Advertisement

Condoliase therapy for lumbar disc herniation -2 year clinical outcome-

Published:November 21, 2022DOI:https://doi.org/10.1016/j.jos.2022.11.005

      Abstract

      Background

      Condoliase-induced chemonucleolysis is a less invasive treatment for lumbar disc herniation (LDH); however, its long-term clinical outcomes remain unclear. We investigated 2-year clinical outcomes and assess radiographs after chemonucleolysis with condoliase.

      Methods

      We enrolled patients with LDH who received condoliase therapy, with a minimum follow-up period of two years. Sixty-seven patients (44 men, 23 women; mean age, 46.7 ± 18.0 years) were analyzed. Time-course changes in disc height, disc degeneration, and herniation size were assessed. For clinical outcomes assessment, visual analog scale (VAS) scores for leg and back pain and the Oswestry disability index (ODI) were obtained at baseline and the 3-month, 1-year, and 2-year follow-ups. We obtained a questionnaire from these patients at two years to assess satisfaction and recommendation. Condoliase therapy was considered to be effective in patients whose VAS score for leg pain improved by ≥ 50% at 2 years from baseline and who did not require surgery.

      Results

      Condoliase therapy was effective in 51 patients (76.1%). Eight patients (11.9%) required surgery due to ineffectiveness of the therapy. Condoliase therapy was ineffective in five out of six patients with a history of discectomy. The ODI and VAS scores for leg and back pain significantly improved from three months to two years. Of the patients, 80% satisfied with their outcomes, and 85% recommended this therapy. Progression of disc degeneration was observed in 57.1% of patients at three months; however, 30% recovered to baseline at two years. The mean disc height decreased at three months, but recovered slightly at one year and remained stable until two years. No recurrent disc herniation was observed.

      Conclusions

      Chemonucleolysis with condoliase was effective in 78% of patients with LDH for 2 years. Chemonucleolysis-induced disc degeneration was slightly recovered and maintained for two years post-injection. This treatment resulted in high patient satisfaction and recommendations.

      Keywords

      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribe:

      Subscribe to Journal of Orthopaedic Science
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

