Early Nerve Reconstruction Approach in Tetraplegic Patients With Dysfunctional Upper Extremity: a Randomized Controlled Trial.
试验速览
- 阶段
- 4 期
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Medical Research Grading (MRC) system
研究概览
简要总结
The cervical spine is most commonly injured, accounting for 53.4% of spinal injuries. More than 40% of all spinal injuries occur at either C4, C5 or C6 levels leading to variable loss of function in the upper extremities.
Traditionally, patients sustaining a cervical spine injury were followed for 2 years to ensure that recovery had stabilized before offering upper extremity reconstruction. This type of reconstruction includes active muscle transfer, tendon transfer and joint fusion.
Patients are most commonly assessed immediately at the time of injury. Muscle testing is commonly performed using Medical Research Grading System (MRC).
Although complete neurologic stabilization may not be complete until 2 years post-injury, in the group with initial grade 0 muscle strength after the acute phase of injury, expectations of improved muscle strength to or beyond grade 3 after 4-6 months is minimal. And grade 3 muscle strength is felt to be the minimum useful functional strength in a muscle group.
The investigators propose an early nerve reconstruction approach to the tetraplegic patient with dysfunction of the upper extremity to augment the available tendon transfers.
A comparative pilot study is proposed to determine the effectiveness of supinator branch to posterior interosseous nerve (PIN) transfer in 5 patients with cervical spine injury. Patient who fits inclusion criteria will be offered the opportunity to be involved in the study and reviewed at 6 months from injury. If the patient still has not regained Grade 3 power in finger or thumb extension, they will be randomized to be in a surgical group or non-surgical group.
If informed consent is obtained, then surgery will be completed between 6-9 months from the patient's original cervical spine injury. The patient will be followed at regular intervals post-operatively with expectation of 18-24 month follow-up.
Measures will be used pre and post-operatively for comparison. Measures will include MRC muscle grade (EDC), range of motion, Disability of the Arm, Shoulder, and Hand Questionnaire (DASH), and The Graded Redefined Assessment of Strength Sensibility and Prehension (GRASSP) (Kalsi-Ryan, 2011).
详细描述
There is currently no published data showing the effect of early nerve transfer on hand function recovery of the subset of tetraplegic patients, who have initial grade 0 muscle strength immediately after their injuries. We are interested in conducting a pilot study comparing the surgical group to the non-surgical group. A larger trial will be planned if the preliminary results show positive improvement in hand function recovery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cervical spine injury with functional loss in the upper extremity
- •Greater than 4 months out from C-spine injury
- •Stable motor recovery
- •Medically stable
- •International Classification for Surgery of the Hand in Tetraplegia of 0-5 at 6 months
- •Grade 0 finger/thumb extension at 6 months
- •Subjects fluent in English or when not fluent, an appropriate translator is present
排除标准
- •Unstable patient
- •Joint contracture
- •Spasticity
- •Loss of function is expected to be improved by reliable tendon transfer, tenodesis or arthrodesis that is available
- •Evidence of recovering finger/thumb extension at 4-6 months
- •Greater than 12 months from spinal cord injury
- •Subject not fluent in English or an appropriate translator not available
研究组 & 干预措施
Surgical arm
Nerve reconstruction:
Early nerve transfer (around 6-9 months post cervical spine injury) will be performed in this group of patients.
干预措施: Nerve reconstruction (Procedure)
Non-surgical (or observed)
Patients in this group will receive standard of care and be observed for up to two years post injury.
结局指标
主要结局
Medical Research Grading (MRC) system
时间窗: 24 months post-op
A grading system testing the strength of muscles and ranging from grade 0 (weakest) to grade 5 (strongest).
Medical Research Grading (MRC) System
时间窗: 9 months post-op
A grading system testing the strength of muscles and ranging from grade 0 (weakest) to grade 5 (strongest).
Medical Research Grading (MRC) System
时间窗: Baseline (before surgery)
A grading system testing the strength of muscles and ranging from grade 0 (weakest) to grade 5 (strongest).
Medical Research Grading (MRC) system
时间窗: 12 months post-op
A grading system testing the strength of muscles and ranging from grade 0 (weakest) to grade 5 (strongest).
次要结局
- Range of motion(24 months post-op)
- DASH questionnaire(24 months post-op)
- Range of motion(Baseline (before surgery))
- Range of motion(9 months post-op)
- Range of motion(12 months post-op)
- DASH questionnaire(Baseline (before surgery))
- DASH questionnaire(9 months post-op)
研究者
Sean Bristol
Principal Investigator
University of British Columbia