Cell therapy for post-traumatic hip osteonecrosis in young patients.

PURPOSE: To investigate the effects of mesenchymal stem cells injections for treatment of post-traumatic osteonecrosis of the femoral head. METHODS: A total of 46 patients were eligible and enrolled in the study. Twenty-three patients were treated with cell therapy and 23 patients with hip arthroplasty (control group). During a minimum follow-up duration of 10years, radiographs were used to evaluate the radiological results, and the Harris Hip Score (HHS) and visual analog scale were chosen to assess the clinical results. RESULTS: For the cell therapy group, the product obtained by bone marrow aspiration in the iliac crest before concentration had a mean value of 2480 MSCs/mL (range 730 to 3800). The concentration product was containing average 9300 MSCs/mL (range 3930 to 19,800). At the most recent follow-up (average 15years after the first surgery, range 10 to 20years), among the 23 hips treated with cell therapy (concentrate bone marrow), 6 hips (26%) had collapsed and had required total hip arthroplasty (THA) without revision. Among the 23 hips treated with a primary THA, 7 (30.4%) had required one revision (second THA) at a mean follow-up of 6years (range 1 to 12years); two of these 7 hips had a re-revision; principal causes of revision were recurrent dislocations (3 cases) aseptic loosening (3 revisions) and infection (1 revision). As consequence, we observed significant (P<0.01) better survival time before revision for the cell therapy group. Better results with cell therapy were obtained for treatment at early stages before collapse. CONCLUSION: The present study has demonstrated encouraging effects of cell therapy in early post-traumatic hip osteonecrosis and provides another choice for treatment in early stages I to II.

Cell therapy for posttraumatic shoulder osteonecrosis.

PURPOSE: This study compared the clinical and radiological results of bone marrow mesenchymal stem cell implantation with traditional simple core decompression (CD) using a matched pair case-control design for osteonecrosis of the humeral head (ONHH) after fracture of the proximal humerus. PATIENTS: We retrospectively reviewed 64 patients who had surgery for ONHH. Thirty patients had been treated with cell therapy between 2010 and October 2015, with 18 patients at pre-collapse stage (8 stages-I, 10 stages-II), and 12 patients at post-collapse stages (7 stages-III and 5 stages-IV). Using a matched pair case-control design, these 30 study patients were compared to 34 other patients who were treated with simple core decompression (CD) without cells (control group). METHODS: The cell therapy group was treated with percutaneous mesenchymal cell (MSCs) injection obtained from bone marrow (BM) concentration. During a mean follow-up duration of 7years (5 to 10years), radiographs performed each year were used to evaluate the radiological results; the Constant score and visual analogue scale were chosen to assess the clinical results. We assessed stage progression, collapse and arthroplasty conversion rate. Survivor rate analysis was performed using these parameters as the primary endpoints. RESULTS: Among the 30 shoulders included in the cell therapy group, three (10%) humeral heads had collapsed at the most recent follow-up, versus 25 (74%) in 34 shoulders after simple core decompression (P<0.0001). As consequence, we observed statistically significant difference (P=0.0001) in the humeral head survival (absence of arthroplasty conversion) rate at the end time point between the cell therapy group (93% survival) and simple core decompression (26% survival). Better results were obtained for early stages (stages I and II) osteonecrosis without collapse at baseline. CONCLUSION: Core decompression with cell therapy was a safe and effective procedure for treatment in the pre-collapse stages of posttraumatic shoulder osteonecrosis and improved the outcome of the disease as compared with simple core decompression without cells.

Single-use versus reusable medical devices in spinal fusion surgery: a hospital micro-costing analysis.

