Selective Dorsal Rhizotomy (SDR) Database

NCT02904694 | Completed DMC

• 1 other identifier: 162253
• Study Type: observational
• Target: 137
• Locations: 0 countries
• Sites: N/A

Brief Summary

A national database is being set-up to collate clinical outcome information before and after children undergo Selective Dorsal Rhizotomy (SDR). SDR is a surgical procedure that has been used for many years but has not been routinely available within the United Kingdom National Health Service (NHS). The SDR procedure is used to improve spasticity in children with cerebral palsy and involves dividing some of the nerve fibres running from the muscles back to the spinal cord. While it is believed that SDR is effective, there are no definitive data. In July 2014 NHS England commissioned five NHS Trusts to undertake SDR surgery in eligible children for a two-year period, and to collect detailed information on their outcomes. The proposed database will aggregate these data from the five centres and analyse them to provide overall evidence on the clinical effectiveness of SDR. This information will be used to inform future commissioning decisions. The database has been developed by the King's Technology Evaluation Centre (KiTEC) in conjunction with NHS England and the national clinical SDR steering committee and its data subcommittee. KiTEC undertakes research evaluations for the National Institute for Health and Care Excellence (NICE), and has been commissioned by NICE to undertake this work. Clinicians in the SDR data subgroup have liaised closely with KiTEC to agree which data to collect so that it the least amount needed and will be in a standardised format across all centres. When all two-year outcome data are recorded, KiTEC will analyse the data and present a report to NHS England, NICE and the SDR steering committee and data sub-group. While there are no firm plans to follow the children beyond two years post-surgery, all parties involved are hoping that further funding can be obtained to continue following these children up as these data will be unique.

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (2)

• Change in Gross Motor Function Measure (GMFM-66)

  The GMFM-66 is a clinical tool to evaluate gross mortar function change in children with cerebral palsy. It contains 66 items in the tool, which a aggregated using a predefined summary calculation of all completed items.

  Change from baseline, to 6 months, 12 months and 24 months.

• Change in the Cerebral Palsy Quality of Life Questionnaire for Children

  The Change in the Cerebral Palsy Quality of Life Questionnaire for Children, is a quality of life measure for children with cerebral palsy which can be completed by either the child, or the parent. It contains 53 items in the child version, and 65 items in the parent version.

  Change from Baseline, to 6 months, 12 months and 24 months

Secondary Outcomes (3)

• Duncan Ely Test: used to assess rectus femoris spasticity or tightness

  Change from Baseline, to 6 months, 12 months and 24 months

• Modified Ashworth Scale

  Change from Baseline, to 6 months, 12 months and 24 months

• Physiotherapy assessment measures: use of mobility and orthotic devices, and functional mobility scale.

  Change from Baseline, to 6 months, 12 months and 24 months

Eligibility Criteria

• Age: 3 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

All patients who have consented to the Selective Dorsal Rhizotomy (SDR) procedure in one of the five Trusts who are commissioned to do SDR.

You may qualify if:

• All patients who have consented to the SDR procedure in one of the five Trusts who are commissioned to do SDR.
• Children between the ages of 3 and 9 years with a diagnosis of spastic diplegic cerebral palsy (based on NICE guidance \[2\]).
• Dynamic spasticity in lower limbs affecting function and mobility and no dystonia
• MRI shows typical Cerebral palsy changes and no damage to key areas of brain controlling posture and coordination.
• GMFCS level II or III.
• No evidence of genetic or neurological progressive illness.
• Mild to moderate lower limb weakness with ability to maintain antigravity postures.
• No significant scoliosis or hip dislocation (Reimer's index \[10\] should be \<40%).
• In addition to the above clinical criteria there must be written agreement from the referring responsible commissioner confirming financial and resource commitment to provide the post operative physiotherapy package as outlined in the CTE SDR programme selection criteria \[5\].

You may not qualify if:

• Under 3 years of age, or older than 9 years.
• Gross Motor Function Classification System levels I, IV or V.

Sponsors & Collaborators

• King's College London: lead

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Janet Peacock, PhD

  King's College London, London, United Kingdom

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2016
• First Posted: September 19, 2016
• Study Start: March 1, 2014
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: March 1, 2019

Record last verified: 2017-12