Avascular Necrose
Conditions
Interventions
The study procedure will be performed in accordance with the geographical
location
specific surgical technique described in Appendix 2 and in accordance with the
geographical location specific Manu
Sponsors
Biomet Biologics (Zimmer Biomet)
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Physician agrees that patient is good candidate for procedure - At least 18 years of age - Willing and able to comply with the study procedures - Signed informed consent form - If bilateral untreated AVN, eligible and willing to undergo study treatment and follow-up for both hips - If contralateral hip has undergone a THA surgery, 3 months of time must have passed since THA before performing the study procedure
Exclusion criteria
Exclusion criteria: - Pregnant or lactating - Participating in another device or drug study - AVN stage (ARCO) * 3 - Unable to undergo MRI of the study hip(s) - Active or chronic infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients achieving clinical success at 12 months after initial study procedure. For the purpose of the study, clinical success is defined as an increase of HHS of more than 20 points from baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Number of patients with no change or decrease in lesion size measured via MRI at 12 months after the index procedure compared to baseline - Number of hip collapses requiring an invasive procedure other than study treatment - Measure the number of adverse events of interest at 3, 6, 12, 24, 36, 48 and 60 months after the index procedure - Change in HHS, pain measured with the NRS and quality of life scores measured with EQ-5D-3L 3, 6, 12, 24, 36, 48, and 60 months after the index procedure - Number of patients with *good* or *excellent* HHS at all post-operative time points - Cost of healthcare associated with AVN treatment - Number of study procedures per patient | — |
Countries
Netherlands
Outcome results
None listed