Outcomes of Surgical Excision of Dorsal Wrist Ganglia With or Without Partial Wrist Denervation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Pain behavior measured with the Patient-Reported Outcomes Measurement Information (PROMIS) Pain Behavior instrument
研究概览
简要总结
The purpose of this study is to determine if a statistical significance exists between outcomes of patients treated for dorsal wrist ganglion cyst with excision alone versus excision and the addition of a partial wrist denervation by resecting the common terminal sensory branch of the PIN (posterior interosseus nerve). Our hypothesis is that addition of PIN improves outcome after dorsal wrist ganglion excision as indicated by post-operative pain, function, ability to perform activities of daily living, and physical exam findings.
详细描述
The primary endpoint will be outcomes on subject surveys and questionnaires. Data will be collected pre- and post-operatively at 2 weeks, 12 weeks, 6 months, and one year. Four questionnaires will be used, including the Visual Analog Pain Score (VAS), Disabilities of the Arm, Shoulder, and Hand (QuickDASH) questionnaire, as well as the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference (PI), and the PROMIS Pain Behavior (PB) questionnaires.
Secondary outcomes include physical examination consisting of pre- and post-operative pinch and grip strength testing, and active range of motion including wrist flexion and extension ulnar and radial deviation, and weight bearing extension. These will be performed at 2 weeks, 12 weeks, and 6 months post-operatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The patient and the study team member who is performing the physical exam (including range of motion and grip/pinch strength testing) will be blinded to the randomization.
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
- •Greater than or equal to 18 years of age
- •Gender: male/female (non-pregnant)
- •Diagnosis of symptomatic (pain and limited ability to perform activities of daily living) dorsal wrist ganglion cyst
- •Subjects who have chosen surgical management for their ganglion cyst diagnosis
- •Fluent in written and spoken English
- •Subject is able to provide voluntary, written informed consent
- •Subject, in the opinion of the clinical investigator, is able to understand the clinical investigation and is willing to perform all study procedures and follow-up visits
- •Non-Prisoners
排除标准
- •Less than 18 years of age
- •Non-elective surgery for this diagnosis
- •Chronic wrist instability of the operative extremity
- •Comorbid neurologic maladies of the operative extremity
- •Prior wrist surgery on either extremity
- •Non-English speaking
- •Prisoners
- •Pregnancy
- •Cognitive Impairment
研究组 & 干预措施
Dorsal wrist ganglion alone (DWG)
Dorsal wrist ganglion excision alone
干预措施: Dorsal wrist ganglion alone (DWG) (Procedure)
DWG with PIN
Dorsal wrist ganglion excision with posterior interosseus neurectomy (PIN)
干预措施: DWG/PIN (Procedure)
结局指标
主要结局
Pain behavior measured with the Patient-Reported Outcomes Measurement Information (PROMIS) Pain Behavior instrument
时间窗: Preop to One Year Post-Op
This instrument measures self-reported external manifestations of pain: behaviors that typically indicate to others that an individual is experiencing pain.
Pain measured with the Visual Analog Pain Scale (VAS)
时间窗: Preop to One Year Post-Op
Self-report measurement that assesses a person's perceived level of pain
Physical Function measured with the Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH)
时间窗: Preop to One Year Post-Op
11-Item questionnaire that measures physical function and symptoms in people with musculoskeletal disorders of the upper limb
Pain interference measured with the Patient-Reported Outcomes Measurement Information (PROMIS) Pain Interference instrument
时间窗: Preop to One Year Post-Op
This instrument measures the self-reported consequences of pain on relevant aspects of one's life and may include the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities.
次要结局
- Change in strength utilizing finger lateral pinch measurements(Preop to 6 Months Post-Op)
- Change in strength utilizing finger three-point pinch measurements(Preop to 6 Months Post-Op)
- Change in strength utilizing hand grip measurements(Preop to 6 Months Post-Op)
- Change in strength utilizing finger tip pinch measurements(Preop to 6 Months Post-Op)
- Change in wrist flexion(Preop to 6 Months Post-Op)
- Change in wrist extension(Preop to 6 Months Post-Op)
- Change in wrist weight bearing extension(Preop to 6 Months Post-Op)
- Change in wrist radial deviation(Preop to 6 Months Post-Op)
- Change in wrist ulnar deviation(Preop to 6 Months Post-Op)
研究者
Kenneth Taylor, M.D.
Professor of Orthopaedics and Rehabilitation
Milton S. Hershey Medical Center