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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03054753
Recruitment Status : Enrolling by invitation
First Posted : February 16, 2017
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
Balgrist University Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Rotator Cuff Tear Behavioral: Abduction brace wearing time analysis Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Sensor Controlled Compliance Analysis of Shoulder Abduction Splint After Rotator Cuff Repair
Actual Study Start Date : March 31, 2017
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 31, 2020

Arm Intervention/treatment
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Revision surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03054753


Locations
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Switzerland
Balgrist University Hospital, University
Zurich, Zuri, Switzerland, 8008
Sponsors and Collaborators
Balgrist University Hospital
Investigators
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Study Chair: Samy Bouaichqa, MD PD Balgrist University Hospital
Publications:
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Responsible Party: Balgrist University Hospital
ClinicalTrials.gov Identifier: NCT03054753    
Other Study ID Numbers: W633
First Posted: February 16, 2017    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Balgrist University Hospital:
Abduction brace
Compliance
Rotator cuff tear
Rotator cuff repair
Additional relevant MeSH terms:
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Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries