NCT01344421

Brief Summary

The purpose of this study is to examine the movement pattern in patients with hip dysplasia preoperative, six and 12 month after minimally invasive approach for Periacetabular osteotomy (PAO). Secondary to examine the movement pattern in patients compared to healthy controls and historical data.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2011

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

March 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 29, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

April 5, 2013

Status Verified

April 1, 2013

Enrollment Period

2 years

First QC Date

April 27, 2011

Last Update Submit

April 4, 2013

Conditions

Keywords

Movement capture systemMovement analysisHip dysplasiaHip painQuality of lifePhysical function

Outcome Measures

Primary Outcomes (1)

  • Hip flexion's muscle moment in stance evaluated in gait, run and jump test

    Examined using 3D Movement Capture System

    Preoperative (baseline), 6 and 12 month postoperative

Secondary Outcomes (4)

  • Hip extension angle evaluated in gait, run and jump test

    Preoperative (baseline), 6 and 12 month postoperative

  • On-set of the hip muscles evaluated in gait, run and jump test

    Preoperative (baseline), 6 and 12 month postoperative

  • Function, sports and recreational activities

    Preoperative (baseline), 6 and 12 month postoperative

  • Quality of life

    preoperative (baseline), 6 and 12 month postoperative

Study Arms (2)

hip dysplasia

Patients with hip dysplasia

Procedure: Minimally invasive approach for Periacetabular osteotomy

Healthy people

Enrolled from the patients acquaintance circle

Interventions

A peri-acetabular osteotomy is a surgery performed to correct the dysplastic acetabulum and reduce joint contact pressures and early osteoarthritis.

Also known as: PAO (periacetabular osteotomy)
hip dysplasia

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with hip dysplasia and waiting for surgery.

You may qualify if:

  • Patients diagnosed with hip dysplasia
  • Patients in the age of 18-60 years
  • Patients, who can speak, understand and read Danish

You may not qualify if:

  • Persons with hip dysplasia secondary to other hip conditions such as Calvé Perthes and epiphysiolysis.
  • Persons who have had alloplastic surgery in the hip, knee or ankle.
  • Persons with diseases that affect the gait pattern.
  • Persons with serious hip, knee, ankle or back pain.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Related Publications (1)

  • Sorensen H, Skalshoi O, Nielsen DB, Jacobsen JS, Soballe K, Mechlenburg I. Hip muscle and joint contact forces before, 6 and 12 months after minimally invasive periacetabular osteotomy. Hip Int. 2021 Sep;31(5):676-682. doi: 10.1177/1120700020925411. Epub 2020 May 4.

MeSH Terms

Conditions

Hip Dislocation

Interventions

Polyamine Oxidase

Condition Hierarchy (Ancestors)

Joint DislocationsJoint DiseasesMusculoskeletal DiseasesWounds and InjuriesHip Injuries

Intervention Hierarchy (Ancestors)

Oxidoreductases Acting on CH-NH Group DonorsOxidoreductasesEnzymesEnzymes and Coenzymes

Study Officials

  • Julie S Jacobsen, MSc

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR
  • Inger Mechlenburg, MSc, PhD

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR
  • Kjeld Søballe, Prof. Dr.med

    Aarhus University Hospital

    STUDY CHAIR
  • Henrik Sørensen, PhD

    University of Aarhus

    STUDY CHAIR
  • Dennis Nielsen, MSc

    University of Aarhus

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

April 27, 2011

First Posted

April 29, 2011

Study Start

March 1, 2011

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

April 5, 2013

Record last verified: 2013-04

Locations