NCT04233125

Core Decompression With or Without Cement Packing for ONFH

Completed Phase 1, PHASE2 Last updated 18 January 2020

What this trial tests

Phase 1, PHASE2 trial testing Core Decompression in Osteonecrosis in 37 participants. Completed in 1 January 2008.

Timeline

1 January 1997

Primary endpoint
1 January 2005

1 January 2008

Quick facts

Lead sponsor	University of Minnesota
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	37
Start date	1 January 1997
Primary completion	1 January 2005
Estimated completion	1 January 2008

Drugs / interventions tested

• Core Decompression
• PMMA augmentation

Conditions studied

• Osteonecrosis — all drugs for Osteonecrosis →

Sponsor

University of Minnesota

Who can join

14 and older, any sex, with Osteonecrosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Osteonecrosis of the femoral head (ONFH) is difficult to treat as collapse frequently occurs after core decompression (CD). This may be due to the failure to provide structural support during revascularization and healing. Reports of polymethylmethacrylate (PMMA) packing of the femoral head after CD for ONFH have noted favorable results. This study was undertaken to determine whether the addition of PMMA packing to CD provides any benefit to progression-free survival (PFS) and conversion to total hip arthroplasty-free survival (CFS). Secondary objectives were to assess for differences in functional outcomes and predictive factors for progression of the disease.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.