A Multi-Centre Study to Test the Safety and Performance of the DePuy AVN Cage in Treating Osteonecrosis of the Hip

Not Applicable

• Conditions: Avascular Necrosis of the Hip; Musculoskeletal - Other muscular and skeletal disorders; Surgery - Other surgery

• Registration Number: ACTRN12612001115820
• Lead Sponsor: DePuy International Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-10-18
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 77

Inclusion Criteria

Skeletally mature
ARCO stage II osteonecrosis of the femoral head

Exclusion Criteria

Acetabular degeneration
Had previous surgery for AVN in the affected hip
Deformity in the upper femur
Drug or alcohol abuse or condition that could affect follow-up
Pregnancy
Nickel or metal sensitivity
Local or systemic infection
Surgical treatment on contralateral hip in last 3 months or planned for within 3 months after surgery
Paget's or Charcot's disease
Osteonecrotic lesion considered to be at limited risk of progression

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ack of disease progression as measured by x-rays, CT & MRI[2 years];No requirement for further surgery[2 years]

Secondary Outcome Measures

Name	Time	Method
Survivorship of the AVN Cage as defined by revision of the AVN Cage for any reason and analysed by Kaplan-Meier plots.[1, 2, 3, 4 and 5 years]