Prospective Sensor Controlled Compliance Analysis of Shoulder Abduction Splint After Rotator Cuff Repair

Study Overview
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Brief Summary
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The postoperative shoulder rehabilitation in an abduction brace after rotator cuff reconstruction of the shoulder is crucial for a successful healing of the reconstruction. In this study the investigators want to analyse the abduction brace-wearing time using a electronic sensor, which is implanted in the abduction brace. The participants will be informed about the sensor after completion of the abduction brace rehabilitation 6 weeks postoperatively.

Detailed Description
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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.

Official Title
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Prospective Sensor Controlled Compliance Analysis of Shoulder Abduction Splint After Rotator Cuff Repair

Conditions
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Rotator Cuff Tear

Intervention / Treatment
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* Behavioral: Abduction brace wearing time analysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with rotator cuff repair and postoperative abduction for 6 weeks Exclusion Criteria: Revision surgery

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Abduction brace wearing time analysis<br>The abduction brace wearing time analysis is performed in patients, who undergo a rotator cuff repair with postoperative abduction brace treatment | Behavioral: Abduction brace wearing time analysis<br>* To evaluate the patient´s abduction brace wearing time a sensor = Orthotimer® (Rollerwerk, 72336 Balingen, Germany, www.orthotimer.com) is implanted in the abduction brace. The sensor measures the body temperature of the patient. Through that the wearing time can be evaluated.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective abduction brace wearing time | A sensor is implanted in the abduction brace, which captures every 15min. the temperature. If the abduction brace is worn the sensor can measure the body temperature. The objective wearing time can be evaluated. | 6 weeks postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of compliance and functional outcome | Compliance: Constant score: Compliance= objective wearing time a day in correlation to functional outcome (Shoulder Constant score 0-100pts) | 1 year postoperative | 
| Correlation of compliance and subjective outcome | Compliance:subjective shoulder value Compliance = objective wearing time a day in correlation to subjective shoulder value | 3 months postoperative | 
| Correlation of compliance and patient satisfaction | Compliance: patient satisfaction Compliance = objective wearing time a day in correlation to patient satisfaction (excellent =4, good =3, moderate=2, poor=1) | 3 months postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Abduction brace, Compliance, Rotator cuff tear, Rotator cuff repair