|Year : 2019 | Volume
| Issue : 1 | Page : 1-5
Bone marrow stimulation plus bone marrow aspirate concentrate versus bone marrow stimulation alone in the treatment of osteochondral lesions of the talus: A prospective study
Christine Park1, John R Steele2, Samuel B Adams2
1 Department of Surgery, Duke University School of Medicine, Durham, NC, USA
2 Department of Orthopaedic Surgery, Duke University Medical Center, Durham, NC, USA
|Date of Submission||10-Jun-2019|
|Date of Decision||22-Jul-2019|
|Date of Acceptance||14-Aug-2019|
|Date of Web Publication||28-Feb-2020|
Dr. John R Steele
Department of Orthopaedic Surgery, Duke Clinic Building Duke University Medical Center, Box 3000, 40 Medicine Circle, Room 5309, Durham, NC 27710
Source of Support: None, Conflict of Interest: None
Background: Bone marrow stimulation (BMS) has proven to be the standard treatment for small osteochondral lesions of the talus (OLTs). It has been theorized that bone marrow aspirate concentration (BMAC) has the potential to enhance cartilage repair stimulated by BMS. The aim of this study was to prospectively compare the effect of BMS with BMAC versus BMS alone on patient-reported outcomes after the treatment of OLTs.
Methods: This is a single-institution, randomized prospective study. Patients over the age of 18 with OLTs who were proceeding with BMS were included in the study. Patients with multiple OLTs and follow-up period of <1 year were excluded from the study. Patients were randomized to receive BMS alone or BMS with BMAC. Patient-reported outcome scores, including the visual analog scale pain, Short Musculoskeletal Function Assessment, Short Form-36, and Foot and Ankle Disability Index, were compared between the two cohorts.
Results: Nine patients were evaluated in the study. Six patients were in the BMS with BMAC group, and three patients were in the BMS alone group. Average final follow-up was >2 years for both groups. Both groups showed improvements in patient-reported outcome scores from preoperatively to final follow-up. There were no significant differences in final outcome scores or changes in outcome scores from preoperatively to final follow-up between the two groups.
Conclusion: Our study found that both BMS alone and BMS with BMAC treatments are effective in improving pain and functional outcomes in patients with OLTs. There were no significant differences between the two modalities of treatment. This is a pilot study and a larger randomized trial is needed to make definitive conclusions.
Keywords: Bone marrow aspirate concentrate, bone marrow stimulation, osteochondral lesion of the talus, talus
|How to cite this article:|
Park C, Steele JR, Adams SB. Bone marrow stimulation plus bone marrow aspirate concentrate versus bone marrow stimulation alone in the treatment of osteochondral lesions of the talus: A prospective study. Duke Orthop J 2019;9:1-5
|How to cite this URL:|
Park C, Steele JR, Adams SB. Bone marrow stimulation plus bone marrow aspirate concentrate versus bone marrow stimulation alone in the treatment of osteochondral lesions of the talus: A prospective study. Duke Orthop J [serial online] 2019 [cited 2020 May 29];9:1-5. Available from: http://www.dukeorthojournal.com/text.asp?2019/9/1/1/279432
| Introduction|| |
Osteochondral lesions of the talus (OLTs) are often associated with ankle sprains and fractures, with OLTs occurring in up to 70% of ankle injuries.,,,, Detection of OLTs has also become more sensitive due to the emergence of technologically advanced imaging techniques such as magnetic resonance imaging (MRI). Symptoms related to OLTs include instability, pain, swelling, stiffness, and decreased range of motion. The increasing prevalence of these lesions and their effect on pain and functional outcomes of patients have spiked interest in the search for optimal treatment of OLTs.
The course of treatment for OLTs depends on the size and location of the lesion. Cartilage repair is recommended for the primary treatment of OLTs of size <150 mm2 in the area and includes techniques such as bone marrow stimulation (BMS)., Cartilage regeneration or replacement is suggested for larger lesions and revision treatment., If the OLT extends into the shoulder of the talus or has large subchondral cysts, then allograft or OAT is the preferred treatment; otherwise, regenerative treatments are preferable.
BMS has been the gold standard for treating small lesions for its role in stimulating repair by providing infill at the site of cartilage defect., However, there is conflicting evidence in its short-term success rates in producing good results that range from 39% to 96%.,,,, There are also questions of the durability and long-term outcomes associated with BMS because it results in the formation of fibrocartilage composed largely of Type I collagen which is weaker than the native hyaline cartilage made up primarily of Type II collagen. It is largely accepted that the decreased quality of the repaired cartilage can result in faster degradation and poor long-term clinical outcomes. For example, Hunt and Sherman showed that less than half of patients undergoing arthroscopic BMS procedures demonstrated good or excellent results over 66 months. Moreover, Becher et al. reported that all 25 patients undergoing microfracture of OLTs showed chondral fibrillation and fissuring on MRI 3.6–9.6 years following BMS.
