Abstract
Background:
Although the modified Brostrom procedure has had excellent clinical results, postoperative complications such as skin irritation by suture material and problematic scar formation occur. This prospective study was performed to evaluate the clinical outcomes of mini-open ligament augmentation (internal brace technique) using suture tape for chronic ankle instability in a select cohort of patients.
Methods:
Thirty-four young female patients with less than 70 kg of body weight were followed for more than 2 years after suture tape augmentation for lateral ankle instability. The clinical evaluation consisted of the Foot and Ankle Outcome Score (FAOS), Foot and Ankle Ability Measure (FAAM) score, Sefton grading system, and the period to return to various activities. Measurement of talar tilt angle and anterior talar translation was obtained from stress radiographs to evaluate the longevity of mechanical ankle stability.
Results:
FAOS and FAAM scores had significantly improved to 92.5 points at final follow-up (P < .001). According to the Sefton grading, 31 cases (91.2%) achieved satisfactory functional results. The period to return to exercise was on average 10.2 weeks for jogging and 9.6 weeks for walking on uneven ground. The average subjective satisfaction score of patients was 93.8 points, and satisfaction with the scar was 98.5 points. Talar tilt angle and anterior talar translation had significantly improved to an average of 4.5 degrees and 4.1 mm, respectively, at final follow-up (P < .001). There were no complications such as skin irritation and wound infection, except for 1 case of chronic inflammation.
Conclusions:
Minimally invasive suture tape augmentation seems to be an effective alternative for young women with chronic ankle instability. Because there is a possibility of progressive elongation over time, the longevity of mechanical ankle stability and the proper indication for using the internal brace technique should be addressed in future studies.
Level of Evidence:
Level IV, case series study.
Ankle sprains are the most commonly reported orthopedic injuries, and the incidence is increasing. Although most patients with lateral ankle sprains are treated nonoperatively, some people develop chronic ankle instability.2,12,18,25 Of the surgical techniques for chronic ankle instability, the modified Brostrom procedure is currently used most frequently, and its excellent treatment outcomes have been reported.3,12,18 However, this procedure is not always the best surgical technique in patients with chronic ankle instability. There have been significant technical advances in surgical procedures for treating chronic lateral ligament instability.2,3 Trends in recent years include minimally invasive ligament repair and reconstruction surgery. The use of such minimally invasive techniques has been accompanied by developments in surgical instruments and anatomic knowledge. Such techniques include the percutaneous lateral ligament reconstruction using auto- or allo-tendon graft,11,14,28 the arthroscopic Brostrom repair,10,13,27 and lateral ligament augmentation using suture tape. 26 Biomechanical studies6,10,26 have shown that minimally invasive techniques for lateral ligament stabilization can produce stiffness and strength equivalent to the results achieved with traditional methods. Recently, patient-specific surgical techniques for chronic ankle instability have emerged. These patient-specific techniques take into account individual characteristics, such as occupation, age, body weight, sports activity, concern for cosmesis, and severity of mechanical instability.4,5,10
Although the concept of using nonabsorbable suture tape to augment the modified Brostrom repair for lateral ankle ligament rupture has been proposed, 26 no prospective clinical studies of this technique are available. We hypothesized that ligament augmentation using suture tape without Brostrom repair would have excellent clinical results in well-selected patients with chronic ankle instability. The ankle stability required by people for ordinary daily life differs from that needed by athletes engaged in sporting activity.12,16,18 Therefore, some patients with chronic ankle instability may obtain satisfactory clinical outcomes with only simple augmentation of ankle stability. In this study, we prospectively evaluated the clinical outcomes of mini-open ligament augmentation (internal brace technique) using suture tape without concomitant modified Brostrom procedure for chronic lateral ankle instability.
