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To study clinical outcome of patients with bilateral ankle chondral defects treated with High-Density Autologous Chondrocyte Implantation (HD-ACI) in the same surgical act.
Cases presentation
Two men (27 and 48 years-old) with chondral defects in both ankles evidenced by MRI. Chondral lesions were treated with HD-ACI in the same surgical act and anesthesia, consecutively. Patients were evaluated 2, 6 and 12 months after surgery to check for treatment safety and efficacy. Pain, evaluated by the Visual Analogic Scale (VAS), decreased from very high values (8.5 – 9) to normal or almost normal scores one year after surgery (0 – 1). Ankle functionality measured by the American Orthopedic Foot & Ankle Society score (AOFAS) and quality of life evaluated by the EuroQol five-dimensional five-level questionnaire (EQ-5D-5L) behaved similarly to pain. Thus, both parameters increased and/or slightly decreased at 2 months (AOFAS score: 53 and 51; EQ-5D-5L score: 0.42 and 0.33) and reached their maximum value at 12 months (AOFAS score: 90 and 89; EQ-5D-5L score: 0.89 and 0.91). MRI from both ankles revealed that chondral defects were filled with a material of similar aspect to the surrounding cartilage.
Conclusion
Treatment of both ankles with HD-ACI in the same surgical act in patients with bilateral chondral lesions is a safe procedure, providing positive results from the clinical and patients’ quality of life points of view.
In current medical practice, cell therapy and regenerative medicine techniques, such as autologous chondrocyte implantation (ACI), are some of the best options to treat OLT.
In MACI (Matrix-Assisted Chondrocyte Implantation) version, cells were seeded onto a porcine type I/III collagen membrane as a carrier at a density of 1 million cells per cm2, facilitating cell delivery to the chondral defect.
We developed a modification of MACI technique, called High Density-Autologous Chondrocyte Implantation (HD-ACI), which features a 5-fold increase in the number cells, resulting in 5 million chondrocytes per cm2 of lesion using a porcine type I/III collagen membrane being implanted on the chondral defect. This technique has been successfully used to treat chondral lesions in the knee
In this work, we describe the treatment with HD-ACI in the same surgical act in 2 patients with bilateral ankle chondral lesions.
Cases presentation
Here we describe the treatment in two male patients (27 and 48 years old) with bilateral ankle cartilage lesions treated with HD-ACI. The study was conducted in accordance to the ethical standards of the Helsinki Declaration of 1964, revised in 2013. Patients included in the study signed an informed consent.
Patient 1 had an osteochondral lesion of 10 mm × 6 mm in size in the superomedial corner of the talus in the left foot, and a chondral defect of 9 mm × 10 mm in size and bone edema in the superomedial corner of the talus in the right ankle. Patient 2 had an osteochondral lesion of 16 mm × 8 mm in size located in the superomedial corner of the talus in the left foot, together with subchondral cyst and bone edema, and an osteochondral lesion of 14 mm × 6 mm in size of the superomedial corner of the talus in the right ankle. In both cases, cartilage lesions were diagnosed by X-ray and confirmed by magnetic resonance (MRI).
Patients underwent a first arthroscopy to harvest a cartilage biopsy from the anterior talar neck of one of the ankles. Isolation and culture of cells were carried-out following previously described procedures.
Chondrocytes loaded in a resorbable porcine type I/III collagen membrane (Chondro-Gide, Geistlich Biomaterials, Wolhusen, Switzerland) were implanted in a second surgery.
In the same surgical act we successively operated both ankles, under the same anesthesic procedure. Main steps followed during surgery are shown in Fig. 1. As previously described,
in each ankle we first proceeded with a 5 cm longitudinal approach on medial malleolus and once the periosteal plane was reached, anterior and posterior tibial malleolus points were marked. Flexor retinaculum was then accessed and posterior tibial tendon was protected using a separator. To fix bone osteotomy, guide needle positioning and threading then followed prior to tibial osteotomy for both 4.5 mm partial thread malleolar screws (Fig. 1a). Under radioscopy control, perpendicular axis of osteotomy was marked in lesion apex of zone 4 according to Elias classification
and after screws were removed, a cut was made towards the internal cortex. While carefully handling adjacent soft tissues, tibial malleolus was proximally lifted with a bone clamp providing access to lesion. The edges and the bed of osteochondral lesion were debrided, leaving perpendicular edges along its perimeter (Fig. 1b). The membrane was then fixed to the surrounding cartilage using either 5-0 Vicryl resorbable suture or transosseous sutures, followed by fibrin sealant (Fig. 1c). Once forced manual flexion-extension movements confirmed overall stability, X-rays were then performed to confirm all elements had been properly fixed (Fig. 1d).
