Driving After Shoulder Surgery

Driving After Arthroscopic Rotator Cuff Repair or Shoulder Arthroplasty

Patients undergoing a shoulder arthroplasty or rotator cuff repair will be enrolled in the study. Patients will be asked to undergo driving simulator assessments post-operatively in ATI Physical Therapy for up to 12 weeks after surgery in order to determine when it may be safe for them to return to driving. Additional assessments include patient-reported outcomes, range of motion, and strength measures, which are all standard of care. Study participation concludes when the patient passes the driving simulator test.

Study Overview

• Status: Not yet recruiting
• Conditions: Shoulder
• Intervention / Treatment: Other: Driving simulator

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stephan Pill, MD; Phone Number: 864 454-7394; Email: stephan.pill@prismahealth.org
• Study Contact Backup: Name: Kyle J Adams; Phone Number: 864 454 7458; Email: kyle.adams@hawkinsfoundation.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients undergoing either Rotator Cuff Repair or Shoulder arthroplasty from participating surgeon
2. Patients receiving physical therapy from ATI Patewood clinic
3. Must be able and willing to complete all study assessments and to be followed for the full course of the study.
4. Must be able to read, write and follow instructions in English.
5. In the opinion of the investigator, is that they subject is competent to participate in study activities
6. Prior to injury, patient was routinely driving.

Exclusion Criteria:

1. Prior shoulder surgery in the last 90 day
2. Individuals with a history of any underlying neurological conditions

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Driving assessment; All subjects will undergo a driving assessment(s) following shoulder surgery.	Other: Driving simulator; Computer simulated driving assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Driving Assessment	Clinical Driving Simulator	surgery through 12 weeks post-op

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Range of Motion	Measuring shoulder range of motion	surgery through 12 weeks post-op
Strength	Measuring shoulder strength	surgery through 12 weeks post-op
Visual Analog Pain Score	Patient reported level of pain on a scale of 0 to 10, with 10 being extreme pain and 0 being no pain	surgery through 12 weeks post-op
Single Alpha Numeric Evaluation of the shoulder	Percentage of normal for affected shoulder between 0 and 100, with 100 being a perfectly "normal" shoulder and 0 being a completely "abnormal" shoulder	surgery through 12 weeks post-op
Veterans Rand 12 Item Health Survey	Patient reported quality of life. Score contains a physical component and mental component score. Both scales are continuous and values range from 0 to 70, with higher scoring indicating higher physical and mental component scores	surgery through 12 weeks post-op
Brief Resilience Scale	Patient reported resilience on a scale of 0 to 30, with 30 indicating high resilience and 0 indicating low resilience	surgery through 12 weeks post-op
Shoulder function	Shoulder function as measured by American Shoulder and Elbow Surgeons assessment	surgery through 12 weeks post-op

Collaborators and Investigators

• Sponsor: The Hawkins Foundation

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: December 9, 2019
• First Submitted That Met QC Criteria: December 11, 2019
• First Posted (Actual): December 12, 2019

Study Record Updates

• Last Update Posted (Estimated): December 19, 2023
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: Pro00095486

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No