Decision for reconstructive interventions of the upper extremities in tetraplegia: the effect of treatment characteristics

ISRCTN	ISRCTN93725261
DOI	https://doi.org/10.1186/ISRCTN93725261
Secondary identifying numbers	014-32-026 and 96-06-004, NL422 (NTR462)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr G Snoek
Scientific

Roessingh Research and Development B.V.
Reoessinghsbleekweg 33 B
Enschede
7522 AH
Netherlands

Phone	+31 (0)53 487 5777
Email	g.snoek@rrd.nl

Study design	Survey
Primary study design	Observational
Secondary study design	Multi-centre
Study setting(s)	Other
Study type	Other
Scientific title	Decision for reconstructive interventions of the upper extremities in tetraplegia: the effect of treatment characteristics
Study objectives	To assess the effect of treatment characteristics on the decisions made by subjects with tetraplegia concerning reconstructive interventions for the upper extremities.
Ethics approval(s)	Approval received from the Medisch Ethische Toetsingscommissie ( Medical-ethical board) of Roesingh Rehabilitation Centre on the 27th February 2002 (ref: 02.08.7.2).
Health condition(s) or problem(s) studied	Spinal cord injury
Intervention	Seven specialised spinal cord injury centres in the Netherlands. 53 individuals with tetraplegia in a stable condition were surveyed on the importance and the relative weight of seven treatment characteristics: 1. Type of intervention 2. Number of operations 3. Inpatient rehabilitation period 4. Outpatient rehabilitation period 5. Risk of complications 6. Results of elbow function 7. Results of hand function
Intervention type	Other
Primary outcome measure	Importance and the relative weight of seven treatment characteristics on the decision to undergo reconstructive surgery determined by means of Conjoint Analysis.
Secondary outcome measures	No secondary outcome measures
Overall study start date	05/09/2002
Completion date	01/02/2005

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	53
Total final enrolment	49
Key inclusion criteria	1. A motor complete C5, C6 or C7 Spinal Cord Injury (SCI), according to the guidelines of the American Spinal Injury Association (ASIA) 2. At least one arm classified as motor group one to four according to the International Classification for Surgery of the Upper Limb in Tetraplegia 3. Subjects had to be medically and neurologically stable 4. At least one year after the initial injury 5. Possible candidates for surgical reconstruction of elbow extension and palmar and/or lateral grasp function
Key exclusion criteria	1. Previously undergone surgery to improve Upper Extremity (UE) function 2. Extensively informed about these interventions 3. Declined treatment in the past five years
Date of first enrolment	05/09/2002
Date of final enrolment	01/02/2005

Roessingh Research and Development B.V.

Enschede
7522 AH
Netherlands

Roessingh Research and Development B.V. (The Netherlands)
Industry

P.O. Box 310
Enschede
7500 AH
Netherlands

Phone	+31 (0)53 487 5777
Email	info@rrd.nl
Website	http://www.rrd.nl/www/indexa.html
"ROR"	https://ror.org/01dmjt679

Research organisation

The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		07/08/2007	26/08/2021	Yes	No

26/08/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.