|- candidate number||1396|
|- NTR Number||NTR462|
|- Date ISRCTN created||26-feb-207|
|- date ISRCTN requested||18-nov-2005|
|- Date Registered NTR||6-sep-2005|
|- Secondary IDs||nos. 014-32-026 and 96-06-004 |
|- Public Title||Decision for reconstructive interventions of the upper extremities in tetraplegia: the effect of treatment characteristics.|
|- Scientific Title||Preference for additional hand function treatment in tetraplegia.|
|- hypothesis||None; study was a survey.|
|- Healt Condition(s) or Problem(s) studied||Spinal cord injury|
|- Inclusion criteria||The inclusion criteria were a motor complete C5, C6 or C7 SCI, according to the guidelines of the American Spinal Injury Association (ASIA) , with at least one arm classified as motor group 1 to 4 according to the International Classification for Surgery of the Upper Limb in Tetraplegia. Subjects had to be medically and neurologically stable, at least one year after the initial injury, and possible candidates for surgical reconstruction of elbow extension and palmar and/or lateral grasp function.|
|- Exclusion criteria||Subjects were excluded if they had previously undergone surgery to improve UE function, or if they had been extensively informed about these interventions and had declined treatment in the past 5 years.|
|- mec approval received||yes|
|- multicenter trial||yes|
|- planned startdate ||5-sep-2002|
|- planned closingdate||1-feb-2005|
|- Target number of participants||53|
|- Primary outcome||Importance and the relative weight of 7 treatment characteristics on the decision to undergo reconstructive surgery.|
|- Secondary outcome||N/A|
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||Dr. G. Snoek|
|- CONTACT for SCIENTIFIC QUERIES||Dr. G. Snoek|
|- Sponsor/Initiator ||Roessingh Research and Development b.v.|
(Source(s) of Monetary or Material Support)
|Dutch Health Research and Development Council|
|- Publications||Spinal Cord. 2008 Mar;46(3):228-33. Epub 2007 Aug 7.|
|- Brief summary||Objective: |
To assess the effect of treatment characteristics on the decisions made by subjects with tetraplegia concerning reconstructive interventions for the upper extremities.
Seven specialized spinal cord injury centres in the Netherlands.
A sample of 49 individuals with tetraplegia in a stable condition.
Main outcome measure:
Importance and the relative weight of 7 treatment characteristics on the decision to undergo reconstructive surgery determined by means of Conjoint Analysis.
All 7 characteristics contributed to the decision to undergo surgery (p< 0.01). The relative weights were: for type of intervention 0.14 (95% confidence interval (CI) 0.05-0.23), for number of operations 0.15 (95% CI: 0.05-0.25), for inpatient rehabilitation period 0.22 (95% CI: 0.10-0.32), for outpatient rehabilitation period 0.08 (95% CI: 0.02-0.14), for risk of complications 0.16 (95% CI:0.06-0.26), for results of elbow function 0.1 (95% CI:0.02-0.18), and for results of hand function 0.15 (95% CI: 0.05-0.25). In 40.8% of the subjects one characteristic had a relative weight of 0.30 or more.
Non-health outcome factors related to the intensity of treatment are as important or even or more important than the potential outcome of hand or elbow function in the decision to undergo reconstructive therapy. Inpatient rehabilitation period was the most important factor, and a substantial number of subjects focus on only one characteristic in their decision-making process.
|- Main changes (audit trail)|
|- RECORD||6-sep-2005 - 2-jul-2008|