PURPOSE: Healthcare facilities could minimize the cost of surgical instrument and implant processing by using single-use devices. The main objective was to prospectively compare the total cost of a single-use and reusable device used in short lumbar spine fusion. METHODS: A 1-year, single-centre, prospective study was performed on patients requiring a one- or two-level lumbar arthrodesis. Patients were randomized in two groups treated with either reusable or single-use device. A cost minimization analysis was performed using a micro-costing approach from a hospital perspective. Every step of the preparation process was timed and costed based on hourly wages of hospital employees, cleaning supplies and hospital waste costs. RESULTS: Forty cases were evaluated. No significant difference in operation time was noted (reusable 176.1 ± 68.4 min; single use 190.4 ± 71.7 min; p = 0.569). Mean processing time for single-use devices was lower than for reusable devices (33 min vs. 176 min) representing a cost of 14€ versus 58€ (p < 0.05). Pre-/post-sterilization and spinal set recomposing steps were the most time-consuming in reusable device group. A total cost saving of 181€ per intervention resulted from the use and processing of the single-use device considering an additional sterilization cost of 137€ with the reusable device. The weight of the reusable device was 42 kg for three containers and 1.2 kg for the single-use device. CONCLUSIONS: Owing to the absence of re-sterilization, single-use devices in one- and two-level lumbar fusion allow significant money and time savings. They may also avoid delaying surgery in case of reusable device unavailability.

Beta-tricalcium phosphate for orthopedic reconstructions as an alternative to autogenous bone graft.

Autogenous bone graft (autograft) remains the gold standard in the treatment of many orthopedic problems. However, graft harvest can lead to perioperative morbidity and increased cost. We tested the hypothesis that an osteoconductive matrix, beta-tricalcium phosphate (ß-TCP), would be a safe and effective alternative to autograft alone. Beta-tricalcium phosphate (ß-TCP) is considered as one of the most promising biomaterials for bone reconstruction. This study analyzes the outcomes of patients who received ß-TCP as bone substitutes in orthopedic surgery. METHODS: A total of 50 patients were enrolled in a controlled, non-inferiority clinical trial to compare the safety and efficacy of ß-TCP (25 patients) with those of autograft (25 patients) in indications requiring usually autograft. These 50 patients were categorized according to the etiology and morphology of the 54 bone defects resulting from elective surgical procedures, such as 34 open-wedge high tibial osteotomies, and 20 osteonecrosis treatments with core decompression. Radiographic (healing process with or without integration of ß-TCP), clinical (no other surgical procedure), functional outcomes and safety (with or without complications) were assessed through fifty-two weeks postoperatively. RESULTS: With regard to the primary endpoint (radiographic evolution), the fusion rate of the 34 open-wedge osteotomies was 100% (17 among 17) for patients in the group with ß-TCP compared with 94% (16 among 17) for patients in the autograft group. For the 20 cavitary defects (osteonecrosis), the radiographic union rates, as determined by the presence of osseous bridging, were 100% for patients in the group with ß-TCP and 100% for those in the autograft group. Clinically at one year, all quality-of-life and functional outcome data supported non-inferiority of ß-TCP compared with autograft, and patients in the ß-TCP group were found to have less pain and an improved safety profile. CONCLUSIONS: Treatment with ß-TCP resulted in comparable fusion rates, less pain and fewer side effects as compared with treatment with autograft. This study established clinical parameters where the ß-TCP alone can successfully support the osteogenic process.

Failure of high tibial varus osteotomy for lateral tibio-femoral osteoarthritis with<10° of valgus: Outcomes in 19 patients.

