NCT05265858

Brief Summary

This prospective longitudinal cohort study aims (1) to identify clinical phenotypes in persons with hip osteoarthritis and after total hip arthroplasty, and (2) to identify prognostic factors for outcomes after total hip arthroplasty.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2021

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

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 Start

First participant enrolled

May 4, 2021

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 9, 2022

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 4, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

March 4, 2022

Status Verified

February 1, 2022

Enrollment Period

2.7 years

First QC Date

February 9, 2022

Last Update Submit

February 22, 2022

Conditions

Hip OsteoarthritisTotal Hip Arthroplasty

Keywords

Hip OsteoarthritisTotal Hip ArthroplastyPrognostic factorsPainDisabilityPsychotraumatic eventsFear-AvoidanceSelf-efficacyPerceived InjusticeQuantitative Sensory TestingClinical phenotypePsychopathology

Outcome Measures

Primary Outcomes (4)

  • Hip disability and Osteoarthritis Outcome Score (HOOS)

    The HOOS is a self-reported questionnaire for evaluating symptoms and disability in patients with hip complaints. The questionnaire has been validated in Dutch and consists of 40 items, divided into five subscales: symptoms (5 items), pain (10 items), functioning in activities of daily living (ADL)(17 items), functioning in sport and recreation (4 items), and quality of life (4 items). Each question is scored on a 5-point Likert scale, in which a higher score reflects fewer complaints. A normalized score from 0 to 100 is calculated for the total scale, and for each subscale individually.

    1 week before THA

  • Hip disability and Osteoarthritis Outcome Score (HOOS)

    The HOOS is a self-reported questionnaire for evaluating symptoms and disability in patients with hip complaints. The questionnaire has been validated in Dutch and consists of 40 items, divided into five subscales: symptoms (5 items), pain (10 items), functioning in activities of daily living (ADL)(17 items), functioning in sport and recreation (4 items), and quality of life (4 items). Each question is scored on a 5-point Likert scale, in which a higher score reflects fewer complaints. A normalized score from 0 to 100 is calculated for the total scale, and for each subscale individually.

    6 weeks after THA

  • Hip disability and Osteoarthritis Outcome Score (HOOS)

    The HOOS is a self-reported questionnaire for evaluating symptoms and disability in patients with hip complaints. The questionnaire has been validated in Dutch and consists of 40 items, divided into five subscales: symptoms (5 items), pain (10 items), functioning in activities of daily living (ADL)(17 items), functioning in sport and recreation (4 items), and quality of life (4 items). Each question is scored on a 5-point Likert scale, in which a higher score reflects fewer complaints. A normalized score from 0 to 100 is calculated for the total scale, and for each subscale individually.

    3 months after THA

  • Hip disability and Osteoarthritis Outcome Score (HOOS)

    The HOOS is a self-reported questionnaire for evaluating symptoms and disability in patients with hip complaints. The questionnaire has been validated in Dutch and consists of 40 items, divided into five subscales: symptoms (5 items), pain (10 items), functioning in activities of daily living (ADL)(17 items), functioning in sport and recreation (4 items), and quality of life (4 items). Each question is scored on a 5-point Likert scale, in which a higher score reflects fewer complaints. A normalized score from 0 to 100 is calculated for the total scale, and for each subscale individually.

    12 months after THA

Secondary Outcomes (42)

  • Patient Specific Functional Scale (PSFS)

    1 week before THA

  • Patient Specific Functional Scale (PSFS)

    6 weeks after THA

  • Patient Specific Functional Scale (PSFS)

    3 months after THA

  • Patient Specific Functional Scale (PSFS)

    12 months after THA

  • 36-Item Short Form Health Survey (SF-36)

    1 week before THA

  • +37 more secondary outcomes

Other Outcomes (58)

  • Thermal Detection and Pain Threshold Temperatures

    1 week before THA

  • Thermal Detection and Pain Threshold Temperatures

    6 weeks after THA

  • Thermal Detection and Pain Threshold Temperatures

    3 months after THA

  • +55 more other outcomes

Study Arms (1)

Patients with hip osteoarthritis

Patients with hip osteoarthritis who will undergo total hip arthroplasty

Procedure: Total Hip Arthroplasty

Interventions

Total Hip ArthroplastyPROCEDURE

Direct Anterior Approach (DAA) Total Hip Arthroplasty (THA)

Patients with hip osteoarthritis

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Persons with hip osteoarthritis who will undergo THA

You may qualify if:

  • Persons with a confirmed clinical or radiographic primary diagnosis of hip osteoarthritis who will undergo total hip arthroplasty (THA)

You may not qualify if:

  • Rheumatoid arthritis or other rheumatic diseases
  • Another pathological condition explaining the symptoms (e.g. avascular necrosis)
  • Neurological condition (e.g. Parkinson's disease, stroke...) significantly influencing the symptoms of hip osteoarthritis.
  • Revision THA
  • History of pathological fractures (e.g. osteoporosis, tumor...)
  • Contralateral THA during follow-up period
  • Total knee arthroplasty (TKA) during follow-up period
  • Another surgery planned during follow-up period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Heuppraktijk

Herselt, Antwerpen, 2230, Belgium

RECRUITING

Ziekenhuis Oost-Limburg

Genk, Limburg, 3600, Belgium

RECRUITING

Related Publications (2)

  • Sergooris A, Verbrugghe J, Bonnechere B, Matheve T, Corten K, Bogaerts K, Timmermans A. Inter-individual differences in early post-operative pain, cognitions, and emotions after total hip arthroplasty: A longitudinal cohort study. Clin Rehabil. 2025 Jun;39(6):784-795. doi: 10.1177/02692155251333537. Epub 2025 Apr 21.

    PMID: 40255065DERIVED

  • Sergooris A, Verbrugghe J, Matheve T, Van Den Houte M, Bonnechere B, Corten K, Bogaerts K, Timmermans A. Clinical phenotypes and prognostic factors in persons with hip osteoarthritis undergoing total hip arthroplasty: protocol for a longitudinal prospective cohort study (HIPPROCLIPS). BMC Musculoskelet Disord. 2023 Mar 25;24(1):224. doi: 10.1186/s12891-023-06326-9.

    PMID: 36964541DERIVED

MeSH Terms

Conditions

Osteoarthritis, HipPain

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Annick Timmermans

    Hasselt University

    PRINCIPAL INVESTIGATOR

  • Kristoff Corten

    Ziekenhuis Oost-Limburg

    PRINCIPAL INVESTIGATOR

  • Katleen Bogaerts

    Hasselt University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Abner Sergooris

CONTACT

003211299187abner.sergooris@uhasselt.be

Annick Timmermans

CONTACT

003211292125annick.timmermans@uhasselt.be

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 9, 2022

First Posted

March 4, 2022

Study Start

May 4, 2021

Primary Completion

February 1, 2024

Study Completion

February 1, 2024

Last Updated

March 4, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

BE(2)