Does Adjunction of Autologous Osteoblastic Cells Improve the Results of Core Decompression in Early-stage Femoral Head Osteonecrosis? A Double-blind, Randomized Trial.
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SUBMITTER: Jayankura M
PROVIDER: S-EPMC10344543 | biostudies-literature | 2023 Aug
REPOSITORIES: biostudies-literature
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Does Adjunction of Autologous Osteoblastic Cells Improve the Results of Core Decompression in Early-stage Femoral Head Osteonecrosis? A Double-blind, Randomized Trial.
Jayankura Marc M Thomas Thierry T Seefried Lothar L Dubrana Frederic F Günther Klaus-Peter KP Rondia Jean J Davis Edward T ET Winnock de Grave Philip P Carron Philippe P Gangji Valérie V Vande Berg Bruno B Godeaux Olivier O Sonnet Wendy W
Clinical orthopaedics and related research 20230324 8
<h4>Background</h4>Osteonecrosis of the femoral head (ONFH) is a disabling disease that can ultimately progress to collapse of the femoral head, often resulting in THA. Core decompression of the femoral head combined with cell therapies have shown beneficial effects in previous clinical studies in patients with early-stage (Association Research Circulation Osseous [ARCO] Stage I and II) ONFH. However, high-quality evidence confirming the efficacy of this treatment modality is still lacking.<h4>Q ...[more]
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Project description:The management of pre-collapse osteonecrosis of the femoral head is controversial. Core decompression is a technique that theoretically decreases the intraosseous pressure of the femoral head, resulting in a local vascularized healing response. Its efficacy has been shown in delaying early subchondral collapse. We describe the technique of arthroscopic-assisted core decompression of the femoral head for osteonecrosis. The advantages of this technique include evaluation of the presence or absence of articular cartilage injury, subchondral collapse, and guidance during reaming and curettage. It also allows the ability to address any concomitant soft-tissue or bony pathology associated with or in addition to the osteonecrotic lesion.
| S-EPMC3986482 | biostudies-literature
Project description:ObjectiveFemoral head necrosis (FHN) affects mostly young and active people. The most common operative therapy is core decompression (CD) with optional cancellous bone grafting (CBG). Because little information is available on the long-term results of these procedures, we investigated the effectiveness of CD and CD + CBG in patients with ARCO stage II FHN in terms of postoperative pain, range of motion, patient-reported outcome measures (Harris Hip Score, Hip Disability and Osteoarthritis Outcome Score, EuroQol 5D, and Short Form 36 Questionnaire), and disease progression.MethodsWe retrospectively compared 11 patients treated with CD alone 48.0 months (range, 26.3-68.5 months) postoperatively versus 11 patients treated with CD + CBG 69.2 months (range, 38.0-92.9 months) postoperatively. All patients were assessed according to a routine clinical protocol involving a clinical examination, questionnaires, and radiological imaging (X-ray and magnetic resonance imaging).ResultsThe clinical and radiological results showed no significant differences between the two groups. Both interventions demonstrated equal results according to clinical scores.ConclusionsOur data may encourage application of the less invasive technique of CD alone without CBG, which is more surgically demanding. Further prospective studies with longer follow-up are necessary to clarify the risk factors for therapy failure.
