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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT02664337
Other study ID # Pro00067150
Secondary ID
Status Suspended
Phase N/A
First received
Last updated
Start date February 2016
Est. completion date July 2024

Study information

Verified date June 2023
Source Duke University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is an observational study to test and validate a questionnaire and statistical model used to determine patient preferences regarding treatment for any one of 11 musculoskeletal conditions: hip arthritis, knee arthritis, hip labral tears and femoroacetabular impingement (FAI), osteochondritis dissecans, Achilles tendon rupture, patellofemoral dislocation, distal radius fracture, and fractures of the hip, ankle, tibia, and proximal humerus. This study aims to understand how multiple treatment variables, including pain, rehabilitation time, cost, and choice of surgical versus non-surgical intervention, impact patients' decision-making processes and ultimate choice of treatment.


Recruitment information / eligibility

Status Suspended
Enrollment 2310
Est. completion date July 2024
Est. primary completion date July 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: - Patient age criteria for each condition is listed below: 1. Hip arthritis: 50-80 years 2. Knee arthritis: 50-80 years 3. Hip labral tears and FAI: 18-65 4. Osteochondritis dissecans: parents with children between the ages of 8-18 5. Achilles tendon rupture: 25-60 years 6. Patellofemoral dislocation: parents with children between the ages of 8-18 and adults between 18-50 years of age 7. Distal radius fracture: 18-80 years 8. Hip fracture: 50-85 years 9. Ankle fracture: 18-80 years 10. Tibia fracture: 18-80 years 11. Proximal humerus fracture: 18-80 years 12. Ankle Arthritis: 40-80 years Exclusion Criteria: - Inability to read, understand and give effective English consent

Study Design


Intervention

Other:
Decision tool
A survey will be created for each condition that reflects the most important aspects of the corresponding treatment process.
Standard treatment information
Participants will receive information pertaining to one of the 12 specified musculoskeletal conditions. This information will reflect information commonly distributed to patients seeking to make a decision concerning treatment for their condition.

Locations

Country Name City State
United States Duke University Health System Durham North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Patient preferences survey - Hip Arthritis Patient-voiced preferences regarding treatment for hip arthritis based on questionnaires 3-5 years
Primary Patient preferences survey - Knee Arthritis Patient-voiced preferences regarding treatment for knee arthritis based on questionnaires 2 years
Primary Patient preferences survey - hip labral tears and FAI Patient-voiced preferences regarding treatment for hip labral tears and femoroacetabular impingement (FAI) based on questionnaires 3-5 years
Primary Patient preferences survey - Osteochondritis dissecans Patient-voiced preferences regarding treatment for osteochondritis dissecans based on questionnaires 3-5 years
Primary Patient preferences survey - Achilles tendon rupture Patient-voiced preferences regarding treatment for Achilles tendon rupture based on questionnaires 2 years
Primary Patient preferences survey - patellofemoral dislocation Patient-voiced preferences regarding treatment for patellofemoral dislocation based on questionnaires 2 years
Primary Patient preferences survey - distal radius fracture Patient-voiced preferences regarding treatment for distal radius fracture based on questionnaires 3-5 years
Primary Patient preferences survey - hip fracture Patient-voiced preferences regarding treatment for hip fracture based on questionnaires 3-5 years
Primary Patient preferences survey - ankle fracture Patient-voiced preferences regarding treatment for ankle fracture based on questionnaires 3-5 years
Primary Patient preferences survey - tibia fracture Patient-voiced preferences regarding treatment for tibia fracture based on questionnaires 3-5 years
Primary Patient preferences survey - proximal humerus fracture Patient-voiced preferences regarding treatment for proximal humerus fracture based on questionnaires 3-5 years
Primary Patient preferences survey - Ankle Arthritis Patient-voiced preferences regarding treatment for ankle arthritis based on questionnaires 3-5 years
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