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Completed

NCT Number: NCT03054753

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

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.

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Key information

Conditions

Rotator Cuff Tear Behavior Health Behavior Patient Acceptance of Health Care Patient Compliance Rotator Cuff Injuries Rupture Shoulder Injuries Tendon Injuries Treatment Adherence and Compliance Wounds and Injuries

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Balgrist University Hospital, University

Zurich, Zuri, 8008, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with rotator cuff repair and postoperative abduction for 6 weeks

Exclusion criteria

  • Revision surgery

Treatment and study plan

Abduction brace wearing time analysis

Behavioral

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.

Primary outcomes

  1. Objective abduction brace wearing time

    Time frame: 6 weeks postoperative

    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.

Secondary outcomes

  1. Correlation of compliance and functional outcome

    Time frame: 1 year postoperative

    Compliance: Constant score:

    Compliance= objective wearing time a day in correlation to functional outcome (Shoulder Constant score 0-100pts)

  2. Correlation of compliance and subjective outcome

    Time frame: 3 months postoperative

    Compliance:subjective shoulder value Compliance = objective wearing time a day in correlation to subjective shoulder value

  3. Correlation of compliance and patient satisfaction

    Time frame: 3 months postoperative

    Compliance: patient satisfaction Compliance = objective wearing time a day in correlation to patient satisfaction (excellent =4, good =3, moderate=2, poor=1)

Sponsors and collaborators

Lead sponsor

Balgrist University Hospital

Other

Registry information

Acronym: SENSABDUKT

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Feb 16, 2017
Registry last updated
Jul 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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