NCT03054753

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2017

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 16, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

March 31, 2017

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

July 21, 2021

Status Verified

July 1, 2021

Enrollment Period

3.7 years

First QC Date

January 31, 2017

Last Update Submit

July 20, 2021

Conditions

Rotator Cuff Tear

Keywords

Abduction braceComplianceRotator cuff tearRotator cuff repair

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Correlation of compliance and functional outcome

    1 year postoperative

  • Correlation of compliance and subjective outcome

    3 months postoperative

  • Correlation of compliance and patient satisfaction

    3 months postoperative

Study Arms (1)

Abduction brace wearing time analysis

OTHER

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

Interventions

Abduction brace wearing time analysisBEHAVIORAL

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.

Abduction brace wearing time analysis

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Revision surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Balgrist University Hospital, University

Zurich, Zuri, 8008, Switzerland

Location

Related Publications (4)

  • Silverio LM, Cheung EV. Patient adherence with postoperative restrictions after rotator cuff repair. J Shoulder Elbow Surg. 2014 Apr;23(4):508-13. doi: 10.1016/j.jse.2013.09.018. Epub 2014 Feb 24.

    PMID: 24581418BACKGROUND

  • Miller DJ, Franzone JM, Matsumoto H, Gomez JA, Avendano J, Hyman JE, Roye DP Jr, Vitale MG. Electronic monitoring improves brace-wearing compliance in patients with adolescent idiopathic scoliosis: a randomized clinical trial. Spine (Phila Pa 1976). 2012 Apr 20;37(9):717-21. doi: 10.1097/BRS.0b013e31822f4306.

    PMID: 22517480BACKGROUND

  • Morton A, Riddle R, Buchanan R, Katz D, Birch J. Accuracy in the prediction and estimation of adherence to bracewear before and during treatment of adolescent idiopathic scoliosis. J Pediatr Orthop. 2008 Apr-May;28(3):336-41. doi: 10.1097/BPO.0b013e318168d154.

    PMID: 18362800BACKGROUND

  • Takemitsu M, Bowen JR, Rahman T, Glutting JJ, Scott CB. Compliance monitoring of brace treatment for patients with idiopathic scoliosis. Spine (Phila Pa 1976). 2004 Sep 15;29(18):2070-4; discussion 2074. doi: 10.1097/01.brs.0000138280.43663.7b.

    PMID: 15371711BACKGROUND

MeSH Terms

Conditions

Rotator Cuff InjuriesPatient Compliance

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon InjuriesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Samy Bouaichqa, MD PD

    Balgrist University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2017

First Posted

February 16, 2017

Study Start

March 31, 2017

Primary Completion

December 1, 2020

Study Completion

July 1, 2021

Last Updated

July 21, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)