NCT02664337

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,310

participants targeted

Target at P75+ for not_applicable

Timeline
13mo left

Started Feb 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Feb 2016Jul 2027

First Submitted

Initial submission to the registry

January 22, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 27, 2016

Completed
5 days until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
11.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

February 4, 2026

Status Verified

February 1, 2026

Enrollment Period

11.4 years

First QC Date

January 22, 2016

Last Update Submit

February 2, 2026

Conditions

ArthritisFemoroacetabular ImpingementOsteochondritis DissecansHip FracturesAnkle FracturesTibial Fractures

Outcome Measures

Primary Outcomes (12)

  • Patient preferences survey - Hip Arthritis

    Patient-voiced preferences regarding treatment for hip arthritis based on questionnaires

    3-5 years

  • Patient preferences survey - Knee Arthritis

    Patient-voiced preferences regarding treatment for knee arthritis based on questionnaires

    2 years

  • 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

  • Patient preferences survey - Osteochondritis dissecans

    Patient-voiced preferences regarding treatment for osteochondritis dissecans based on questionnaires

    3-5 years

  • Patient preferences survey - Achilles tendon rupture

    Patient-voiced preferences regarding treatment for Achilles tendon rupture based on questionnaires

    2 years

  • Patient preferences survey - patellofemoral dislocation

    Patient-voiced preferences regarding treatment for patellofemoral dislocation based on questionnaires

    2 years

  • Patient preferences survey - distal radius fracture

    Patient-voiced preferences regarding treatment for distal radius fracture based on questionnaires

    3-5 years

  • Patient preferences survey - hip fracture

    Patient-voiced preferences regarding treatment for hip fracture based on questionnaires

    3-5 years

  • Patient preferences survey - ankle fracture

    Patient-voiced preferences regarding treatment for ankle fracture based on questionnaires

    3-5 years

  • Patient preferences survey - tibia fracture

    Patient-voiced preferences regarding treatment for tibia fracture based on questionnaires

    3-5 years

  • Patient preferences survey - proximal humerus fracture

    Patient-voiced preferences regarding treatment for proximal humerus fracture based on questionnaires

    3-5 years

  • Patient preferences survey - Ankle Arthritis

    Patient-voiced preferences regarding treatment for ankle arthritis based on questionnaires

    3-5 years

Study Arms (2)

Decision tool

EXPERIMENTAL

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

Standard treatment information

ACTIVE COMPARATOR

"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

Interventions

Decision toolOTHER

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

Decision tool
Standard treatment informationOTHER

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.

Standard treatment information

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient age criteria for each condition is listed below:
  • Hip arthritis: 50-80 years
  • Knee arthritis: 50-80 years
  • Hip labral tears and FAI: 18-65
  • Osteochondritis dissecans: parents with children between the ages of 8-18
  • Achilles tendon rupture: 25-60 years
  • Patellofemoral dislocation: parents with children between the ages of 8-18 and adults between 18-50 years of age
  • Distal radius fracture: 18-80 years
  • Hip fracture: 50-85 years
  • Ankle fracture: 18-80 years
  • Tibia fracture: 18-80 years
  • Proximal humerus fracture: 18-80 years
  • Ankle Arthritis: 40-80 years

You may not qualify if:

  • Inability to read, understand and give effective English consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Health System

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

ArthritisFemoracetabular ImpingementOsteochondritis DissecansHip FracturesAnkle FracturesTibial Fractures

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsOsteochondritisBone DiseasesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesAnkle Injuries

Study Officials

  • Richard C. Mather III, MD, MBA

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2016

First Posted

January 27, 2016

Study Start

February 1, 2016

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

February 4, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)