Bioabsorbable cervical spacers, BMP safety: 5 key findings

Written by Laura Dyrda | August 13, 2014 | Print  |

A study conducted at Georgia Spine and Neurosurgery Center and published in the International Journal of Spine Surgery examines the safety and efficacy of bioabsorbable cervical spacers with low-dose rhBMP-2 in multilevel anterior cervical discectomy and fusion.

The study included 72 consecutive patients who underwent multilevel ACDF using bioabsorbable cervical spacers and between 0.5 mg to 0.7 mg of rhBMP-2 per level. There were 187 levels treated and average follow-up was 13.8 months. The patients were around 55 years old and 16.7 percent had undergone a previous cervical procedure.

 

Here are five things to know about the results:

 

1. Average time in the operating room was 144 minutes. Estimated blood loss was 49 mL and the average length of stay at the hospital was 1.1 days. There were 21 patients — or 29 percent of the patients — who reported prolonged dysphasia beyond the two-week postoperative visit, but symptoms were resolved within four weeks for 10 patients and three months for the remaining patients.

 

2. There were major complications in 7 percent of the patients and two returned to the operating room. There was one recurrent laryngeal nerve injury and two hospital readmissions for excessive pre-vertebral swelling/dysphasia that were treated with steroids and observation.

 

3. The procedure exacerbated pre-existing medical conditions for two patients and minor complications occurred in 4 percent of the patients. In this group there was one hospital readmission for nausea/headache from narcotics.

 

4. The average NDI score improved 43 percent, lowering to 25 percent overall. The VAS neck pain improved 60 percent, going from 5.5 to 2.2, and VAS arm pain improved 52 percent to 2.6. There was also improvement in SF-36 PCS from 37.5 to 46.3 and MCS improved 18 percent from 43.2 to 50.9.

 

5. There was a high rate of patient satisfaction; 97 percent of patients said they were satisfied with the surgical outcome and 90 percent reported they would undergo the procedure again. Fusion rate was 98.6 percent in the study.

 

"Patients in this series experienced significant clinical improvements, low complication rates and high patient satisfaction," concluded the study authors. "Symptomatic pseudoarthrosis was rare. BCS filled with low-dose rhBMP-2 appears to be a safe and effective option in multilevel ACDF."

 

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