Methods
Between October 2011 and December 2012, 34 young female patients less than 70 kg of body weight were consecutively enrolled in the current study. All patients were under 40 years of age and were followed for more than 2 years after undergoing mini-open ligament augmentation (internal brace technique) using suture tape for chronic lateral ankle instability. The indications for surgery were (1) patients who complained of subjective instability of the ankle joint, in whom repeated sprain injuries for more than 6 months and pain were confirmed, and (2) patients with marked ankle instability confirmed by the varus stress test compared with the contralateral ankle and tenderness involving the lateral ligaments of the ankle confirmed on physical examination. The current study included patients who complained of unilateral ankle instability and who weighed less than 70 kg. Patients who were heavy laborers or high-demand athletes were excluded. All operations were performed by 1 surgeon. The mean age of the patients was 26.2 years (range, 16-38 years), and the mean length of follow-up was 31.4 months (range, 24-39 months). The study protocol and investigation received institutional review board approval. Arthroscopic procedures were concomitantly performed in 19 subjects. Lesions combined with chronic ankle instability were identified by preoperative physical examination and magnetic resonance imaging (MRI). We included only cases with simple arthroscopic synovectomy or debridement, because the cases with osteochondral lesions or peroneal tendon problems were subjected to different rehabilitation protocols.
Surgical Technique and Postoperative Rehabilitation Method
First, concomitant arthroscopic synovectomy or debridement through anteromedial and anterolateral portals was carried out as needed. Skin was marked along the path of the anterior talofibular ligament (ATFL) and calcaneofibular ligament (CFL) under intraoperative fluoroscopy. Then, 3 small incisions were made at the anterior border of the lateral malleolus, lateral surface of the talar neck, and lateral wall of the calcaneal body, respectively. To confirm the exact entry point of suture anchors, we used temporary K-wire placement using intraoperative fluoroscopy (Figure 1). Initially a SwiveLock biocomposite suture anchor (4.75 mm in diameter; Arthrex, Naples, FL) was inserted over the ATFL insertion into the anterior border of the lateral malleolus, with 2 bundles of FiberWire suture tape (Arthrex) (Figure 2). Special attention was paid to insertion depth and direction to avoid penetration into the articular surface or retromalleolar groove. One bundle of FiberWire suture tape was subcutaneously passed through a portal at the center of the talar neck (about 1 cm anterior and superior to the sinus tarsi), over the extensor retinaculum. The other bundle of FiberWire suture tape was passed through a portal over the lateral wall of the calcaneus, beneath the peroneal tendons (Figure 3). We routinely checked the pathway of the peroneal tendons to prevent impingement between tendons and suture tape. While the ankle joint was maintained in neutral flexion and 5 degrees of valgus, the second SwiveLock suture anchor was inserted over the ATFL insertion into the talar neck, and 1 bundle of suture tape with maximal tension was securely fixed by a SwiveLock knotless suture anchor. Finally, the third SwiveLock suture anchor was inserted over the CFL insertion into the lateral wall of the calcaneal body, and the other bundle of suture tape was fixed. The remnants of FiberWire suture tape were cut out, level with the knotless suture anchors. The skin was then closed (Figure 4). Accurate placement of the suture anchors and stability of ankle joint were checked via intraoperative fluoroscopy (Figure 5).

(A) Intraoperative photograph showing the pathway and anatomic origin of the anterior talofibular and calcaneofibular ligaments. (B) Confirmation of entry points (dots) of suture anchors through temporary K-wires inserted under fluoroscopic guidance.

Biocomposite SwiveLock anchor and FiberWire suture tape.

Intraoperative photographs of internal brace technique. (A) Insertion of the first knotless anchor into the anterior border of lateral malleolus. (B) Passage of 1 bundle of suture tape beneath the peroneal tendons. (C) Passage of the other bundle of suture tape subcutaneously. (D) Insertion of the third knotless anchor into the talar neck.

Photographs showing scars (A) immediately postoperatively and (B) 1 year postoperatively.

Postoperative radiographs showing the location of anchors and suture tape (arrows indicate the entry points of anchors).
