Conjoint Analysis of Patient Preferences in Joint Interventions

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 85 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02664337
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Duke University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Richard C. Mather III, MD, MBA
Principal Investigator Affiliation Duke University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Enrolling by invitation
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Arthritis, Femoroacetabular Impingement, Osteochondritis Dissecans, Hip Fractures, Ankle Fractures, Tibial Fractures
Arms & Interventions

Arms

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.

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.

Interventions

Other: - Decision tool

A survey will be created for each condition that reflects the most important aspects of the corresponding treatment process.

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Duke University Health System, Durham, North Carolina

Status

Address

Duke University Health System

Durham, North Carolina, 27710