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Core Decompression With or Without Cement Packing for ONFH

NCT04233125 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2020-01-18

No results posted yet for this study

Summary

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.

Conditions

  • Osteonecrosis

Interventions

PROCEDURE

Core Decompression

Core Decompression

PROCEDURE

PMMA augmentation

Polymethylmethacrylate (PMMA) augmentation

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1997-01-01
Primary Completion
2005-01-01
Completion
2008-01-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04233125 on ClinicalTrials.gov