A short leg splint and nonweightbearing ambulation with crutches were maintained for 2 weeks postoperatively. Thereafter, an elastic ankle bandage was used, and range of motion (ROM) exercises and partial weightbearing ambulation were encouraged. Full weightbearing gait was permitted from postoperative week 4, followed by peroneal muscle strengthening exercises and proprioception training. A return to exercise at the preinjury level was permitted on confirmation of recovery of ankle stability through physical examination and stress radiography at 3 months postoperatively.
Ninety-six percent of patients were followed up on the appointed schedule (postoperatively 6 months, 1 year, and 2 years); others were called back to the hospital and reevaluated by the corresponding author.
Clinical and Radiological Assessment
Clinical evaluation consisted of the Foot and Ankle Outcome Score (FAOS), 23 Foot and Ankle Ability Measure (FAAM) score, 19 Sefton grading system, 25 the time required to return to exercise, and the patients’ subjective satisfaction scores. The FAOS and FAAM scores were measured prior to surgery, at 6 months postoperatively, and at final follow-up. The FAOS is a self-estimated test that consists of 42 questions and 5 subscales evaluating pain, other symptoms, activities of daily living, sports activities, and quality of life. The FAAM is comprised of 2 subscales evaluating activities of daily living (21 questions) and sports activities (8 questions). The Sefton grade was measured at final follow-up and was classified as excellent, good, fair, or poor. In the current study, a Sefton grade rated good or excellent was evaluated as a satisfactory result. The periods to return to various exercises (jogging, sprint running, jumping, standing on 1 leg for longer than 1 minute, walking on uneven ground, descending stairs) were evaluated with a single assessment numeric test through questionnaires at 2 months, 3 months, 6 months, and 1 year postoperatively. The questionnaire included 6 exercise items, and the ability to do each exercise was measured by visual analog scale from 0 to 10. A score of 0 indicated that a condition allowed exercise without pain or discomfort, and a score of 10 indicated a condition with severe pain or discomfort during exercise. After self-estimation with the questionnaire, patients with a score of 2 or lower were questioned again about the exact time.
Mechanical stability was evaluated by anterior drawer and varus stress radiography 15 using Telos equipment (Telos GmbH, Marburg, Germany) with the same loading force (150 N) preoperatively; at 3 months, 6 months, and 1 year postoperatively; and at final follow-up. The talar tilt angle and degree of anterior talar translation were independently measured by 2 orthopedic surgeons. Measures were repeated 3 times and subsequently averaged.
Statistical analysis was performed to compare the clinical and radiological outcomes between preoperative and postoperative groups. Nonparametric statistical tests and the Mann-Whitney test (SPSS, version 19.0) were used. P < .05 was considered statistically significant.
Results
The FAOS significantly improved from a mean of 63.1 points (range, 82-100 points) preoperatively to 93.2 points (range, 82-100 points) at final follow-up (P < .001). Comparisons of each subscale showed that there was statistical difference in all 5 subscales between preoperative and postoperative FAOS (Table 1).
Evaluation of Clinical Outcomes Based on the Foot and Ankle Outcome Score (FAOS) (Mann-Whitney Test) a .
Abbreviations: ADL, activities of daily living; QOL, quality of life.
Results are expressed as mean ± SD. Values are changes in scores based on a maximum of 100 points.
The FAAM score significantly improved from a mean of 56.2 points (range, 82-100 points) preoperatively to 92.5 points (range, 82-100 points) at final follow-up (P < .001) (Table 2).
Evaluation of Clinical Outcomes Based on the Foot and Ankle Ability Measure (FAAM) (Mann-Whitney Test) a .
Results are expressed as mean ± SD. Values are changes in scores based on a maximum of 100 points.
Based on the Sefton grading system, the patient sample consisted of 14 excellent cases, 17 good cases, and 3 fair cases at final follow-up. Therefore, 31 cases (91.2%) achieved satisfactory functional results (Table 3).
Evaluation of Functional Results With the Sefton Grading System.
