NCT01897272

Post-Operative Splinting After Short-Incision Carpal Tunnel Release: a Prospective Study

Post-Operative Splinting After Short-Incision Carpal Tunnel Release: a Prospective, Randomized Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: Christine M. Kleinert Institute for Hand and Microsurgery · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study is for patients who are schedule to have carpal tunnel release surgery. The investigators have developed this study in order to determine if post-operative splinting is effective in improvement of patient outcomes after this surgical procedure. The study is being conducted under the direction of Huey Tien, MD. The purpose of this study is to determine if post-operative splinting is effective in improving patient outcomes after having short-incision carpal tunnel release. The investigators will randomize each patient into group 1, splinting after surgery or group 2 no splinting after surgery. Each group will have the same outcome measurements done to determine the best outcome of the two groups.

Detailed description

Your participation in this study will last for five office visits of approximately 30 minutes each. If you decide to participate in this study, we would first have you come to clinic where you would undergo some standard measurements. This includes measuring grip and key pinch strength and completing a patient questionnaire. During your visits we will scan the cross-sectional area of the median nerve at the pisiform bone level to determine the level of CTS with the Ultrasound Biomiscroscopy machine (Vevo 2100). This is a new technique with a machine similar to a regular ultrasound machine. The primary difference is that the frequency of soundwaves is higher than a standard ultrasound machine. There are no known significant risks associated with the use of this machine. At this time the machine is experimental, and is not currently approved by the FDA for clinical use. However, this device is not considered to pose significant risk. Candidates for this study must have been diagnosed with single carpal tunnel syndrome and are going to receive nerve decompression with short incision, over the age of 18, and able to give informed consent to participate in a research study.

Conditions

• Carpal Tunnel Syndrome

Interventions

Type	Name	Description
BEHAVIORAL	Splinting	One group will have their wrist splinted after their carpal tunnel release surgery.

Timeline

• Start date: 2012-09-01
• Primary completion: 2019-09-01
• Completion: 2019-09-01
• First posted: 2013-07-11
• Last updated: 2018-01-25

Locations

2 sites across 1 country: United States