To enhance the positive effect of BMS for cartilage repair in treating small-sized OLTs, biological adjuncts such as bone marrow aspirate concentration (BMAC) have been trialed. Because of its composition of mesenchymal and hematopoietic stem cells which can differentiate into chondrogenic/osteogenic progenitor cells and platelets, respectively, BMAC has the potential to enhance the quality of cartilage repair by helping to generate hyaline cartilage.,, While it has been shown that BMS coupled with BMAC demonstrates improved defect filling and tissue integration compared to BMS alone in the treatment of OLTs, limited data exist on its effect on patient-reported outcomes. The purpose of this prospective study is to determine whether BMS plus BMAC resulted in improved patient-reported pain and functional outcomes compared to BMS alone in the treatment of OLTs.
| Methods|| |
Our hospital's Institutional Review Board approved this prospective, randomized study. We prospectively enrolled patients over the age of 18 who had an OLT and who were undergoing arthroscopic BMS. The OLT had to be <150 mm2 in area and could not extend into the shoulder of the talus. The decision to undergo arthroscopic BMS was made jointly by the treating surgeon and patient, and there were four surgeons included in this study. Exclusion criteria included age <18, the presence of multiple OLTs, and follow-up <1 year. Patients were randomized into one of two groups, namely the BMS plus BMAC group and the BMS alone group. The study could not be blinded as patients and physicians would know who received BMAC based on bandages over the anterior superior iliac spine (ASIS) following surgery. Seventeen patients were enrolled in the study. Three patients were withdrawn from the study after enrollment, two patients were withdrawn by the treating surgeon as multiple OLTs were discovered during surgery, and one patient withdrew after enrolling because the patient no longer wanted surgery. Five patients did not complete follow-up of at least 1 year and were thus excluded from the study. This left a total of nine patients with complete data in the study, six patients in the BMS plus BMAC group, and three patients in the BMS alone group. Data reviewed included patient demographics, location and size of OLT, concomitant procedures, and complications. Patients completed outcome measures, including visual analog scale (VAS) pain, Short Musculoskeletal Function Assessment (SMFA), Short Form-36 (SF-36), and Foot and Ankle Disability Index (FADI) preoperatively and at the 3-month, 6-month, 1-year, 2-year, and 4-year time points.
| Surgical Technique|| |
Surgical technique was similar across all patients and among the four attending surgeons. A nonsterile tourniquet was utilized, and appropriate preoperative antibiotic prophylaxis was provided. Patients were placed supine, and the leg was positioned in a well-padded bolster. The operative extremity was exsanguinated with an Esmarch bandage, and the tourniquet was inflated to 300 mmHg. Then, an external traction device was placed to distract the tibiotalar joint. Anteromedial and anterolateral portals were made, and accessory portals were made as needed per the attending surgeon. The OLT was located, measured, and debrided to a stable edge, then BMS was performed using a standard awl. In the BMS alone group, attention was then turned toward any concomitant procedures that were necessary. In the BMS plus BMAC group, the BMAC was then injected. BMAC was acquired through protocol by obtaining 60 cc of bone marrow aspirate from the ipsilateral iliac crest just posterior to the ASIS, concentrating the aspirate via centrifugation, and then injecting it into the tibiotalar joint after the portal sites were closed with 2-0 vicryl and 3-0 nylon. Attention was then turned toward any concomitant procedures. In all patients, sterile dressings were applied, and the patients were placed into a controlled ankle motion boot and made nonweight bearing until their 2-week visit. At that point, weight-bearing was advanced to weight-bearing as tolerated.
The primary outcome measure was improvement in patient-reported outcome scores. Patients completed VAS pain, FADI, SF-36, and SMFA outcome measures preoperatively and at 3-month, 6-month, 1-year, 2-year, and 4-year time points. Final follow-up was defined as the patient's last follow-up that was at least 1 year after surgery. The average change in each outcome score was calculated for the BMS plus BMAC and BMS alone groups and compared between them. Secondary outcome measures included perioperative and postoperative complications. Normally distributed continuous variables were compared using a Student's t-test, and nonparametric continuous variables were compared using a Wilcoxon–Mann–Whitney test. The Chi-squared or Fisher's exact test (for expected counts <5) was used to compare the categorical data. The software utilized for statistical analysis was JMP Pro 14 (SAS Institute, Inc., Cary, NC, USA). P < 0.05 was considered as statistical significance.
| Results|| |
Patients who met the inclusion criteria had an average age of 44.8 years. There were 7 males and 2 females. There were 7 left OLTs and 2 right OLTs. The average size of the OLTs was 71.0 mm2. Five of the OLTs were located in the medial talar dome, 3 were located in the lateral talar dome, and 1 was located in the central talar dome. The average body mass index was 31.5, and none of the patients had diabetes mellitus or peripheral vascular disease. A total of three concomitant procedures were performed, including 2 lateral ankle repairs and 1 ganglion cyst excision. Average final follow-up was 2.5 years for the BMS plus BMAC group and 2.0 years for the BMS alone cohort. There were no significant differences between the BMS plus BMAC and BMS alone groups in regard to patient or operative characteristics [Table 1].
