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Driving After Shoulder Surgery

Driving After Arthroscopic Rotator Cuff Repair or Shoulder Arthroplasty

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04196218
Enrollment
150
Registered
2019-12-12
Start date
2025-12-31
Completion date
2026-06-30
Last updated
2023-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shoulder

Brief summary

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.

Interventions

Computer simulated driving assessment

Sponsors

The Hawkins Foundation
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Driving Assessmentsurgery through 12 weeks post-opClinical Driving Simulator

Secondary

MeasureTime frameDescription
Strengthsurgery through 12 weeks post-opMeasuring shoulder strength
Visual Analog Pain Scoresurgery through 12 weeks post-opPatient reported level of pain on a scale of 0 to 10, with 10 being extreme pain and 0 being no pain
Single Alpha Numeric Evaluation of the shouldersurgery through 12 weeks post-opPercentage of normal for affected shoulder between 0 and 100, with 100 being a perfectly normal shoulder and 0 being a completely abnormal shoulder
Range of Motionsurgery through 12 weeks post-opMeasuring shoulder range of motion
Brief Resilience Scalesurgery through 12 weeks post-opPatient reported resilience on a scale of 0 to 30, with 30 indicating high resilience and 0 indicating low resilience
Shoulder functionsurgery through 12 weeks post-opShoulder function as measured by American Shoulder and Elbow Surgeons assessment
Veterans Rand 12 Item Health Surveysurgery through 12 weeks post-opPatient 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

Contacts

Primary ContactStephan Pill, MD
stephan.pill@prismahealth.org864 454-7394
Backup ContactKyle J Adams
kyle.adams@hawkinsfoundation.com864 454 7458

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026