BACKGROUND: Osteotomy is a rational approach to slowing knee osteoarthritis progression by modifying loads, thereby avoiding joint replacement in younger individuals. Varus femoral osteotomy is recommended only in patients with more than 10° of valgus. The objective here was to assess outcomes of tibial varus osteotomy in patients with lateral compartment tibio-femoral osteoarthritis and less than 10° of valgus. The hypothesis was that high tibial varus osteotomy produces satisfactory and long-lasting improvements. MATERIAL AND METHODS: A single-centre retrospective study was conducted in 19 consecutive patients managed by high tibial varus osteotomy between January 2005 and May 2012. Mean age was 54.5years. The clinical IKS knee and function scores and radiological parameters were determined pre-operatively then after 6 and 12months and at last follow-up. The primary outcome measure was the global IKS score. Failure was defined as a global IKS score <140 or total knee arthroplasty (TKA). Secondary outcome measures were a post-operative hip-knee-ankle (HKA) angle between 180° and 183° and less than 10° of joint line obliquity. The hypothesis was that high tibial varus osteotomy produced satisfactory and long-lasting improvements in lateral compartment tibio-femoral osteoarthritis. RESULTS: After the mean follow-up of 4.3years (range, 2-9years), 10/19 patients had a global IKS score <140. Among them, 7 underwent TKA after a mean of 5.0±2.7years. Varus tibial osteotomy was followed by significant improvements in the IKS knee and function scores from baseline to last follow-up (P<0.05). A global IKS<140 predicted TKA. Mean HKA angle values were 186.3±2.9° pre-operatively and 181.3°± 3.9°at last follow-up (P<0.05); the HKA angle was within the 180°-183° range in 8 (42.1%) patients. Mean post-operative joint line obliquity was 7.8±3.0°. An HKA angle outside the 180-183° range and joint line obliquity >10° were associated with poor outcomes. DISCUSSION: High tibial varus osteotomy produces unsatisfactory medium-term outcomes, with an overall failure rate of 52%. At present, high tibial varus osteotomy has no role in the management of lateral compartment tibio-femoral osteoarthritis with <10° of valgus. LEVEL OF EVIDENCE: IV, retrospective cohort study.

Late local recurrence, at 19 and 17 years, of sacral chordoma treated by en bloc resection.

UNLABELLED: Sacral chordoma (SC) is a malignant bone tumor with high risk of local recurrence (LR) even after en bloc resection, generally in the first 10 years after resection. We report two cases of late LR, at 17 and 19 years. Two male patients, aged 45 and 53 years, presented with large SC needing a combined approach for en bloc resection. Surgical margins were safe for the first patient and borderline for the second. The patients had yearly follow-up. The first patient developed LR on the posterior wall of the right acetabulum and the second developed LR in the right sciatic notch, at 17 and 19 years, respectively. These two cases of very late LR of SC advocate for yearly screening of patients even more than 20 years after resection. LEVEL OF EVIDENCE: IV (case report).

Surgery in vertebral fracture: epidemiology and functional and radiological results in a prospective series of 518 patients at 1 year's follow-up.

INTRODUCTION: Recent epidemiological data for spinal trauma in France are sparse. However, increased knowledge of sagittal balance and the development of minimally invasive techniques have greatly improved surgical management. OBJECTIVES: To describe the epidemiology and management of traumatic vertebral fracture, and to analyze evolution and risk factors for poor functional outcome at 1 year's follow-up. MATERIALS AND METHODS: A prospective multicenter French cohort study was performed over a 6-month period in 2011, including all cases of vertebral fracture surgery. Data were collected by online questionnaire over the Internet. Demographic characteristics, lesion type and surgical procedures were collected. Clinical, functional and radiological assessment was carried out at 1 year. RESULTS: Five hundred and eighteen patients, with a mean age of 47 years, were included. Sixty-seven percent of fractures involved the thoracic or lumbar segment. Thirty percent of patients had multiple fractures and 28% neurological impairment. A minimally invasive technique was performed in 20% of cases and neurological decompression in 25%. Dural tear was observed in 42 patients (8%). Seventy percent of patients were followed up at 1 year. Functionally, SF-36 scores decreased on all dimensions, significantly associated with age, persistent neurological deficit and previous spine imbalance. Thirty-eight percent of working patients had returned to work. Radiologically, sagittal balance was good in 74% of cases, with fracture consolidation in 70%. DISCUSSION: Despite progress in management, spinal trauma was still a source of significant morbidity in 2011, with pronounced decrease in quality of life. Conserved sagittal balance appeared to be associated with better functional outcome.