| S-EPMC10416661 | biostudies-literature
Project description:BackgroundMinimally invasive treatment options for osteonecrosis of the femoral head (ONFH) have been a prominent area of research in recent years. Arthroscopic-assisted treatments have been applied in the clinical management of ONFH; however, high-quality evidence verifying their effectiveness and safety is still lacking.ObjectiveTo systematically assess the clinical efficacy and safety of arthroscopic-assisted core decompression (AACD) in treating ONFH.MethodsA comprehensive literature search was conducted in PubMed, Web of Science, EMBASE, Cochrane Library, Chinese National Knowledge Infrastructure, China Science and Technology Journal Database, WanFang, and the Chinese BioMedical Literature Database, from inception to June 25, 2024. We identified randomized controlled trials and non-randomized controlled studies on AACD for the treatment of ONFH based on predefined inclusion and exclusion criteria. A meta-analysis was performed using Review Manager 5.4.1 and Stata 17.0 software. The analyzed outcomes included operative time, intraoperative blood loss, length of hospital stay, postoperative femoral head collapse rate, Harris hip score, and postoperative complication rate. The Grades of Recommendations, Assessment, Development, and Evaluations (GRADE) system was used to assess the quality of evidence for the outcome indicators.ResultsA total of fourteen studies were included in this meta-analysis, comprising 1,063 patients-541 in the core decompression (CD) group and 522 in the AACD group. The meta-analysis revealed no significant differences between the two groups in terms of intraoperative blood loss, length of hospital stay, 12-month postoperative Harris hip score, or overall postoperative complication rate (P > 0.05). However, the AACD group had a longer operative time (MD = 31.19, 95% Cl: 5.32 to 57.07, P = 0.02) and a lower overall postoperative femoral head collapse rate (RR = 0.49, 95% Cl: 0.27 to 0.89, P = 0.02) compared with the CD group. Additionally, the AACD group showed significant improvements in Harris hip scores at 3 months (MD = 6.39, 95% Cl: 5.44 to 7.33, P < 0.00001), 6 months (MD = 7.56, 95% Cl: 6.63 to 8.49, P < 0.00001), ≥ 24 months (MD = 7.00, 95% Cl: 4.80 to 9.21, P < 0.00001), and at the last follow-up (MD = 6.89, 95% Cl: 5.30 to 8.48, P < 0.00001) compared to the CD group. The GRADE evidence assessment indicated that the overall postoperative complication rate was supported by moderate-quality evidence, while the evidence for operative time, intraoperative blood loss, postoperative femoral head collapse rate, and Harris hip score was of low quality. The evidence for length of hospital stay was deemed very low quality.ConclusionThis meta-analysis suggests that AACD is an effective and safe treatment for patients with ONFH. However, due to the limited quantity and quality of the included studies, these results should be interpreted with caution. Further high-quality studies are recommended to confirm these findings.
| S-EPMC11567543 | biostudies-literature
Project description:PurposeCore decompression (CD) of the femoral head is performed to preserve the hip in avascular necrosis (AVN). The outcome following this procedure differs based on the medical centre and the technique. Also, the time to total hip replacement (THR) and the percentage of patients subsequently undergoing a THR are controversial.MethodsA systematic review was performed following PRISMA guidelines. The search included CENTRAL, MEDLINE, EMBASE, Scopus, AMED and Web of Science Core Collection databases. Studies reporting the outcome of CD for AVN were assessed. Studies using additional implants, vascularized grafts or any type of augmentation were excluded. Quality assessment was performed using the Joanna Briggs Institute Critical Appraisal Checklist (JBI CAC) tool.Trial registrationInternational prospective register of systematic reviews (PROSPERO) - CRD42018100596 .ResultsA total of 49 studies describing 2540 hips were included. The mean weighted follow-up time was 75.1 months and the mean age at surgery was 39 years. Twenty-four of 37 studies reported improvement in all outcome scores, whilst 9/37 studies report only partial improvement post-operatively. Four studies (4/37) described poor clinical outcomes following intervention. Data was pooled from 20 studies, including 1134 hips with a weighted mean follow-up of 56 months. The percentage of hips undergoing THR averaged 38%. The time to THR had a weighted mean of 26 months after CD.ConclusionPooled results from 1134 hips and of these nearly 80% with early stage of osteonecrosis, showed that approximately 38% of patients underwent a total hip replacement at an average of 26 months following core decompression without augmentation.
| S-EPMC7892522 | biostudies-literature
Project description:Lack of necessary perfusion to the femoral head can lead to necrosis of the underlying bone (avascular necrosis) and result in femoral and acetabular surface changes in advanced stages. Numerous treatments have been reported in the literature, including nonoperative and surgical procedures. In addition to the standard core decompression, we describe the use of bone marrow aspirate to stimulate a healing response and bone grafting, allowing for immediate weight bearing postoperatively. The purpose of this article was to describe our method of core decompression augmented with bone marrow aspirate concentrate and bone grafting for the treatment of early avascular necrosis of the femoral head.
