Low back pain can be disabling and compromise one’s quality of life. Lumbar stenosis is one of those disabling back issues. But exactly what is lumbar stenosis? What is a Coflex Implant? How long does a Coflex Implant last? Let’s dig in.
What is Lumbar Stenosis?
Lumbar stenosis is narrowing of the central spinal canal with pressure on the spinal nerves and cord that can cause low back, leg pain and reduced level of activity. It is common with an incidence of as many as 38.8% of adults 60 years or older in the United States (1). Disc protrusions, facet joint overgrowth, thickening of the spinal ligaments and misalignment of the spine bones can cause lumbar stenosis. Patients typically reduce their pain by flexing forward at the level of the hips which is referred to as a shopping cart sign (2).
What is a Coflex Implant?
The Coflex Implant is a surgical implant designed to treat lumbar stenosis. The implant is a single piece of titanium that is inserted between the spinous processes and is reported to be flexible enough to support the spine. The spinous processes are the boney projections on the back of the spine. The Coflex implant is one of several interspinous spacers on the market and is offered as a surgical alternative to lumbar fusion. Lumbar fusion is where two or more spinal bones are bolted together with hardware. The Coflex implant limits backward bending (extension) which typically makes the symptoms of lumbar stenosis worse. Other reported benefits include less time in the operating room and hospital, quicker recovery and maintenance of a range of motion when compared to lumbar fusion. The surgery is performed in an operating room under a general anesthetic lasting approximately 1-2 hours.
How Long Does Coflex Last?
The Coflex implant itself can fail for a number of reasons which in most cases requires additional surgery and removal. Failure can occur when the implant becomes dislodged or rotated or when there is a fracture of the supporting spinal bones. A high-level study which reviewed 37 studies of patients who underwent Coflex surgery, demonstrated a device failure rate of 3.7% requiring additional surgery at 24 months (3)
How Much Does Coflex Surgery Cost?
Costs will vary significantly with the type of insurance, location of the surgery and other regional factors. In 2017 the national average medicare payment for Coflex implant was $17,253 (4). If additional surgeries are required due to failure there would be additional costs.
Are There Complications?
Like all surgical procedures there are complications associated with the Coflex implant which include:
Spine bone fracture
The Coflex implant is wedged between two spinal boney projections which are called spinous processes. These small bones can fracture during the surgery or thereafter which typically requires surgery and removal of the implant (5).
Increase in Pain
The Coflex implant is designed to reduce pain and dysfunction associated with lumbar stenosis. Unfortunately, this is not always the case and the surgery itself can result in an increase in low back pain.
Like all implants, the Coflex surgical implant can become loose and dislodge potentially creating a host of new symptoms. When this occurs additional surgery is indicated.
The Coflex implant has been associated with the formation of new large bone spurs. The spurs can narrow the spinal canal leading to the recurrence of lumbar stenosis symptoms. In one study, the incidence of bone spur formation was 81% at 24-57 month follow up (6).
The Coflex implant is sandwiched between two spinal bones called the spinous process. These bones are susceptible to injury and erosion as a result of the implant which requires surgery and removal. A recent study found bone erosion in 14 of 30 Coflex patients (7).
Adjacent Segment Disease
Adjacent segment disease is common in patients that undergo lumbar fusion surgery. The lumbar disc is designed to absorb the forces of daily living. When one or more the discs are fused, the forces of daily living are then transferred to the disc and facets above and below the level of the fusion. These additional forces cause injury and degeneration. Patients who underwent Coflex surgery were noted to have adjacent segment disease 3 years after surgery (8).
To learn more about adjacent segment disease please click on the video below.
Nonsurgical Treatment Options
Centeno-Schultz Clinic has extensive experience in the treatment of lumbar stenosis with both PRP and stem cells. PRP has been demonstrated to be effective in the treatment of lumbar injuries (9). The Regenexx Percutaneous Flavoplasty is an effective nonsurgical treatment that addresses the structural issues that can cause lumbar stenosis. Under precise ultrasound guidance, PRP is injected into the loose spinal ligaments to tighten them and reduce instability. The facet joints are injected to reduce swelling. The swollen spinal nerves are injected under x-ray guidance to reduce pain and increase function. The weakened spinal muscles called multifidus are also injected with growth factors to promote strengthening.
To learn more about lumbar stenosis and nonsurgical treatment options please click the video below.
The Coflex is a single-piece titanium surgical implant used in the treatment of lumbar stenosis. The implant is inserted between two spinous processes and reduces backward bending and thought to improve stability. Complications can occur and include spinal bone fracture, escalation in pain, the formation of bone spurs, bone erosion, adjacent segment disease, and failure after becoming dislodged. PRP injected precisely into the spinal facet joints, ligaments, muscles and around the disc is an effective nonsurgical option without the risks of traditional surgery.
- Kalichman L, Cole R, Kim DH, et al. Spinal stenosis prevalence and association with symptoms: the Framingham Study. Spine J. 2009;9(7):545-50.DOI: 10.1016/j.spinee.2009.03.005
- Ammendolia C. Degenerative lumbar spinal stenosis and its imposters: three case studies. J Can Chiropr Assoc. 2014;58(3):312-9.
- Parker SL, Anderson LH, Nelson T, Patel VV. Cost-effectiveness of three treatment strategies for lumbar spinal stenosis: Conservative care, laminectomy, and the Superion interspinous spacer. Int J Spine Surg. 2015;9:28. DOI:10.14444/2028
- Zang L, DU P, Hai Y, Su QJ, Lu SB, Liu T. Device related complications of the Coflex interspinous process implant for the lumbar spine. Chin Med J. 2013;126(13):2517-22.
- Tian NF, Wu AM, Wu LJ, et al. Incidence of heterotopic ossification after implantation of interspinous process devices. Neurosurg Focus. 2013;35(2):E3.DOI: 10.3171/2013.3.FOCUS12406
- Lee N, Shin DA, Kim KN, et al. Paradoxical Radiographic Changes of Coflex Interspinous Device with Minimum 2-Year Follow-Up in Lumbar Spinal Stenosis. World Neurosurg. 2016;85:177-84.DOI: 10.1016/j.wneu.2015.08.069
- Dong Y, Zheng X, Gu H, Liang G, Zhuang J, et al. (2018) Is the Interspinous Device (Coflex) Outdated in the Treatment of Lumbar Spinal Stenosis? A Seven-Year Follow-up. Spine Res. Vol.4 No.1:2 DOI: 10.21767/2471-8173.100042. doi: 10.21037/jss.2016.01.07
- Mohammed S, Yu J. Platelet-rich plasma injections: an emerging therapy for chronic discogenic low back pain. J Spine Surg. 2018;4(1):115-22. doi: 10.21037/jss.2018.03.04