|Table 1: Comparison of patient and operative characteristics between bone marrow stimulation with bone marrow aspirate concentrate and bone marrow stimulation alone cohorts|
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In both the BMS plus BMAC and BMS alone groups, improvements in VAS pain, SMFA, SF-36, and FADI outcome scores were seen from preoperatively to final follow-up on average. In the BMS alone group, VAS pain improved from 2.9 to 2.1, SMFA dysfunction improved from 13.0 to 8.6, SF-36 health improved from 54.2 to 66.7 and FADI disability improved from 75.3 to 89.3. For the BMS plus BMAC group, VAS pain improved from 1.9 to 0, SMFA dysfunction improved from 5.9 to 0.5, SF-36 health improved from 50.0 to 66.7 and FADI disability improved from 89.4 to 99.3. None of these were statistically significant. In comparing the BMS plus BMAC and BMS alone cohorts, there were no significant differences in the average improvement of patient-reported outcome scores from preoperatively to final follow-up [Table 2].
|Table 2: Comparison of average changes in outcome scores from preoperative assessment to final follow-up between the two cohorts|
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| Discussion|| |
BMAC consists of mesenchymal stem cells and hematopoietic stem cells which have the potential to promote tissue regeneration and enhance quality of cartilage repair. BMAC is thus theorized to augment BMS technique such as microfracture by promoting an optimal environment for hyaline cartilage growth and repair. The proof of concept demonstrating superiority of combined BMS with BMAC treatment in terms of repair efficacy has been validated across different animal models., Clinically, Fortier and her team showed that the repair cartilage in lesions treated with BMS with BMAC had better integration and healthier thickness and surface profile than those treated with BMS alone in lesions of the equine femur. These results are further supported by Hannon et al. in their recent study that found that BMAC coupled with BMS is associated with improved MRI findings such as defect filling, border repair integration, and surface tissue repair compared to BMS alone for OLTs. There have not been any studies that reported significant complications or adverse outcomes attributed to BMAC.
Although previous studies have looked into imaging results comparing the two options of intervention for treating OLT, there are limited data on the benefit of BMAC on patient-reported outcomes. Murphy et al. found that while both BMS with BMAC and BMS alone groups showed improvements in pain, activities of daily living, sports, quality of life, and symptoms pre- and post-operatively within each group, there was no significant difference between the two groups regarding these measures. The revision rate was significantly lower in the BMS plus BMAC group versus the BMS alone group (P = 0.014).
Similarly, we found that VAS pain score, SMFA, SF-36, and FADI outcome scores, all improved postoperatively within the BMS plus BMAC and BMS alone groups. However, there were no significant differences in the average change in outcome scores between the two groups. Our results indicate that the improved cartilage repair profile for combined BMS with BMAC treatment as demonstrated through imaging does not necessarily translate to improved patient-reported outcomes such as pain and quality of life. However, our observed lack of significance in the comparison outcomes could be due to the low number of patients in this study (n = 9) or the relatively short average follow-up period (2.5 years for BMS with BMAC group and 2 years for BMS alone group). Longer average follow-up time should be considered because one of the arguments for the superiority of BMAC is the quality of cartilage repair which is dependent on the generation of hyaline cartilage-containing Type-II collagen. The interval of 2 years' average in pre- and post-operative comparison may not be sufficiently long for degeneration to occur for BMS-only patients who are at increased risk for cartilage degeneration from the relatively weaker fibrocartilage. Hence, a longer follow-up period would better elucidate whether improved cartilage characteristic confers additional benefit in terms of pain and functional outcomes. Another explanation for our results is the difference in the size of the lesions in the two groups (average lesion size of BMS with BMAC group of 78.9 mm2 and that of BMS alone group of 55.3 mm2). The difference in average size, although not statistically significant due to the small sample sizes, may be a confounding factor as smaller lesions often produce less pain and functional deficit. The BMS plus BMAC group had a larger average size, which may have had a negative impact on outcome scores following surgery.
One of the limitations of our study is the small sample sizes which hinder the ability to achieve statistically significant differences. Another limitation is our measurement of the average improvement in outcome scores at different follow-up points (1, 2, or 4 years). This could introduce a confounding factor in our analysis because patients can have different pain perception at 1 year and 4 years postoperatively. Lastly, there was a high drop-out rate in this study which may have confounded results.
| Conclusion|| |
Our prospective study found that patient-reported outcomes including VAS pain, SMFA, SF-36, and FADI scores, all improved in patients who received either BMS alone or BMS with BMAC. However, there were no significant differences in the change in scores from preoperatively to final follow-up between the two cohorts. Limitations of this study include its short-term follow-up, the small number of patients and the high drop-out rate. Further investigation with more patients and longer follow-up is necessary to further elucidate the potential benefits of using BMAC along with BMS for OLT.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2]