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

A Prospective, Single-arm, Uncontrolled, Multi-centre Study to Evaluate the Safety and Efficacy of the DePuy AVN Cage Prosthesis for the Treatment of Avascular Necrosis of the Hip.

Status

Terminated

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612001115820

Enrollment

Registered

2012-10-18

Start date

2012-11-06

Completion date

2014-03-05

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of this study is to determine whether the DePuy AVN Cage is a safe and effective treatment for avascular necrosis of the hip in patients for whom the disease has not yet progressed beyond a certain stage. Each surgery will be considered a success if 2 years after surgery the disease has not progressed to the next stage and if the patient has no need for further surgery on that hip.

Interventions

AVN Cage Prosthesis - a metal cage that is inserted into the femoral head and is then packed with bone graft material. Skin to skin time is approximately 45 minutes and the prosthesis is intended to remain in situ permanently.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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

Outcome results