Percutaneous Disc Decompression

Questions & Answers

Q: What type of pain can be treated?
A: Low back and leg pain due to contained disc herniations.

Q: How does the procedure work?
A: The lumbar discectomy probe removes disc tissue, which may relieve painful pressure on the surrounding nerves.

Q: Will the procedure hurt?
A: There should be no pain generated by the lumbar discectomy probe. This advancement in technology requires only a tiny puncture in the skin, similar to a simple injection.

Q: How long does the procedure take?
A: The total procedure time is generally 15 minutes to 1 hour.

Q: What physician training is required to perform this procedure?
A: Board certification in a specialty such as interventional pain management, orthopedic surgery, neurosurgery, or physiatry is typical. Physicians should be experienced with discography.

Q: Can my pain be cured?
A: In some cases, pain may be eliminated. In most cases, percutaneous discectomy followed by appropriate follow up care will reduce pain to a tolerable level.

Who Is Eligible for this Procedure?
Patients exhibiting a contained, lumbar, herniated disc with low back and leg (radicular) pain that have failed conservative treatments are candidates for Percutaneous Discectomy.

Indications
The 1.5 mm Percutaneous Lumbar Discectomy Probe is intended for use in aspiration of disc material during percutaneous lumbar discectomies. Closely follow all instructions for use.

Contraindications
Traumatic spinal fracture, infection, tumor, pregnancy, and severe co-existing medical disease are contraindications.

The probe is not appropriate for treating patients with pain originating from structures other than herniated discs. Patients with free fragments, severe bony stenosis, or severely degenerative discs should be excluded.

Patients with severe and rapidly progressing neurological deficits should be excluded.

The procedure should be performed under local anesthesia or conscious sedation to allow patient monitoring for signs of segmental spinal nerve irritation. General anesthesia is contraindicated.

Potential Complications
Potential complications include: infection, bleeding, nerve damage, worse pain, failure of technique, paralysis, idiosyncratic reaction, anaphylaxis, and death.

Discectomy of the intervertebral disc nucleus pulposus for relief of low back pain and radicular pain due to contained disc herniations is the most commonly performed neurosurgical procedure, achieving success rates in excess of 90%.

Benefits of the procedure include:

A reduction in the production of perineural scarring and post-operative fibrosis

A reduction in permanent structural alterations including those produced by:

Invasion of the spinal canal

Dissection of the ligamentum flavum

Removal of lamina

Disruption of the disc annulus

Other benefits include a decrease in:

Anesthesia

Procedure time

Recovery time

Complication and morbidity rates

Postoperative spinal instability

Percutaneous Discectomy is an option for patients suffering from low back and leg (radicular) pain due to contained disc herniations that have failed conservative treatments and are interested in trying minimally invasive options prior to having traditional surgery. It can be performed under direct vision in a similar fashion to microdiscectomy or it may be performed entirely under x-ray (fluoroscopy), which reduces the entry site size to that of a standard injection (less than 1/16î needle prick, about the size of a small freckle). By comparison, standard open discectomy can involve incisions of 1î and greater.

The procedure is done with local anesthetic at the introduction site. Light conscious sedation may be used, as necessary, to help calm the patient. General anesthesia is not required (contraindicated). The total required procedure time may vary between 15 minutes and 1 hour. Total operation time should range from 1 to 10 minutes. There should be no pain generated by the operation of the device. The cannula may be slightly curved to help facilitate access to difficult anatomy including the L5/S1 disc.

Clinical Literature Summary
Percutaneous Lumbar Discectomy

Back pain is reported to affect up to 65 million Americans and is the number one reason for healthcare expenditures. 20% of the U.S. working population experiences back pain every year. By the age of 50, 97% of people have degenerated lumbar discs. Lumbar Discectomy (removal of the intervertebral disc nucleus to relieve back and leg pain) is the most commonly performed neurosurgical procedure with open surgical discectomy having been successfully performed for over fifty years [1]. The Stryker DEKOMPRESSORô Percutaneous Lumbar Discectomy Probe is a novel device that has been developed to perform Percutaneous Lumbar Discectomy (PLD) in a far less invasive manner than has previously been available.

Percutaneous discectomy is associated with reductions in complications and recovery times associated with open disc surgery. Hijikata is generally recognized as being the first to develop and report on instrumentation for percutaneous debulking of the nucleus pulposus [2]. His report on one patient experience in 1975, where the technique was proposed, was followed 13 years later by the publication of results in 136 patients [3]. Excellent or good clinical results were reported in 72% of cases with a low morbidity rate comprised of one postoperative spondylodiscitis and one vascular injury. This morbidity rate compared favorably with that of standard non-percutaneous discectomy techniques (with and without microscope), which have been reported to range as high as 11% [4] to 14% [5].

Onik and co-workers published a case report in 1985 on the first percutaneous aspiration of a herniated lumbar disc using an automated instrument [6]. This was followed in 1987 with the publication of results using this device for PLD in 36 patients [7]. Successful results were seen in 31 of the 36 patients (86%) with no significant complications observed secondary to the percutaneous discectomy. In 1989, Davis and Onik [8] published a prospective evaluation on 200 consecutive patients treated with PLD. An overall success rate of 77.5% at 6 months follow-up was reported with no occurrences of intraoperative or postoperative complications. Onik and co-investigators published a prospective, multi-institutional study in 1990 [9] where results were presented for 327 patients undergoing PLD performed by 18 surgeons in 17 centers. Of the 327 patients who prospectively met the study criteria and were followed for more than 1 year, 75.2% were successfully treated. Only one case of discitis was reported with no other serious complications noted. In particular, no vascular or nerve damage was encountered.

