Prospective Sensor Controlled Compliance Analysis of Shoulder Abduction Splint After Rotator Cuff Repair
Last updated on July 2021Recruitment
- Recruitment Status
- Enrolling by invitation
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Rotator Cuff Tear
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 16 years and 125 years
- Gender
- Both males and females
Description
After arthroscopic reconstruction of a rotator cuff tear the healing depends on a tension free positioning of the reconstructed tendon. Therefore a abduction brace is administered routinely for 6 weeks. The re-rupture rate of rotator cuff reconstruction is about 30%. One of the reason may be mechani...
After arthroscopic reconstruction of a rotator cuff tear the healing depends on a tension free positioning of the reconstructed tendon. Therefore a abduction brace is administered routinely for 6 weeks. The re-rupture rate of rotator cuff reconstruction is about 30%. One of the reason may be mechanical overuse caused by non wearing of the abduction brace. From experience the investigators suggest that the abduction brace wearing behaviour differs among patients. The participant´s wearing compliance has been evaluated by Silverio et al. with a questionary but never with a sensor. In this study the investigators want to analyse the participant´s abduction brace wearing compliance by using an sensor, which is implanted in the abduction brace and monitors the wearing time, which reveals the objective wearing time. The sensor is a certificated sensor, which measures temperature in °C every 15 min. If the abduction brace is worn by the participants the body temperature can be captured by the sensor. If the measured temperature is over 33°C the sensor capture the time period as a "worn" time. With this measurements the abduction brace wear time should be captured objectively. A similar kind of sensors were used to evaluate the wearing time of scoliosis-braces in patients with adolescent idiopathic scoliosis (Miller DJ eta al., Morton A et al., Takemitsu et al.) With a questionary the participants are asked of the wearing time before they will be informed about the implanted sensor. This answer represents the subjective wearing time. The first endpoint of the study is the evaluation of the objective and subjective abduction wearing time. The second endpoint is the evaluation of the correlation between compliance and subjective outcome.
Tracking Information
- NCT #
- NCT03054753
- Collaborators
- Not Provided
- Investigators
- Study Chair: Samy Bouaichqa, MD PD Balgrist University Hospital