Results of applying ADCON-L gel after lumbar discectomy: the German ADCON-L study

Abstract

<jats:p content-type="fine-print"><jats:italic>Object.</jats:italic> Failed-back syndrome is still an unsolved problem. Use of ADCON-L gel, already commercially available, has been proven to reduce postoperative scarring in animal experiments. The authors of two controlled clinical studies have also shown positive results when applying the gel. They did not, however, establish patient-oriented endpoints. The authors report a study of ADCON-L in which they focus on patient-oriented endpoints.</jats:p> <jats:p content-type="fine-print"><jats:italic>Methods.</jats:italic> Patients with lumbar disc herniation were randomized to an ADCON-L—treated or control group. Therapeutic success was evaluated using the validated Hannover Questionnaire on Activities of Daily Living (FFbH) 6 months after surgery. The study took place between November 14, 1996, and April 20, 1998, in eight neurosurgical centers in Germany. A total of 398 patients was recruited; 41 patients dropped out during follow up.</jats:p> <jats:p content-type="fine-print">The mean functional FFbH score (100 points = all activities are possible without problem; 0 points = no activity is possible) was 78.5 points in the ADCON-L—treated group compared with 80 points in the control group. Furthermore, in terms of secondary outcome variables, the ADCON-L group did not have an advantage over the control group. Only the mean magnetic resonance imaging score showed a slight advantage of ADCON-L over the control group.</jats:p> <jats:p content-type="fine-print"><jats:italic>Conclusions.</jats:italic> The authors found no positive effect of treatment with ADCON-L gel in patients in whom one-level lumbar microdiscectomy was performed. Because of its rather large sample size and its homogeneity, the study had sufficient power to detect even small differences between the two groups.</jats:p>

Inhibition of spinal fusion by use of a tissue ingrowth inhibitor

“…The results of using the gel clinically have been positive, however, there is controversy over the patient-oriented endpoints realized. No positive effect of treatment with ADCON-L gel has been found in patients for whom one-level lumbar microdiscectomy was performed in a multicentral, randomized, controlled clinical study [19]. There have not yet been any reports of inhibition of bone formation in that connection.…”

The clinical effectiveness and cost-effectiveness of management strategies for sciatica: systematic review and economic model

“…Just over half (33/62, 53%) of the disc surgery studies were RCTs, of which only two 87,99 were good quality overall (comparing disc surgery with usual care). Four RCTs 68,73,89,99 had used both adequate randomisation and allocation concealment (comparators included exercise therapy, intraoperative interventions and usual care). A further eight studies 81,[85][86][87][88]101,106,107 used adequate randomisation, but not allocation concealment (although two studies 87,106 used sealed envelopes), and one study 69 used adequate allocation concealment, but not randomisation.…”

Prevention of epidural fibrosis in rats by local or systemic administration of citicoline

“…for preventing epidural fibrosis, however, none of them have entered clinical use (8,16,18,19,21,23,29,42,46). Therefore, new studies are required in order to discover new materials or chemicals that could prevent epidural fibrosis.…”