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

Rotator Cuff Tear Clinical Trial

— SENSABDUKT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03054753
• Other study ID #: W633
• Status: Completed
• Phase: N/A
• Start date: March 31, 2017
• Est. completion date: July 1, 2021

Study information

• Verified date: July 2021
• Source: Balgrist University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: July 1, 2021
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Revision surgery

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tear

Intervention

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.

Locations

Country	Name	City	State
Switzerland	Balgrist University Hospital, University	Zurich	Zuri

Sponsors (1)

Lead Sponsor	Collaborator
Balgrist University Hospital

Country where clinical trial is conducted

Switzerland, 

References & Publications (4)

Miller DJ, Franzone JM, Matsumoto H, Gomez JA, Avendaño 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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