        • Peul W.C.
        • van Houwelingen H.C.
        • van den Hout W.B.
        • Brand R.
        • Eekhof J.A.
        • Tans J.T.
        • et al.
        Surgery versus prolonged conservative treatment for sciatica.
        N Engl J Med. 2007 May 31; 356: 2245-2256
        • Atlas S.J.
        • Keller R.B.
        • Wu Y.A.
        • Deyo R.A.
        • Singer D.E.
        Long-term outcomes of surgical and nonsurgical management of sciatica secondary to a lumbar disc herniation: 10 year results from the Maine lumbar spine study.
        Spine (Phila Pa 1976). 2005 Apr 15; 30: 927-935
        • Fjeld O.R.
        • Grovle L.
        • Helgeland J.
        • Smastuen M.C.
        • Solberg T.K.
        • Zwart J.A.
        • et al.
        Complications, reoperations, readmissions, and length of hospital stay in 34 639 surgical cases of lumbar disc herniation.
        Bone Joint Lett J. 2019 Apr; 101-b: 470-477
        • Simmons J.W.
        • Nordby E.J.
        • Hadjipavlou A.G.
        Chemonucleolysis: the state of the art.
        Eur Spine J. 2001 Jun; 10: 192-202
        • Smith L.
        Enzyme dissolution of the nucleus pulposus in humans.
        JAMA. 1964 Jan 11; 187: 137-140
        • Shields C.B.
        • Reiss S.J.
        • Garretson H.D.
        Chemonucleolysis with chymopapain: results in 150 patients.
        J Neurosurg. 1987 Aug; 67: 187-191
        • Wardlaw D.
        Sciatica caused by disc herniation: why is Chymopapain Chemonucleolysis denied to our patients?.
        Internet J Spine Surg. 2016; 10: 44
        • Yamagata T.
        • Saito H.
        • Habuchi O.
        • Suzuki S.
        Purification and properties of bacterial chondroitinases and chondrosulfatases.
        J Biol Chem. 1968 Apr 10; 243: 1523-1535
        • Hamai A.
        • Hashimoto N.
        • Mochizuki H.
        • Kato F.
        • Makiguchi Y.
        • Horie K.
        • et al.
        Two distinct chondroitin sulfate ABC lyases. An endoeliminase yielding tetrasaccharides and an exoeliminase preferentially acting on oligosaccharides.
        J Biol Chem. 1997 Apr 4; 272: 9123-9130
        • Kato F.
        • Mimatsu K.
        • Iwata H.
        • Miura T.
        Comparison of tissue reaction with chondroitinase ABC and chymopapain in rabbits as the basis of clinical application in chemonucleolysis.
        Clin Orthop Relat Res. 1993 Mar; 288: 294-302
        • Olmarker K.
        • Danielsen N.
        • Nordborg C.
        • Rydevik B.
        Effects of chondroitinase ABC on intrathecal and peripheral nerve tissue. An in vivo experimental study on rabbits.
        Spine (Phila Pa 1976). 1991 Jan; 16: 43-45
        • Olmarker K.
        • Stromberg J.
        • Blomquist J.
        • Zachrisson P.
        • Nannmark U.
        • Nordborg C.
        • et al.
        Chondroitinase ABC (pharmaceutical grade) for chemonucleolysis. Functional and structural evaluation after local application on intraspinal nerve structures and blood vessels.
        Spine (Phila Pa 1976). 1996 Sep 1; 21: 1952-1956
        • Chiba K.
        • Matsuyama Y.
        • Seo T.
        • Toyama Y.
        Condoliase for the treatment of lumbar disc herniation: a randomized controlled trial.
        Spine (Phila Pa 1976). 2018 Aug 1; 43 (e76): E869
        • Matsuyama Y.
        • Chiba K.
        • Iwata H.
        • Seo T.
        • Toyama Y.
        A multicenter, randomized, double-blind, dose-finding study of condoliase in patients with lumbar disc herniation.
        J Neurosurg Spine. 2018 May; 28: 499-511
        • Banno T.
        • Hasegawa T.
        • Yamato Y.
        • Yoshida G.
        • Yasuda T.
        • Arima H.
        • et al.
        Clinical outcome of condoliase injection treatment for lumbar disc herniation: indications for condoliase therapy.
        J Orthop Sci. 2021 Jan; 26: 79-85
        • Banno T.
        • Hasegawa T.
        • Yamato Y.
        • Yoshida G.
        • Arima H.
        • Oe S.
        • et al.
        Disc degeneration could be recovered after chemonucleolysis with condoliase.-1 year clinical outcome of condoliase therapy.
        J Orthop Sci. 2022 Jul; 27: 767-773
        • Okada E.
        • Suzuki S.
        • Nori S.
        • Tsuji O.
        • Nagoshi N.
        • Yagi M.
        • et al.
        The effectiveness of chemonucleolysis with condoliase for treatment of painful lumbar disc herniation.
        J Orthop Sci. 2021 Jul; 26: 548-554
        • Inoue M.
        • Sainoh T.
        • Kojima A.
        • Yamagata M.
        • Morinaga T.
        • Mannoji C.
        • et al.
        Efficacy and safety of condoliase disc administration as a new treatment for lumbar disc herniation.
        Spine Surg Relat Res. 2022; 6: 31-37
        • Ishibashi K.
        • Fujita M.
        • Takano Y.
        • Iwai H.
        • Inanami H.
        • Koga H.
        Chemonucleolysis with chondroitin sulfate ABC endolyase for treating lumbar disc herniation: exploration of prognostic factors for good or poor clinical outcomes.
        Medicina (Kaunas). 2020 Nov 19; 56
        • Nakajima H.
        • Kubota A.
        • Maezawa Y.
        • Watanabe S.
        • Honjoh K.
        • Ohmori H.
        • et al.
        Short-term outcome and predictors of therapeutic effects of intradiscal condoliase injection for patients with lumbar disc herniation.
        Spine Surg Relat Res. 2021; 5: 264-271
        • Modic M.T.
        • Steinberg P.M.
        • Ross J.S.
        • Masaryk T.J.
        • Carter J.R.
        Degenerative disk disease: assessment of changes in vertebral body marrow with MR imaging.
        Radiology. 1988 Jan; 166: 193-199
        • Pfirrmann C.W.A.
        • Metzdorf A.
        • Zanetti M.
        • Hodler J.
        • Boos N.
        Magnetic resonance classification of lumbar intervertebral disc degeneration.
        Spine (Phila Pa 1976). 2001; 26: 1873-1878
        • Wardlaw D.
        • Rithchie I.K.
        • Sabboubeh A.F.
        • Vavdha M.
        • Downing M.
        • Eastmond C.J.
        Prospective randomized trial of chemonucleolysis compared with surgery for soft disc herniation with 1-year, intermediate, and long-term outcome: part II: the radiological outcome.
        Spine (Phila Pa 1976). 2013 Aug 1; 38: E1058-E1064
        • Sugimura T.
        • Kato F.
        • Mimatsu K.
        • Takenaka O.
        • Iwata H.
        Experimental chemonucleolysis with chondroitinase ABC in monkeys.
        Spine (Phila Pa 1976). 1996 Jan 15; 21: 161-165
        • Kato F.
        • Iwata H.
        • Mimatsu K.
        • Miura T.
        Experimental chemonucleolysis with chondroitinase ABC.
        Clin Orthop Relat Res. 1990 Apr; 253: 301-308
        • Carragee E.J.
        • Han M.Y.
        • Suen P.W.
        • Kim D.
        Clinical outcomes after lumbar discectomy for sciatica: the effects of fragment type and anular competence.
        J Bone Joint Surg Am. 2003 Jan; 85: 102-108
        • Swartz K.R.
        • Trost G.R.
        Recurrent lumbar disc herniation.
        Neurosurg Focus. 2003 Sep 15; 15: E10
        • Leven D.
        • Passias P.G.
        • Errico T.J.
        • Lafage V.
        • Bianco K.
        • Lee A.
        • et al.
        Risk factors for reoperation in patients treated surgically for intervertebral disc herniation: a subanalysis of eight-year sport data.
        J Bone Joint Surg Am. 2015 Aug 19; 97: 1316-1325
        • Weinstein J.N.
        • Tosteson T.D.
        • Lurie J.D.
        • Tosteson A.N.
        • Hanscom B.
        • Skinner J.S.
        • et al.
        Surgical vs nonoperative treatment for lumbar disk herniation: the Spine Patient Outcomes Research Trial (SPORT): a randomized trial.
        JAMA. 2006 Nov 22; 296: 2441-2450
        • Hansson E.
        • Hansson T.
        The cost-utility of lumbar disc herniation surgery.
        Eur Spine J. 2007 Mar; 16: 329-337
        • Koenig L.
        • Dall T.M.
        • Gu Q.
        • Saavoss J.
        • Schafer M.F.
        How does accounting for worker productivity affect the measured cost-effectiveness of lumbar discectomy?.
        Clin Orthop Relat Res. 2014 Apr; 472: 1069-1079