A randomised controlled trial comparing autologous cranioplasty with custom-made titanium cranioplasty

Acta Neurochirurgica (2018) 160:885–891

Objective To compare the long-term outcomes of patients who had been randomly allocated to receive primary titanium cranioplasty or autologous bone graft following decompressive craniectomy.

Methods Sixty-four patients had been previously enrolled and randomised to receive either their own bone graft or a primary titanium cranioplasty. Functional and cosmetic outcomes had previously been assessed at 1-year following the cranioplasty procedure. Hospital records and the Picture Archiving communication system were reviewed to determine how many patients had cranioplasty failure or associated complications such as seizures beyond 1 year—with a minimum of 24-month follow-up.

Results Amongst the 31 patients in the titanium group (one patient had died), no patients had a partial or complete cranioplasty failure at 12 months follow-up and there had been no failures beyond 12 months. Amongst the 31 patients who had an autologous cranioplasty (one patient had died), 7 patients had complete resorption of the autologous bone such that it was adjudged a complete failure at 12-month follow-up. Five of these patients had had titanium augmentation and two patients declined further surgery. Both of these patients requested cranial augmentation for functional and cosmetic reasons subsequent to the 12-month follow-up. Another patient who had previously been noted to have moderate resorption at 12 months presented 1 year later with progressive bone flap resorption and also required subsequent augmentation for functional and cosmetic reasons. When follow-up was extended to a minimum of 24 months, use of titanium instead of autologous bone for primary cranioplasty resulted in a significant reduction in the number of patients who required rescue cranioplasty (0 vs 25%, 95% confidence interval [CI] 9.1–42.1%; p = 0.001). In addition, there were significantly less total hospital healthcare costs in those patients randomised to the titanium arm of the trial (difference = A$9999, 95%CI 2231–17,768; p = 0.015).

Conclusions Bone resorption continued to occur beyond 12 months after autologous cranioplasty; use of primary titanium cranioplasty after decompressive craniectomy reduced the number of reoperations needed and the associated long-term total hospital costs.

Early Rehabilitation Targeting Cognition, Behavior, and Motor Function After Lumbar Fusion A Randomized Controlled Trial

Spine 2010;35:848–857

Study Design. Open label randomized controlled trial with 3-, 6-, 12-month, and 2- to 3-year follow-up.

Objective. To investigate the effectiveness of a psychomotor therapy focusing on cognition, behavior, and motor relearning compared with exercise therapy applied during the first 3 months after lumbar fusion.

Summary of Background Data. Postoperative management after lumbar fusion commonly focuses on analgesic pain control and activities of daily living. After 3 months, exercise therapy is often implemented. No randomized controlled trial has investigated early rehabilitation techniques conducted during the first 3 months after surgery.

Methods. The study recruited 107 patients, aged 18 to 65 years, selected for lumbar fusion because of 12 months of symptomatic spinal stenosis, spondylosis, degenerative/isthmic spondylolisthesis, or degenerative disc disease. The exercise therapy group received a home program focusing on pain contingent training of back, abdominal, and leg muscle functional strength and endurance, stretching, and cardiovascular fitness. The psychomotor therapy group received a home program and 3 outpatient sessions focusing on modifying maladaptive pain cognitions, behaviors, and motor control. Rated questionnaires investigating functional disability, pain, health-related quality of life, functional self-efficacy, outcome expectancy, fear of movement/(re)injury, and coping were assessed at 3, 6, 12 months, and 2 to 3 years after surgery.

Results. Follow-up rates were 93% at 12 months and 81% at 2 to 3 years after surgery. Psychomotor therapy improved functional disability, self-efficacy, outcome expectancy, and fear of movement/(re)injury significantly more than exercise therapy at respective follow-up occasions. Similar results occurred for pain coping but group differences were nonsignificant at 2 to 3 years follow-up. Potentially clinical relevant higher reoperation rates occurred after psychomotor therapy but rates were within normal ranges.

Conclusion. The study shows that postoperative rehabilitation can be safely implemented during the first 3 months after lumbar fusion and should include measures to modify psychological as well as motor functions.