Fig. 1Main steps followed during high-density autologous chondrocyte implantation (HD-ACI). Before performing the tibial osteotomy, guide needles were positioned and threaded for both 4.5 mm partial thread malleolar screws to fix bone cut (a). After osteotomy, the edges and the bed of the ostechondral lesion were debrided, leaving perpendicular edges along its perimeter (b). Membrane was then fixed to the surrounding cartilage (c). Manual flexion-extension movements were performed to confirm overall stability and X-rays then confirmed all elements had been properly fixed (d).
Patients then underwent mobilization programme with no weight-bearing from the first week until the 6th – 8th week, followed by 6 – 8 weeks of progressive weight-bearing with crutches which also included the start of physical-therapy sessions. During the 6 – 8 non weight-bearing weeks, patients received DVT (Deep Venous Thrombosis) prophylaxis with 3,500 IU bemiparin injection every 24 hours. At 4 months, patients may also be involved in stationary bicycle sessions and swimming. At 10 – 12 months they were allowed to jog slowly.
Treatment effectiveness was assessed by evaluating pain using the Visual Analogical Scale (VAS) and American Orthopaedic Foot & Ankle Society (AOFAS) ankle-hindfoot score
at 2, 6 and 12 months follow-up. EuroQol five-dimensional five-level questionnaire (EQ-5D-5L) and Visual Analogic Scale for health included in the questionnaire were used to evaluate overall health of patients.
Patients underwent MRI at 6- and 12- months follow-up. Adverse events including swelling and bone edema were recorded at 3-, 6- and 12-month follow-up to evaluate treatment safety.
Results
After chondrocyte implantation neither patient had swelling, bone edema, DVT nor other surgery-derived complications. With respect to pain, as seen in Table 1, both patients had a high pre-op VAS score which slightly decreased at 2 months and dramatically decreased at 6 months to reach almost normal scores at 12 months (Table 1). Evolution of ankle functionality measured by AOFAS and quality of life evaluated by EQ-5D-5L along the study are depicted in Fig. 2. In both patients, both parameters evolved similarly to pain: values increased and/or slightly decreased at 2 months and rapidly increased at 6 months to reach a maximum score at 12 months (Fig. 2). Six- and twelve-month MRIs from both ankles in both patients are shown in Fig. 3. In the 4 ankles, images revealed that chondral defects were filled with a material similar to normal surrounding cartilage. Subchondral cyst evidenced before treatment in patient 2 and bone edema presented in both cases in the baseline were not detected at 12-month follow-up MRI.
Table 1VAS score in both patients throughout the study
Fig. 2Evolution of AOFAS (A) and EQ-5D-5L (B) questionnaires values along the study. In both patients values increased and/or slightly decreased at 2 months and rapidly increased at 6 months to reach a top score at 12 months.
Fig. 3Patient 1 (a1-d1) and patient 2 (a2-d2) MRIs taken from right (a1, c1, a2, c2) and left (b1, d1, b2, d2) ankles, 6 (a1, b1, a2, b2) and 12 (c1, d1, c2, d2) months after surgery. Images revealed that chondral defects were filled with a material similar to the normal surrounding cartilage. Some artifacts due to screws are evidenced, preventing subchondral cyst and bone edema detection.
In this work we present two cases of patients with bilateral ankle cartilage chondral defects treated with HD-ACI, whose feet were successively operated in the same surgical act, under the same anesthesia. After 1-year follow-up, clinical outcome and quality of life improved when compared to pre-surgery condition. As described in a previous study conducted on patients with bilateral knee cartilage lesions, the main issue is to decide whether to operate both limbs in the same surgical act or in separate ones.
In this previous study, eight patients with bilateral knee chondral defects consecutively treated with HD-ACI, were included. We first explained the pros- and cons- of each option to patients and they decided whether they would like to undergo one or two surgeries.
If two surgeries was their choice, after recovering from the first surgery, patients would likely need to spend more time to return to previous activities, due to the burden of those two surgeries, yet on the other hand, these patients may have less mobility issues throughout their recovery time as just that one leg is immobilized after each surgery. If patients’ choice was to undergo one single surgery they only have to recover from one surgery while suffering the inconvenience of having both legs immobilized.
In that work we concluded that simultaneous treatment of chondral defects from both limbs with HD-ACI is a safe procedure with good results in terms of clinical outcome and quality of life.
Given the good results obtained in the knee we followed the same procedure with cartilage lesions in both ankles and 2 patients accepted to have just one surgery in which one ankle was operated after the other.
