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NCT Number: NCT04294693

Total Joint Arthroplasty in a Pediatric Population

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.

Recruiting

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Key information

Age range

10 year–25 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location status: Recruiting

Location contact

Mia Lundin

CONTACT

720-777-4871

Nathan Donaldson, DO

PRINCIPAL_INVESTIGATOR

About this study

Patients who undergo a total knee arthroplasty (TKA) or total hip arthroplasty(THA) for non-solid tumor related reasons, are most often those children who developed osteonecrosis or avascular necrosis(AVN) as a side effect of their therapy for leukemia. Other patients undergo TKA or THA after degeneration of their joints secondary to trauma, infection, rheumatologic conditions, or congenital deformity. While not all cases of injury to the knee or hip result in the need for a joint replacement, the quality of life is believed to be improved in these children, as having a functioning joint without pain is believed to be better for the patients' quality of life than ambulating with a painful and/or partially necrotic joint.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Standard of Care Data (routinely collected in clinic)

    Time frame: 10 years

    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.

  2. Research Data: Health Related Quality of Life instrument

    Time frame: 10 years

    • Short Form-36 version 2 (SF-36v2)
  3. Research Data: Health Related Quality of Life instrument

    Time frame: 10 years

    • Oxford 12 Questionnaire
  4. Research Data: Health Related Quality of Life instrument

    Time frame: 10 years

    • Modified Harris Hip Score Questionnaire

Study contacts

Contact information is provided by the study sponsor or research team.

Mia Lundin

CONTACT

[email protected]

720-777-4871

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2019
Primary completion
2050
Study completion
2061
First posted
Mar 4, 2020
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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