Functional Capacity After Computer Assisted Periacetabular Osteotomy in Patients With Hip Dysplasia

NCT02015247 | Completed

• 1 other identifier: Functional capacity PAO
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

Pathogenesis of hip dysplasia Hip dysplasia is multifactorial in origin influenced by genetic and intrauterine factors, such as mechanical (rump presentation and oligohydramnios) and hormonal factors1. To ease the passage through the birth canal, the hip joint is quite mobile perinatally. Postnatally, the laxity of the ligaments will subside and the femoral head will normally position itself deeply in the acetabulum2. The theory is that if the femoral head does not migrate sufficiently into the acetabulum, dysplasia may develop because the matrice to stimulate acetabular growth is not correctly positioned. Normally, at birth the femoral head sits deep in the acetabulum held by surface tension of the synovial liquid. The growth and the hemispherical morphology of acetabulum are dependent on the presence of a normally growing and correctly placed spherical femoral head that works as a convex matrice. If for some reason the normal development is disturbed pre- or postnatally, pathologic relations may develop between the femoral head and the acetabulum3, leading to hip dysplasia. Purpose of this research project is to investigate if the correction of the acetabulum is accurately performed when the surgeon use navigation equipment during PAO.

Conditions

Hip Dysplasia

Outcome Measures

Primary Outcomes (1)

• correction of acetabular fragment in 3D

  position of acetabular fragment measured in three dimensions

  4 months postop

Secondary Outcomes (1)

• functional capacity

  1 year postop

Other Outcomes (1)

• activity

  4 and 12 months postop

Study Arms (1)

computer-assisted surgery

OTHER

use of computer-assisted navigation during periacetabular osteotomy

Procedure: computer-assisted surgery

Interventions

computer-assisted surgery PROCEDURE

use of computer-assisted navigation during periacetabular osteotomy

computer-assisted surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Radiological diagnosed dysplasia (i.e. centre-edge angle \< 25 degrees)
• osteoarthritis degree ≤ 1 according to the criteria of Tonnis
• pain from hip
• minimum 110 degrees flexion in the hip and good rotation
• closed growth zones in the pelvis

You may not qualify if:

• neuromuscular diseases
• previously major hip surgery
• pain in the leg (\>3 on VAS) other than from the hip
• persons with cognitive problems
• persons unable to speak or understand Danish

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Aarhus University Hospital

Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Hip Dislocation

Interventions

Surgery, Computer-Assisted

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Hip Injuries

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Kjeld Søballe, DMSc

  University of Aarhus

  STUDY DIRECTOR

• Inger Mechlenburg, PhD

  University of Aarhus

  PRINCIPAL INVESTIGATOR

• Inger Mechlenburg, PhD

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2013
• First Posted: December 19, 2013
• Study Start: December 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: March 1, 2015
• Last Updated: November 20, 2015

Record last verified: 2013-08

Locations

DK (1)