NCT04590924

Brief Summary

Patients included in the HAFAI cohort will be invited for 5 year follow up.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

September 4, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
10 months until next milestone

First Posted

Study publicly available on registry

October 19, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

July 7, 2021

Status Verified

July 1, 2021

Enrollment Period

1.5 years

First QC Date

September 4, 2019

Last Update Submit

July 5, 2021

Conditions

Outcome Measures

Primary Outcomes (4)

  • Pain 5 years after surgery

    Pain 5 years after surgery measured with the Copenhagen hip and groin scale (0-100 score)

    Score at 5 years and change from before surgery to 5 years after surgery

  • Sports function 5 years after surgery

    Sports function 5 years after surgery measured with the Copenhagen hip and groin scale (0-100 score)

    Score at 5 years and change from before surgery to 5 years after surgery

  • Development of osteoarthritis 5 years after surgery

    Lateral hip joint space width measured at anterior posterior standing radiographs

    Score at 5 years and change from before surgery to 5 years after surgery

  • Re-operation

    Re-operation/total hip replacement

    From date of initial surgery until the date of first documented re-operation or total hip replacement, whichever came first, assessed up to 6 years after initial surgery

Secondary Outcomes (4)

  • Activities of daily living 5 years after surgery

    Score at 5 years and change from before surgery to 5 years after surgery

  • Hip related quality of life 5 years after surgery

    Score at 5 years and change from before surgery to 5 years after surgery

  • Participation in sport 5 years after surgery (HAGOS)

    Score at 5 years and change from before surgery to 5 years after surgery

  • Participation in sport 5 years after surgery (HSAS)

    Score at 5 years and change from before surgery to 5 years after surgery

Interventions

Patients that had hip arthroscopic surgery 5 years ago will be invited for 5 year follow up. The surgical procedures consisted of femoral osteoplasty, labral refixation and acetabular osteoplasty

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients included in the HAFAI cohort 5 years ago.

You may qualify if:

  • Included in the HAFAI cohort

You may not qualify if:

  • Non

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Signe Kierkegaard

Horsens, Danmark, DK-8700, Denmark

Location

Related Publications (1)

  • Kierkegaard S, Mechlenburg I, Dalgas U, Lund B. Five-Year Follow-up After Hip Arthroscopic Surgery in the Horsens-Aarhus Femoroacetabular Impingement (HAFAI) Cohort. Orthop J Sports Med. 2022 Mar 8;10(3):23259671221075653. doi: 10.1177/23259671221075653. eCollection 2022 Mar.

MeSH Terms

Conditions

Femoracetabular Impingement

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Signe Kierkegaard, PhD

    Horsens Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 4, 2019

First Posted

October 19, 2020

Study Start

January 1, 2020

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

July 7, 2021

Record last verified: 2021-07

Locations