safety

Over 400,000 patients treated.

As an adjunct to posterior lumbar laminectomy, laminotomy, or discectomy procedures for reducing pain, radiculopathy, lower extremity weakness, and the incidence, extent, and severity of postoperative adhesions.

(Not available for distribution in the United States.)

Safety Profile

Safety Profile

In the prospective, multi-center, randomized, controlled, third-party blinded 352-patient U.S. pivotal clinical trial comparing Oxiplex-treated patients (n=177) to surgery only (n=175), to assess the safety and effectiveness of Oxiplex spine gel to reduce postsurgical pain and symptoms in patients undergoing single-level laminotomy, laminectomy, or discectomy at L4-L5 or L5-S1.

In all study patients (Oxiplex N=177, Controls N=175) there were:

  • No significant difference in adverse events and serious adverse events between Oxiplex and Control groups. No adverse events led to discontinuation of any subject or discontinuation of the study.
  • No serious adverse events related to Oxiplex.
  • Fewer neurological abnormalities in Oxiplex group compared to Control group.
  • Fewer musculoskeletal abnormalities in Oxiplex group compared to Control group.
  • Fewer reoperations in Oxiplex group compared to Control group (1 vs. 6).

In independent studies, excellent safety related to the use of CMC/PEO spine gels.9, 10, 11, 12

In pre-clinical studies, reduction of epidural fibrosis was accompanied by normal bone healing and CMC/PEO gels did not inhibit dural healing.13, 14

Last updated: 19 Aug 2016

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References

1 FzioMed's products are not currently available for commercial distribution in the United States.

2 In Canada, Oxiplex is authorized for use to reduce pain and symptoms.

3 Rhyne A, et al. Oxiplex reduces leg pain, back pain, and associated symptoms after lumbar discectomy. Spine 37:631-641, 2012.

4 Blumenthal S, et al. Oxiplex reduces the incidence of back pain, leg pain and associated symptoms 6 months following single-level lower lumbar surgery for removal of herniated disc. Poster presentation, Geneva, Switzerland, SpineWeek 2008.

5 Arnold P, et al. Oxiplex gel reduces neurological sequelae following lumbar surgery. Poster 1147, Chicago, IL USA, Annual Meeting of the American Association of Neurological Surgeons (AANS) 2008.

6 Kim KD, et al. Multicenter clinical study evaluating Oxiplex in lumbar surgery. Presentation (abstract no. 73), Annual Meeting of the Congress of Neurological Surgeons (CNS) 2008.

7 Wang JC and Arnold P. Oxiplex reduces the incidence of back pain, leg pain, and associated symptoms 6 months following single level lumbar laminectomy for removal of a herniated disc. Presentation, North American Spine Association (NASS) 2008.

8 BenDebba M, diZerega GS, Long DM. The Lumbar Spine Outcomes Questionnaire: its development and psychometric properties. Spine J, 7:118-132, 2007.

9 Fransen P. Safety of carboxymethylcellulose/polyethylene oxide for the prevention of adhesions in lumbar disc herniation - consecutive case series review. Ann Sur Innov Res, 2:2, 2008.

10 Assietti R. New treatments for the reduction of leg pain and lower-extremity weakness. Euro Musc Rev, 1, March 2007.

11 Guizzardi G, et al. Use of a novel gel-formulated anti-adhesion barrier for prevention of fibrotic adhesions, in lumbar micro-discectomy procedures. Presentation, Congress of Neurological Surgeons (CNS) 2006.

12 Assietti R, et al. Use of carboxymethylcellulose/polyethylene oxide gel in microdiscectomy with interlaminectomy: A case series comparison with long-term follow-up. Spine, 33 (16): 1762-1765, 2008.

13 Rodgers, KE, et al. Reduction of epidural fibrosis in lumbar surgery with Oxiplex adhesion barriers of carboxymethylcellulose and polyethylene oxide. Spine J, 3:277-284, 2003.

14 Rodgers KE, et al. Evaluation of FzioMed adhesion barrier gel on dural healing in a model of epidural fibrosis in rabbits. Poster, Congress of Neurological Surgeons (CNS), Denver, CO USA, 2003.