A significant number of other clinical investigators have now reported on their experiences with mechanical PLD. In a 1989 article in Clinical Orthopaedics and Related Research, Maroon, et al, reported on 481 patients treated with automated percutaneous lumbar discectomy probes [10]. Clinical success with the procedure was reported to rely heavily upon a learning curve in patient selection, ranging from 55% with a widened patient selection criteria, to 80% when a more limited acceptance criterion was applied later in the series. Importantly, only 2 patients (0.4%) suffered discitis infections that were successfully treated with antibiotics, one case of soft-tissue hematoma was noted, and there was no instance of great vessel or nerve damage associated with the procedure.

Gill and Blumenthal published in 1991 [11] on their experience with use of PLD in 62 patients. No neurologic injuries or major blood vessel injuries were observed. This was followed in a report by these same authors in 1993 [12] where the series was expanded to include 109 patients. There were no occurrences of neurologic or major blood vessel injuries. One patient experienced a psoas hematoma, which resolved after 10 days and one patient developed a dural leak, which spontaneously resolved with bed rest.

In 1992, Castro, et al, [13] reported on a 97 patient study of PLD where zero complications were reported for the total group. Seibel, et al, [5] published results of PLD on 110 patients where 82% of this cohort had complete remission of their neurological symptoms with no serious complications in the entire group. In particular, there were no injuries to vital structures (nerves, thecal sac, arteries, veins).

In a limited study of 21 patients published by Yeo and Tay [14] in 1993 on PLD in the Singapore Medical Journal, no patients treated had any complications or were made worse by the procedure. More recently, in 1997, Mathews, et al, [15] published the results of a prospective study of PLD in 45 patients following a defined protocol of physical and diagnostic evaluation. Of these patients, 82.2% had an excellent, very good, or good result. No patient was found to have suffered infection, bleeding, or neurovascular compromise during the 6+ month postoperative period. Most recently, both Chiu [16] and Choy [17] have reported success rates in excess of 80% when using a laser to perform PLD with no appreciable complications.

Percutaneous discectomy has been performed successfully for over 25 years. Over this time period, new arthroscopic/percutaneous techniques utilizing devices for both manual and automated removal of nucleus pulposus have been developed. In particular, Percutaneous Lumbar Discectomy (PLD) using both purely mechanical and laser based instrumentation has been introduced into the clinical setting. Benefits resulting from the use of Percutaneous Discectomy have been reported to include; good to excellent success rates, reduced procedural trauma, low outpatient treatment costs, a rapid rehabilitation process, and low morbidity.

The procedure represents a breakthrough in patient treatment due to the minimally invasive and efficient manner in which it accomplishes removal of the intervertebral disc nucleus.

Bibliography

Kambin, P. and J.L. Schaffer, Percutaneous lumbar discectomy. Review of 100 patients and current practice. Clin Orthop, 1989(238): p. 24-34.

Mayer, H.M., Spine update. Percutaneous lumbar disc surgery. Spine, 1994. 19(23): p. 2719-23.

Hijikata, S., Percutaneous nucleotomy. A new concept technique and 12 years' experience. Clin Orthop, 1989(238): p. 9-23.

Pappas, C.T., T. Harrington, and V.K. Sonntag, Outcome analysis in 654 surgically treated lumbar disc herniations. Neurosurgery, 1992. 30(6): p. 86
2-6.

Seibel, R.M., D.H. Gronemeyer, and R.A. Sorensen, Percutaneous nucleotomy with CT and fluoroscopic guidance. J Vasc Interv Radiol, 1992. 3(3): p. 571-6.

Onik, G., et al., Percutaneous lumbar diskectomy using a new aspiration probe. ANJR, 1985. 6: p. 290-3.

Onik, G., et al., Automated percutaneous diskectomy: initial patient experience. Work in progress. Radiology, 1987. 162(1 Pt 1): p. 129-32.

Davis, G.W. and G. Onik, Clinical experience with automated percutaneous lumbar discectomy. Clin Orthop, 1989(238): p. 98-103.

Onik, G., et al., Automated percutaneous discectomy: a prospective multi-institutional study. Neurosurgery, 1990. 26(2): p. 228-32; discussion 232-3.

Maroon, J.C., G. Onik, and L. Sternau, Percutaneous automated discectomy. A new approach to lumbar surgery. Clin Orthop, 1989(238): p. 64-70.

Gill, K. and S.L. Blumenthal, Clinical experience with automated percutaneous discectomy: the Nucleotome system. Orthopedics, 1991. 14(7): p. 757-60.

Gill, K. and S.L. Blumenthal, Automated percutaneous discectomy. Long-term clinical experience with the Nucleotome system. Acta Orthop Scand Suppl, 1993. 251: p. 30-3.

Castro, W.H., et al., Restriction of indication for automated percutaneous lumbar discectomy based on computed tomographic discography. Spine, 1992. 17(10): p. 1239-43.

Yeo, S.J. and B.K. Tay, Clinical experience with automated percutaneous discectomy. Singapore Med J, 1993. 34(4): p. 313-5.

Mathews, R., G. Kent, and M. Miller, APLD: A Prospective Study In An Outpatient Surgical Setting. ISIS Newsletter, 1997.

Chiu, J., et al., Microdecompressive Percutaneous Endoscopic: Spinal Discectomy with New Laser Thermodiskoplasty for Non-Extruded Herniated Nucleus Pulposus-400 cases. 1998.

Choy, D.S. and J. Ngeow, Percutaneous laser disc decompression in spinal stenosis. J Clin Laser Med Surg, 1998. 16(2): p. 123-5.