| S-EPMC5021452 | biostudies-literature
Project description:BackgroundIn patients with nontraumatic osteonecrosis of the femoral head (ONFH), implantation of bone marrow aspirate concentrate (BMAC) could delay the progression of osteonecrosis and improve symptoms in pre-fracture ONFH. However, the BMAC content, especially in osteoblastic stem cells, could have an important individual variability. An autologous osteoblastic cell product could improve the effect of such cell-based therapy.Questions/purposes(1) Does autologous osteoblastic cell therapy decrease the likelihood of progression to subchondral fracture with or without early collapse corresponding to Association Research Circulation Osseous (ARCO) classification Stage III or higher, and provide a clinically important pain improvement compared with BMAC treatment alone? (2) Were patients treated with osteoblastic cell therapy less likely to undergo subsequent THA? (3) What proportion of patients in the treatment and control groups experienced adverse events after surgery?MethodsBetween 2004 and 2011, we treated 279 patients for Stage I to II hip osteonecrosis (ON) with surgery. During that time, our general indications for surgery in this setting included non-fracture ON lesions. To be eligible for this randomized, single-blind trial, patients needed to have an ONFH Stage I or II; we excluded those with traumatic ONFH, hemoglobinopathies and positive serology for hepatitis B, C or HIV. Of those treated surgically for this diagnosis during the study period, 24% (67) agreed to participate in this randomized trial. Hips with pre-fracture ONFH were randomly treated with a core decompression procedure associated with either implantation of a BMAC (BMAC group; n = 26) or osteoblastic cell (osteoblastic cell group; n = 30). The groups were not different in terms of clinical and imaging characteristics. The primary study outcome was treatment response, defined as the absence of progression to subchondral fracture stage (ARCO stage III or higher) plus a clinically important pain improvement defined as 1 cm on a 10-cm VAS. The secondary endpoint of interest was the frequency in each group of subsequent THA and the frequency of adverse events. The follow-up duration was 36 months. We used an as-treated analysis (rather than intention-to-treat) for our efficacy endpoint, and an intention-to-treat analysis for adverse events. Overall, 26 of 26 patients in the BMAC group and 27 of 30 in the osteoblastic cell group completed the trial.ResultsAt 36 months, no clinically important differences were found in any study endpoint. There was no difference in the proportion of patients who had progressed to fracture (ARCO stage III or higher; 46% of the BMAC hips [12 of 26] versus 22% in the hips with osteoblastic cells [six of 27], hazard ratio, 0.47 [95% CI 0.17 to 1.31]; p = 0.15). There was no clinically important difference in VAS pain scores. No differences were found for either the WOMAC or the Lequesne indexes. With the numbers available, there was no difference in the proportion of patients in the groups who underwent THA at 36 months 15% (four of 27) with osteoblastic cells versus 35% (nine of 26) with BMAC; p = 0.09 With the numbers available, we found no differences between the treatment and control groups in terms of the frequencies of major adverse events.ConclusionsWe found no benefit to osteoblastic cells over BMAC in patients with pre-collapse ONFH; side effects were uncommon and generally mild in both groups. This study could be used as pilot data to help determine sample sizes for larger (presumably multicenter) randomized controlled trials. However, this novel treatment cannot be recommended in routine practice until future, larger studies demonstrate efficacy.Level of evidenceLevel II, therapeutic study.
| S-EPMC7319372 | biostudies-literature
Project description:Core decompression is a joint-preserving surgery feasible in early-stage avascular necrosis of the femoral head. An arthroscopically/endoscopically aided development of this procedure is presented to overcome some drawbacks of the standard technique. Conventional imaging may underestimate the articular damage; thus a preliminary hip arthroscopy helps to identify those patients with significant joint damage, who might not benefit from the procedure. The standard fluoroscopically guided core decompression does not allow precise targeting or reliable debridement of the lesion. Tunnel endoscopy helps the surgeon to aim precisely at the lesion and to debride it thoroughly, with accurate visual verification. In conclusion, the arthroscopic-endoscopic assistance may lead to more accurate patient selection, more precise targeting, and more complete debridement, with no apparent disadvantages.
