NCT05246813

Brief Summary

Bone marrow samples will be collected from patients undergoing hip arthroplasty surgery. Blood and bone marrow samples will be used for metabolic profiling and analysis of relevant CHIP mutations. Combined single-cell transcriptomics and mutation-specific single-cell genotyping (biotin-PCR using mutation-targeted primers followed by sequencing) will subsequently be performed. The gene expression profile of wildtype and mutant hematopoietic stem cells will be compared, performing both broad gene set enrichment analysis and targeted analysis of metabolic pathways.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
56mo left

Started Feb 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress48%
Feb 2022Dec 2030

First Submitted

Initial submission to the registry

February 10, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

February 11, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 18, 2022

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

March 25, 2026

Status Verified

March 1, 2026

Enrollment Period

6.9 years

First QC Date

February 10, 2022

Last Update Submit

March 24, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Gene Set Enrichment Analysis (GSEA) Normalized Enrichment Score (NES)

    One day

Study Arms (2)

Osteoporotic hip fracture patients

Other: Blood and bone marrow cell collection

Hip osteoarthritis patients

Other: Blood and bone marrow cell collection

Interventions

Collection of blood and bone marrow

Hip osteoarthritis patientsOsteoporotic hip fracture patients

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing hip arthroplasty for hip osteoarthritis or osteoporotic hip fractures.

You may qualify if:

  • Age 65 years and older

You may not qualify if:

  • known haematological condition (myelodysplasia, leukemia, cancer)
  • inability to provide written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imelda Hospital

Bonheiden, België, 2820, Belgium

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

EDTA blood and bone marrow samples

MeSH Terms

Conditions

OsteoporosisOsteoarthritis, HipHip Fractures

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesOsteoarthritisArthritisJoint DiseasesRheumatic DiseasesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Nick Van Gastel, PhD

    de Duve Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michaël R. Laurent, MD PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 10, 2022

First Posted

February 18, 2022

Study Start

February 11, 2022

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2030

Last Updated

March 25, 2026

Record last verified: 2026-03

Locations