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Trial record 10 of 23 for:    Osteochondritis Dissecans

Conjoint Analysis of Patient Preferences in Joint Interventions

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ClinicalTrials.gov Identifier: NCT02664337
Recruitment Status : Recruiting
First Posted : January 27, 2016
Last Update Posted : May 6, 2019
Sponsor:
Information provided by (Responsible Party):
Duke University

Brief 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.

Condition or disease Intervention/treatment Phase
Arthritis Femoroacetabular Impingement Osteochondritis Dissecans Hip Fractures Ankle Fractures Tibial Fractures Other: Decision tool Other: Standard treatment information Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2310 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Conjoint Analysis of Patient Preferences in Joint Interventions
Study Start Date : February 2016
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021


Arm Intervention/treatment
Experimental: Decision tool
A "decision tool" will be provided to participants who currently or previously have had one of the following 12 musculoskeletal conditions: hip arthritis, knee arthritis, ankle 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.
Other: Decision tool
A survey will be created for each condition that reflects the most important aspects of the corresponding treatment process.

Active Comparator: Standard treatment information
"Standard treatment information" will be provided to participants who currently or previously have had one of the following 12 musculoskeletal conditions: hip arthritis, knee arthritis, ankle 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.
Other: 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.




Primary Outcome Measures :
  1. Patient preferences survey - Hip Arthritis [ Time Frame: 3-5 years ]
    Patient-voiced preferences regarding treatment for hip arthritis based on questionnaires

  2. Patient preferences survey - Knee Arthritis [ Time Frame: 2 years ]
    Patient-voiced preferences regarding treatment for knee arthritis based on questionnaires

  3. Patient preferences survey - hip labral tears and FAI [ Time Frame: 3-5 years ]
    Patient-voiced preferences regarding treatment for hip labral tears and femoroacetabular impingement (FAI) based on questionnaires

  4. Patient preferences survey - Osteochondritis dissecans [ Time Frame: 3-5 years ]
    Patient-voiced preferences regarding treatment for osteochondritis dissecans based on questionnaires

  5. Patient preferences survey - Achilles tendon rupture [ Time Frame: 2 years ]
    Patient-voiced preferences regarding treatment for Achilles tendon rupture based on questionnaires

  6. Patient preferences survey - patellofemoral dislocation [ Time Frame: 2 years ]
    Patient-voiced preferences regarding treatment for patellofemoral dislocation based on questionnaires

  7. Patient preferences survey - distal radius fracture [ Time Frame: 3-5 years ]
    Patient-voiced preferences regarding treatment for distal radius fracture based on questionnaires

  8. Patient preferences survey - hip fracture [ Time Frame: 3-5 years ]
    Patient-voiced preferences regarding treatment for hip fracture based on questionnaires

  9. Patient preferences survey - ankle fracture [ Time Frame: 3-5 years ]
    Patient-voiced preferences regarding treatment for ankle fracture based on questionnaires

  10. Patient preferences survey - tibia fracture [ Time Frame: 3-5 years ]
    Patient-voiced preferences regarding treatment for tibia fracture based on questionnaires

  11. Patient preferences survey - proximal humerus fracture [ Time Frame: 3-5 years ]
    Patient-voiced preferences regarding treatment for proximal humerus fracture based on questionnaires

  12. Patient preferences survey - Ankle Arthritis [ Time Frame: 3-5 years ]
    Patient-voiced preferences regarding treatment for ankle arthritis based on questionnaires



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02664337


Contacts
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Contact: Carolyn A Hutyra 919-660-2504 carolyn.hutyra@dm.duke.edu

Locations
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United States, North Carolina
Duke University Health System Recruiting
Durham, North Carolina, United States, 27710
Contact: Carolyn Hutyra    919-660-2504    carolyn.hutyra@dm.duke.edu   
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Richard C. Mather III, MD, MBA Duke University

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02664337     History of Changes
Other Study ID Numbers: Pro00067150
First Posted: January 27, 2016    Key Record Dates
Last Update Posted: May 6, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Osteochondritis
Osteochondritis Dissecans
Fractures, Bone
Hip Fractures
Ankle Fractures
Tibial Fractures
Femoracetabular Impingement
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries
Joint Diseases
Musculoskeletal Diseases
Pathologic Processes
Bone Diseases
Cartilage Diseases
Connective Tissue Diseases