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

July 20, 2021 updated by: Balgrist University Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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 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.

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Zuri
      • Zurich, Zuri, Switzerland, 8008
        • Balgrist University Hospital, University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Revision surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Abduction brace wearing time analysis
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 weeks postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
1 year postoperative
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 months postoperative
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)
3 months postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Balgrist University Hospital

Investigators

  • Study Chair: Samy Bouaichqa, MD PD, Balgrist University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2017

Primary Completion (Actual)

December 1, 2020

Study Completion (Actual)

July 1, 2021

Study Registration Dates

First Submitted

January 31, 2017

First Submitted That Met QC Criteria

February 13, 2017

First Posted (Actual)

February 16, 2017

Study Record Updates

Last Update Posted (Actual)

July 21, 2021

Last Update Submitted That Met QC Criteria

July 20, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • W633

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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