Total Joint Arthroplasty in a Pediatric Population

NCT04294693 | Recruiting DMC

• 2 other identifiers: 19-0306.ccP30CA046934
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• Standard of Care Data (routinely collected in clinic)

  Demographic information such as specific diagnoses leading to joint degeneration, age at diagnosis, type of medical treatments leading to need for joint replacement, previous treatments for joint including surgeries, complications, etc.

  10 years

• Research Data: Health Related Quality of Life instrument

  1\. Short Form-36 version 2 (SF-36v2)

  10 years

• Research Data: Health Related Quality of Life instrument

  2\. Oxford 12 Questionnaire

  10 years

• Research Data: Health Related Quality of Life instrument

  3\. Modified Harris Hip Score Questionnaire

  10 years

Study Arms (4)

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.

Eligibility Criteria

• Age: 10 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

* Study Population 1. Recent Patients: Subjects that have undergone surgical intervention within the past 2 years from date of study approval \& received a total joint arthroplasty \& follow up care with Dr. Nathan Donaldson or Dr. Steven Thorpe in the Orthopedics Institute at Children's Hospital Colorado . * Study Population 2. New Patients: Subjects that are scheduled to undergo a total joint arthroplasty \&/or receive follow-up care with Dr. Nathan Donaldson or Dr. Steven Thorpe at Children's Hospital Colorado . * Study Population 3. Long-term follow up Patients: Subjects that received a total joint arthroplasty for non-solid tumor malignancies before 05/01/2017 \& no longer follow-up in clinic with Dr. Nathan Donaldson. * Study Population 4. 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.

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

RECRUITING

Study Officials

• Nathan Donaldson, DO

  Children's Hospital Colorado

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mia Lundin

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2020
• First Posted: March 4, 2020
• Study Start: June 3, 2019
• Primary Completion (Estimated): March 1, 2050
• Study Completion (Estimated): March 1, 2061
• Last Updated: April 20, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)