One year after surgery both patients had almost normal values of pain (measured by VAS) and high AOFAS score which indicates a satisfactory clinical outcome in both cases. It is noteworthy that the difference in the AOFAS score compared with the basal one was 3 and -2 at 2 months and increased to 31 and 19 at 6 months, reaching 40 and 36 at 12 months in both cases. It has been published that Minimal Clinically Important Difference in the AOFAS for hallux valgus surgery is 7.9 to 30.2.
Although hallux valgus surgery is a different medical condition than that of our patients, a difference of 40 and 36 at 12 months in our patients may give us the idea that they perceived this as a real improvement. Furthermore, these good clinical outcomes are accompanied by the absence of adverse events, good MRI results and quality of life improvement. It is also worth mentioning that MRI did not reveal the presence of neither bone edema nor bone cyst. However, this result is not conclusive since during surgery two screws were placed to promote osteotomy consolidation and may interfere with magnetic fields in the MRI giving rise to artifacts that can lead to image misinterpretation. Chondrocyte implantation in the ankle implies the need to carry-out a medial malleolus osteotomy to access the chondral lesion and treat it (two osteotomies in bilateral cases). This fact may well influence post-operative rehabilitation and could delay weight-bearing. However, both patients followed the prescribed post-operative program and schedule, showing that bilateral chondral lesion treatment neither influenced post-operative rehabilitation nor delayed weight-bearing.
Both patients received DVT prophylaxis during the non-weight-bearing period. No thrombotic episodes were observed in either patient, indicating that venous thromboembolism prophylaxis was effective. There are no clear guidelines published about DVT prohylaxis in foot and ankle surgery, due to the wide variety and complexity of injuries and procedures as well as post-operative protocols.
The American College of Foot and Ankle Surgeons has published a clinical consensus statement for perioperative management of foot and ankle surgery patients.
In this document, expert panel concluded that the routine use of pharmacologic antithrombotic prophylaxis may not be necessary in all cases but should be considered for some patients with high risk of venous thromboembolism development. Such a prolonged time of non-weight-bearing (6 – 8 weeks) is a risk factor for DVT which is why we consider that DVT prophylaxis is necessary and, from our experience, leads to satisfactory results.
Scarce literature about simultaneous surgery on both ankles due to any bilateral lesion has been published. Recently, Gordon et al.
Bilateral vs unilateral minimally invasive hallux valgus surgery: a propensity matched case-control study with 2 year clinical patient reported outcomes.
published a study comparing bilateral vs unilateral minimally invasive surgery for hallux valgus. The study demonstrates that there is no difference in clinical outcome between patients who underwent bilateral versus unilateral surgery. Furthermore, no differences in both clinical and radiological parameters were found between both groups of patients and according to the authors, this finding should encourage surgeons to consider performing bilateral surgery.
Bilateral vs unilateral minimally invasive hallux valgus surgery: a propensity matched case-control study with 2 year clinical patient reported outcomes.
Of course, chondrocyte implantation in the ankle is a more aggressive surgery requiring a longer postoperative recovery period than hallux valgus surgery. However, we decided to offer our patients with bilateral ankle chondral lesions to have a single surgery supported by our results in patients with bilateral knee chondral defects.
Bilateral vs unilateral minimally invasive hallux valgus surgery: a propensity matched case-control study with 2 year clinical patient reported outcomes.
performing one single procedure has a positive impact in the health system by reducing costs: it involves a single hospitalization and thus, total hospital stay is reduced; risks of anesthesia exposure are lower and rehabilitation time decreases, leading to earlier return of patients to their previous life status.
This study represents a first approach to bilateral ankle chondral defects by simultaneous treatment with HD-ACI. In this case report we only describe the technique used in 2 patients and the results obtained after one-year follow-up. The number of patients with bilateral ankle or knee chondral defect with HD-ACI is very low, and thus, a study comparing treatment with one or two surgical procedures and with a longer follow-up period is now being planned, in order to define the advantages of having one or two surgeries.
In conclusion, simultaneous treatment at the same surgical act with HD-ACI of both chondral defects of patients with bilateral cartilage defects in the ankle may be a good option. Patients undergoing this option have a satisfactory clinical outcome and a positive impact on their quality of life.
Patient informed consent statement
This work has been approved by the Educational and Research Committee of the Institution, and informed consent was obtained from the patients.
Declaration of Competing Interests
The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
Acknowledgments
We would like to thanks Mario Wensell for carefully revising the linguistics for this article.
References
Murawski CD
Kennedy JG.
Operative treatment of. osteochondral lesions of the talus.
Bilateral vs unilateral minimally invasive hallux valgus surgery: a propensity matched case-control study with 2 year clinical patient reported outcomes.
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