Core Decompression With or Without Cement Packing for ONFH
Core Decompression With or Without Cement Packing for ONFH
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.
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).

 Allocation concealment was practiced with the use of opaque envelopes. Patients with
 bilateral involvement who had been randomized to one treatment modality for one femoral head
 were automatically selected to receive the other treatment modality for the contralateral
 femoral head.

 Blinding of either surgeon or patient is impossible.

 The patients were followed up after surgery every 3-4 months for the first 2 years after
 which the patients were seen annually. Completed questionnaires and radiographs were obtained
 at each visit.

 Statistical Analysis The date of index procedure (CD or CD + PMMA) was used as start date for
 the purpose of statistical analysis. Progression Free Survival was defined as the time to
 radiographic progression and Conversion Free Survival (CFS) as the time to a THA. In case of
 patients who did not have radiographic progression, the date of their last follow up or death
 was used for the analysis. The SAS software will be used for all the analyses. The Log rank
 and Gerhan-Wilcoxon tests were used to compare Kaplan-Meier survival curves for the time from
 the date of the index procedure to radiographic progression (subchondral collapse) or
 conversion to THA for separate groupings based on age at index procedure (<40 , >40 yrs),
 smoking (Y/N), location (central, medial, lateral), percent involvement (<15% [mild], 15% to
 30% [moderate], or >30% [severe]), index of necrotic extent (<40 or >40), and modified index
 of necrotic extent (<40 or >40). Whenever factors were found to affect the survival curves
 mainly in the initial year the Gerhan-Wilcoxon test was used as the test of significance. The
 Kaplan-Meier curves were also compared for the main cohorts of CD vs. CD + PMMA. Cox
 proportional hazards regression was used to compare factors (age, smoking, location, percent
 involvement, index of necrotic extent, and modified index of necrotic extent) with regards to
 their ability to predict the time to progression or revision to THA. Mixed multilevel
 regression modeling was used to test for group differences in the change in self-rated health
 survey scores over time from baseline over the post-operative period. The hierarchical linear
 modeling approach has a number of advantages over traditional repeated measures approaches
 for modeling change over time, including allowance for missing data and for varying
 measurement times across subjects. Separate models were generated for SF-36, Harris Hip Score
 and WOMAC scores over two-year and over 5-year post-operative time periods.
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