On the functional assessment regarding return to exercise, the times required for subjects to perform each exercise comfortably were as follows: mean 10.2 weeks for jogging, mean 13.8 weeks for sprint running, mean 11.4 weeks for jumping, mean 8.5 weeks for standing on 1 leg, mean 9.6 weeks for walking on uneven ground, and mean 10.4 weeks for descending stairs. The ROM of the ankle was improved to full range by 3 months postoperatively in all but 4 patients. These 4 patients displayed decreased inversion of 5 to 15 degrees and then regained full range of motion at final follow-up.
The patients’ subjective satisfaction score was an average 93.8 points, and satisfaction with the cosmetic appearance of the scar was an average 98.5 points at final follow-up.
On stress radiography, talar tilt angle significantly improved from a mean of 16.3 degrees (range, 6-25 degrees) preoperatively to a mean of 4.5 degrees (range, 1-10 degrees) at final follow-up (P < .001). Anterior talar translation significantly improved from 12.4 mm (range, 5-20 mm) preoperatively to mean 4.1 mm (range, 2-10 mm) at final follow-up (P < .001) (Table 4). Side-to-side comparisons of talar tilt and anterior talar translation were significantly different preoperatively, but these differences showed no statistical significance at final follow-up (P = .448 and .892, respectively) (Table 5).
Evaluation of Mechanical Stability Through Stress Radiographs (Paired t Test) a .
Results are expressed as mean ± SD.
Comparison Between Injured and Uninjured Side With Ankle Stress Radiographs (Mann-Whitney Test).
No patient had skin irritation from the suture material, and there were no wound infections. In the 1 case of chronic inflammation, the patient complained of persistent swelling around the scar following ambulation or exercise but experienced no problems in function of the ankle, including gait. We found focal tenderness over the suture tape implantation site between the lateral malleolus and calcaneus. However, there were no abnormal findings suggesting an infection on physical examination and hematologic testing. After conservative treatment for 6 months postoperatively, we removed the suture tape and the modified-Brostrom procedure was performed using suture anchors (Figure 6). Histological examination showed chronic inflammation with foreign body reaction. Satisfactory clinical and functional recovery was achieved.

Photographs showing chronic inflammation by foreign body (suture tape) reaction.
Discussion
Recent techniques reflecting a trend toward minimally invasive ligament repair or reconstruction surgery have been introduced. Such techniques include percutaneous lateral ligament reconstruction using auto- or allo-tendon graft,11,14,28 arthroscopic Brostrom repair,10,13,27 and lateral ligament augmentation using suture tape. 26 Recent biomechanical studies6,10,26 showed that minimally invasive techniques for lateral ligament stabilization are equivalent in stiffness and strength to traditional methods. Commonly reported advantages of minimally invasive techniques for lateral ligament stabilization include smaller incision, less surgical dissection, less perioperative morbidity, early protected range of motion, and faster patient recovery.10,11,27 Miller et al 20 reported good clinical results, which included 95 points on FAAM scores and 89% of patients satisfied, at 32 months of follow-up after near-anatomic allograft lateral ligament reconstruction for recurrent ankle instability. Kim et al 13 reported that nearly all patients returned to their preinjury levels with a mean American Orthopaedic Foot & Ankle Society (AOFAS) score of 92 and significant improvements in stress tests at 16 months of follow-up after arthroscopic Brostrom repair. These results were similar to our clinical outcomes. Comparison of the mechanical stability between studies was difficult because of the lack of objective data such as stress radiographs. While we can conclude clinically that mini-open ligament augmentation (internal brace technique) using suture tape was successful, we were unable to make an objective conclusion by directly comparing this procedure with other minimally invasive ligament repair or reconstruction techniques. Further prospective comparative studies are needed to examine the differences between minimally invasive techniques.