| S-EPMC3678640 | biostudies-literature
Project description:Core decompression procedures have been used in osteonecrosis of the femoral head to attempt to delay the joint destruction that may necessitate hip arthroplasty. The efficacy of core decompressions has been variable with many variations of technique described. To determine whether the efficacy of this procedure has improved during the last 15 years using modern techniques, we compared recently reported radiographic and clinical success rates to results of surgeries performed before 1992. Additionally, we evaluated the outcomes of our cohort of 52 patients (79 hips) who were treated with multiple small-diameter drillings. There was a decrease in the proportion of patients undergoing additional surgeries and an increase in radiographic success when comparing pre-1992 results to patients treated in the last 15 years. However, there were fewer Stage III hips in the more recent reports, suggesting that patient selection was an important reason for this improvement. The results of the small-diameter drilling cohort were similar to other recent reports. Patients who had small lesions and were Ficat Stage I had the best results with 79% showing no radiographic progression. Our study confirms core decompression is a safe and effective procedure for treating early stage femoral head osteonecrosis.
| S-EPMC2311489 | biostudies-other
Project description:BACKGROUND:Osteonecrosis of the femoral head (ONFH) is a frequent orthopedic disease leading to destruction of the hip joint and disabling arthritis. Several procedures have been developed to treat the joint deterioration in case of osteonecrosis, trying to avoid or delay an intervention of total hip replacement, especially in young patients. The aim of this study was to analyze the use of autologous bone micrografts derived from cancellous bone in the management of avascular ONFH. The treatment described was implemented using the Rigenera® protocol to obtain autologous micrografts: small fragments of cancellous bone collected by femoral neck, disaggregated and injected in the necrotic area using an empty screw. MATERIALS AND METHODS:Twenty adult patients affected by avascular ONFH were enrolled in this study; all patients reported a preoperative intermittent coxo-arthrosis and limited function of intra and extra rotation of the hip. Inclusion criteria were an Oxford Hip Score between (OHS) 20 and 39, a Harris hip score (HHS) showing pre-operative poor results (lower than 70 points) and a stage II-IIIA and IIIB according with the classification proposed by the Association Research Circulation Osseous (ARCO). RESULTS:Using an MRI evaluation, after six months, the authors observed a complete regression of necrotic area and the restoration of osseous structure. Clinical outcome has been evaluated at 6-12 and 24 months follow-up. At the final F.U. the HHS rised from poor to good results (mean value at final F.U of 84) while the OHS improved significantly already after 21 days from micrografts injection (mean 35.4 ± 7.5) with an increasing trend until to two-year final FU (mean 37.4 ± 9.5). The full recovery of daily and mild sport activities was reached after 20 and 90 days from intervention, respectively. CONCLUSION:The results of this study are suggestive for a new approach in the treatment of avascular ONFH assuming a process of bone regeneration based on a dual mechanism of action, biological and mechanical, induced by micrografts and injected using an empty screw as vehicle.
| S-EPMC7569645 | biostudies-literature
Project description:BACKGROUND:Core decompression is a common surgical technique to treat osteonecrosis of the femoral head. The aim of this study is to evaluate the effect of the parameters "age" and "sex" on the outcome of this type of treatment. METHODS:A prospective cohort study was performed. Eighty-six osteonecrotic hips with a mean follow-up of 32.5?months (± 24.8) after advanced core decompression were analysed regarding age- and sex-dependent treatment failure. Additionally, the modified Harris Hip Score and Numeric Rating Scale were compared regarding the parameters age and sex. RESULTS:The mean hip survival of the male participants was 51.3?months (39.4% treatment failure), whereas females presented a longer, thus not significant, mean survival of 61.4?months (30% therapy failure; p = 0.48). The further evaluation revealed significantly better survival in the patients aged < 40?years (mean survival 66.09?months, 16% treatment failure) in comparison to those aged ? 40?years (mean survival 50.14?months, 46% therapy failure; p = 0.03). The modified Harris Hip Score and Numeric Rating Scale results of patients whose treatment did not fail during the study period were similar, irrespective of the patient's sex or age. CONCLUSIONS:The study shows that the number of therapy failures is significantly higher in older patients, with 40?years of age marking the borderline. Patients' sex does not seem to affect the outcome of treatment, and postoperative clinical scores appear to be identical with individuals not affected by therapy failure. Since age and sex are unalterable parameters, the study helps to provide valuable predictions regarding the chances of long-term hip survival after treatment of osteonecrosis.
| S-EPMC7110716 | biostudies-literature