A Randomized Controlled Trial of Core Decompression With or Without Cement Packing for Osteonecrosis of the Femoral Head - Long Term Results
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- University of Minnesota
- Enrollment
- 37
- Primary Endpoint
- Progression Free Survival (PFS)
Study Overview
Brief 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.
Detailed Description
A prospective randomized controlled trial comparing the results of CD vs. CD + PMMA packing in pre-collapse ONFH was set up.
Consecutive symptomatic patients aged >14 years with Association Research Circulation Osseous (ARCO) Stage I and II ONFH diagnosed using MRI and radiographic imaging were enrolled in this study.
Exclusion criteria were pre-existing collapse, sub-chondral fracture or degenerative changes of the hip.
After obtaining informed written consent, patients are asked to complete the Harris Hip Score (HHS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and a health status questionnaire Short Form-36 (SF-36).
The femoral heads enrolled into the study are randomized using a computer-generated card draw system to one of following: core decompression (CD) or core decompression with PMMA cement packing (CD + PMMA).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 14 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Association Research Circulation Osseous (ARCO) Stage I and II ONFH diagnosed using MRI and radiographic imaging
Exclusion Criteria
- •pre-existing collapse, subchondral fracture or degenerative changes of the hip
Arms & Interventions
Core Decompression (CD) Only
Participants in this group receive standard care
Intervention: Core Decompression (Procedure)
Added Polymethylmethacrylate (PMMA)
Participants in this group receive standard care with an additional treatment
Intervention: Core Decompression (Procedure)
Added Polymethylmethacrylate (PMMA)
Participants in this group receive standard care with an additional treatment
Intervention: PMMA augmentation (Procedure)
Outcomes
Primary Outcomes
Progression Free Survival (PFS)
Time Frame: 5 years
Progression Free Survival (PFS) is defined as the length of time (reported in months) following surgery that participants have no signs of radiographic progression of femoral head osteonecrosis. Radiographic progression is defined as any degree of flattening or loss of spherical contour of the femoral head as detected on the radiographs or MRI. Appearance of a subchondral fracture (crescent sign) on radiographs or MRI was also considered a sign of progression.
Secondary Outcomes
- Change in Harris Hip Score (HHS)(baseline, 2 years post surgery)
- Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)(baseline, 2 years post surgery)
- Conversion Free Survival (CFS)(5 years)
- Change in Short Form-36 (SF-36)(baseline, 2 years post surgery)
- Mean Harris Hip Score (HHS)(baseline, 2 years post surgery, 5 years post surgery)
- Mean Short Form-36 (SF-36)(baseline, 2 years post surgery, 5 years post surgery)
- Mean Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)(baseline, 2 years post surgery, 5 years post surgery)