Results. Significant improvements were maintained throughout 6 months (24 weeks) of follow-up ( P < , respectively). The average visual analog scale (VAS) pain scores at 24 weeks improved to ± cm in the IL group and ± cm in the TF group ( P = ). Baseline functional capacity was comparable for the IL and the TF group (52% vs 53%) when assessed using Oswestry ( P = ). At 6 months, both groups improved, 39% for the IL group and 38% for the TF group, suggesting change from severe to moderate disability scoring range. There were 24 out of the 32 (75%) patients in the IL group at 24 weeks who improved more than 2 cm on the VAS scale and 17 patients (53%) had >50% of the pain relief. In the TF group, there were 27 out of the 32 (84%) patients with >2 cm improvement on VAS pain scale, and 20 of 32 (63%) with >50% improvement at 24 weeks. Functional capacity changes were similar, 16 out of the 32 patients (50%) improved 10 points or more on the Oswestry scale in the IL group and 21 out of the 32 in the TF group (66%).
As a patient, there is always potential risk in having surgery or getting a medical device. Usually these risks are rare. You should refer to the coflex® Patient Labeling ( Contact us to receive your own coflex® information brochure ) for a list of all potential risks and hazards that were observed during the clinical study. For patients receiving coflex®, the biggest risk is continued pain. Other risks include wound healing problems (such as infection or drainage), brief numbness or tingling in your arms or legs, and spinous process fractures. Some patients had illnesses or diseases not related to their surgery, like problems with their skin, problems breathing, problems with their heart, and other muscle or bone pain or soreness. In the clinical trial, similar problems were experienced with patients who had fusion. The coflex® surgery may not help relieve pain in some patients, and you may need another surgery to remove the device. It is hard to predict who will not benefit from this surgery.