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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

Wardlaw, Douglas, MB ChB, ChM, BSc, FRCSEd*; Rithchie, Ian K., MB ChB, FRCSEd, FRCSEd(Orth); Sabboubeh, Adel F., MB ChB, MCh(Orth), FRCSEd; Vavdha, Mukta, MD§; Downing, Martin, BSc; Eastmond, Clifford J., MD, FRCP, FRCPE

doi: 10.1097/BRS.0b013e3182996301
Randomized Trial

Study Design. A prospective consecutive series of 100 patients computer randomized into 2 groups to have treatment by either chemonucleolysis or surgery.

Objective. To compare the radiological findings preoperatively with the clinical outcome between the groups at 1 year, 10 to 13, and 24 to 27 years of follow-up.

Summary of Background Data. Chemonucleolysis was introduced in 1964 and became widely used. Its efficacy was proven by several randomized studies when compared with a placebo and surgery. However, it ceased to be manufactured in 2001.

Methods. One hundred consecutive patients were enrolled for the study and randomized according to age, sex, and disc level. Preoperatively, their anteroposterior, lateral lumbar spine, and lateral lumbosacral angle radiographs were obtained, and a myelogram was performed. At 10 to 13 years, 32 of the original patients (18 chemonucleolysis and 14 surgery) and at 24 to 27 years, 45 patients (24 chemonucleolysis and 21 surgery) were assessed by lateral lumbosacral angle radiographs.

Results. Using the myelographical findings, small, medium, and large herniations were digested by chymopapain with more of the failures being the larger ones. There was an equal degree of degenerative change as measured by disc height loss in the young and older age groups and the degree of degenerative change did not relate to outcome. The size of the defect did not relate to the degree of disc height loss. There was a slight loss of disc height over time in both groups. There was no difference in the loss of disc height between the treatments at any of the follow-up time points.

Conclusion. Chemonucleolysis is as effective as surgery when assessed according to intention-to-treat analysis. The loss of disc height over time is the same in both groups. The authors think that restoration of its availability would be beneficial to patients.

Level of Evidence: 1

Chemonucleolysis, a proven treatment for disc herniation ceased manufacture in 2001. This randomized study in 100 patients showed no difference in radiological out come compared with surgery up to a mean of 25.5 years. The authors think that restoration of its availability would benefit patients experiencing disc herniation

*Department of Orthopaedics, Grampian University Hospitals NHS Trust, Woodend Hospital, Aberdeen, Scotland, United Kingdom

Department of Trauma and Orthopaedic Surgery, Forth Valley Royal Hospital, Falkirk, Stirlingshire, United Kingdom

Doncaster and Bassetlaw Hospitals NHS Trust, Doncaster Royal Infirmary, Doncaster, United Kingdom

§Department of Orthopaedics, Blackpool Royal Hospitals NHS Trust, Blackpool, United Kingdom; and

Albyn Hospital, Albyn Place, Aberdeen, Scotland, United Kingdom.

Address correspondence and reprint requests to Douglas Wardlaw, MB, ChB, ChM, FRCSEd, Mill of Monquich Farmhouse, Netherley, Stonehaven, United Kingdom, AB39 3QR; E-mail:

Acknowledgment date: October 22, 2012. First revision date: December 23, 2012. Second revision date: April 16, 2013. Acceptance date: April 23, 2013.

The device(s)/drug(s) that is/are the subject of this manuscript is/are not FDA-approved for this indication and is/are not commercially available in the United States.

No funds were received in support of this work.

Relevant financial activities outside the submitted work: consultancy.

© 2013 by Lippincott Williams & Wilkins