Recruiting

Observational Study

Sponsor:

University of Colorado, Denver

Code:

NCT04294693

Conditions

Total Joint Arthroplasty

Eligibility Criteria

Sex: All

Age: 10 - 25

Healthy Volunteers: Not accepted

Study Details

Brief summary:

The primary purpose of this study is to examine the functional ability and quality of life in those patients who received a total joint arthroplasty (TJA) for reasons other than having a solid tumor at the location of the joint.

Conditions

Total Joint Arthroplasty

Study ID

NCT04294693

Start date

Jun 3, 2019

Status verified date

Dec, 2025

Completion date

Mar, 2061

Anticipated

Primary completion date

Mar, 2050

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 25

Healthy Volunteers: Not accepted

Inclusion Criteria: Populations 1,2,3

  • Age between 10 years and 25 years
  • Undergoing or have undergone total joint arthroplasty at Children's Hospital Colorado for non-solid tumor related reasons
  • Treated at Children's Hospital Colorado by Dr. Nathan Donaldson, DO or Dr. Steven Thorpe, MD or previously by Travis Heare, MD

Exclusion Criteria: Populations 1,2,3

  • Subjects and/or parents not capable of completing basic questionnaires in English (HRQL data will not be collected from non-English speaking subjects because we do not have access to versions of these questionnaires that have been validated in languages other than English. These patients may be included at a later date when validated questionnaires are available).
  • Subjects who underwent hemiarthroplasties, failed rotationplasty to arthroplasty conversions, or joint arthroplasty directly related to a tumor at the location of the joint
  • Subjects diagnosed with mucopolysaccharidoses (MPS), pseudorheumatoid chondrodysplasia, or diastrophic dwarfism

Inclusion Criteria: Population 4

  • Age between 10 years and 25 years
  • Treated at Children's Hospital Colorado by Dr. Nathan Donaldson, DO, or Dr. Steven Thorpe, MD or previously by Travis Heare, MD
  • Symptomatic joint pain treated non-invasively via lifestyle modifications, over the counter or prescription pain medication, nerve blocks or steroid injections, and/or physical therapy
  • Symptomatic joint pain treated via core decompression surgery at Children's Hospital Colorado by Dr. Nathan Donaldson, DO, or Dr. Steven Thorpe, MD, or previously by Travis Heare, MD

Exclusion Criteria: Population 4

  • Patients who underwent a joint arthroplasty directly related to a tumor at the location of the joint at Children's Hospital Colorado. Patients undergoing or have undergone total joint arthroplasty at Children's Hospital Colorado for non-solid tumor related reasons
  • Subjects diagnosed with mucopolysaccharidoses (MPS), pseudorheumatoid chondrodysplasia, or diastrophic dwarfism

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

Recent Patients

Subjects that have undergone surgical intervention within the past two years from date of study approval and received a total joint arthroplasty and follow up care with Dr. Nathan Donaldson or Dr. Steven Thorpe in the Orthopedics Institute at Children's Hospital Colorado

New Patients

Subjects that are scheduled to undergo a total joint arthroplasty and/or receive follow-up care with Dr. Nathan Donaldson or Dr. Steven Thorpe at Children's Hospital Colorado

Long-term follow up Patients

Subjects that received a total joint arthroplasty for non-solid tumor malignancies before May 1, 2017 and no longer follow-up in clinic with Dr. Nathan Donaldson

Control Group Patients

Subjects with a clinical relationship to Dr. Nathan Donaldson or Dr. Steven Thorpe at Children's Hospital Colorado to act as a control group for statistical matching of the above populations.

Primary outcome measure

  • Standard of Care Data (routinely collected in clinic) [ Time Frame: 10 years ]
  • Research Data: Health Related Quality of Life instrument [ Time Frame: 10 years ]
  • Research Data: Health Related Quality of Life instrument [ Time Frame: 10 years ]
  • Research Data: Health Related Quality of Life instrument [ Time Frame: 10 years ]

Central Contacts and Locations

Central contacts

Mia Lundin

720-777-4871mia.lundin@childrenscolorado.org

Locations

Children's Hospital Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Mia Lundin

720-777-4871

Principal Investigator:

Nathan Donaldson, DO

More Information

Sponsor

University of Colorado, Denver

Last update posted

Apr 20, 2026

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2026-04-20.