NCT03490071

Brief Summary

In this longitudinal cohort study including young to middle aged people with longstanding hip and groin pain (LHGP) referred to tertiary care, we will collect data of patient reported symptoms, function and quality of life three and seven years after the initial contact with orthopedic surgeon.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

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

Study Start

First participant enrolled

January 1, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 6, 2018

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

April 15, 2026

Status Verified

February 1, 2024

Enrollment Period

6.2 years

First QC Date

March 28, 2018

Last Update Submit

April 10, 2026

Conditions

Keywords

Longstanding hip and groin painPatient reported outcome

Outcome Measures

Primary Outcomes (1)

  • Changes in the Copenhagen Hip and Groin Outcome Score (HAGOS)

    Patient reported outcome regarding hip dysfunction, which includes six subscales; pain, symptoms, physical function in daily living, physical function in sport and recreation, participation in physical activity, and quality of life. The score for each subscale ranges from 0-100, where 0 indicates extreme problems and 100 no problems. Patient Acceptable Symptom State (PASS) will be derived from HAGOS score using previously described cut-off values for the different subscales

    3 and 7 years after baseline (cross-sectional study)

Secondary Outcomes (6)

  • HSAS - Hip Sports Activity Scale (HSAS)

    3 and 7 years after baseline (cross-sectional study)

  • K-10 questionnaire

    3 years after baseline (cross-sectional study)

  • Self-Presentation in Exercise Questionnaire (SPEQ)

    3 years after baseline (cross-sectional study)

  • The Multidimensional Scale of Perceived Social Support (MSPSS)

    3 years after baseline (cross-sectional study)

  • Medical Outcomes Study short form 36 (SF-36)

    3 and 7 years after baseline (cross-sectional study)

  • +1 more secondary outcomes

Other Outcomes (1)

  • Imaging

    7 years after baseline

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients will be recruited from the Department of Orthopedics, Skåne University Hospital, Sweden.

You may not qualify if:

  • Unilateral or bilateral hip/groin pain \>3 months
  • Age 18-55 years
  • No previous hip surgery
  • Hip pathology (i.e., Perthes' disease)
  • Verified moderate or severe osteoarthritis (OA) (Tönnis grade \>1)
  • Palpable hernia
  • Low-back pain with a positive Lasègue test
  • MRI-verified lower back/spine pathology (i.e., spinal stenosis, disc herniation)
  • Other musculoskeletal co-morbidities overriding the hip-related symptoms and dysfunction
  • Co-morbidities excluding physical activity and training
  • Psycho-social disorders
  • Drug abuse
  • Not understanding the language of interest.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Health Sciences, Lund University

Lund, 22100, Sweden

Location

Study Officials

  • Eva Ageberg, PhD

    Lund University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2018

First Posted

April 6, 2018

Study Start

January 1, 2018

Primary Completion

March 1, 2024

Study Completion

December 31, 2024

Last Updated

April 15, 2026

Record last verified: 2024-02

Locations