Information about the complications and the longevity of mechanical stability following minimally invasive techniques is still insufficient. Corte-Real and Moreira 7 reported 3 cases of recurrence of instability, 3 cases of superficial peroneal nerve injuries, and 4 cases of knot problems at 24 months of follow-up after arthroscopic lateral ligament repair in 31 patients. Kim et al 13 reported 3 cases of prominent asymptomatic suture knots among 28 patients. A recent systemic review 27 concluded that arthroscopic lateral ligament repair was useful but was associated with a relatively high complication rate. Miller et al 20 reported 3 cases of persistent instability at 32 months of follow-up after percutaneous allograft tenodesis in 28 patients. The high cost and possibility of an immunogenic response associated with allograft use are still of concern. 14 Also, harvesting an autograft such as semitendinosus tendon can be difficult and can cause donor site morbidity. The internal brace technique for lateral ligament augmentation using nonabsorbable suture tape can lead to chronic inflammation followed by a foreign body reaction, which is a source of concern and was seen in 1 patient in our study.
Modified Brostrom procedures require adequate quality and quantity of the remaining ligamentous tissue and retinaculum; a deficiency of repairable tissues may result in recurrence of the ankle instability. The most well-known reconstructive option for these conditions is a nonanatomic tenodesis using the peroneal tendons.9,24 However, recent studies report that anatomic ligament reconstruction using auto- or allo-tendon graft is a more successful surgical technique, pointing out many disadvantages of the nonanatomic tenodesis.1,8,11,28 We modified the concept of percutaneous anatomic ligament reconstruction using allograft and evaluated the possibility of simple ligament augmentation without the modified Brostrom repair in chronic lateral ankle instability. We felt that suture tape augmentation combined with the modified Brostrom procedure might have constituted overtreatment in most patients with chronic ankle instability. We hypothesized that ligament augmentation using suture tape without modified Brostrom repair would have good clinical results in well-selected patients with chronic ankle instability. So, subjects in this study were limited to young female patients under 70 kg of body weight who did not need strong mechanical stability. Patients who were heavy laborers or high-demand athletes were excluded.
The internal brace technique used in this study can prevent postoperative complications such as skin irritation by suture material or unsightly scar formation, because flat suture tape and knotless anchors were used. The most common postoperative complication following a modified Brostrom procedure in our hospital has been skin irritation by retained suture materials (about 6%-7% after modified Brostrom procedure using the bone tunnel technique, and about 4%-5% after modified Brostrom procedure using the suture anchor technique). The more we used nonabsorbable sutures during ligament imbrication or reattachment to obtain stronger mechanical stability, the more skin irritation from suture materials occurred. This problem occurred mostly in young female patients with thin subcutaneous tissue and required frequent removal of nonabsorbable suture materials under local anesthesia. The patients in this study showed no complications such as skin irritation by suture material or wound infection, except for 1 case of chronic inflammation. Since the true ATFL and CFL are flat broad structures, suture tape can reproduce the lateral ligaments of the ankle with a more similar shape than allograft tendons. There is still a question whether a difference in mechanical stability between the suture tape and allograft tendon makes any difference with regard to the clinical and functional results over time.
We suggest that advantages of our internal brace technique include fewer surgical dissections and postoperative complications, technical ease, no donor site morbidity, and decreased operation time. In addition, this technique can be useful as an augmentation procedure combined with a modified Brostrom repair for cases with recurrent instability after surgery and for cases with relative contraindications (high-demand athletes and laborers, severely obese patients, and patients with long-term instability) after a modified Brostrom repair; the technique may be an alternative revision technique for failed cases after ligament reconstruction using tendon graft. Operation time excluding the arthroscopic procedure, obtained from analysis of medical records, indicated a mean 17.8 minutes for minimally invasive suture tape augmentation. Although these results did not undergo statistical analysis, these results were shorter than the operation time and hospitalization period for our conventional technique (modified Brostrom procedure using suture anchor or bone tunnel). With our conventional technique, operation time excluding the arthroscopic procedure was usually between 30 and 40 minutes. In addition, patients complained of less postoperative pain during the hospitalization period in the current study than with the conventional technique. We did not use patient-controlled analgesia in most patients.
Despite discouraging results and lack of confidence by the scientific community regarding the use of synthetic materials, a resurgence of interest in artificial ligaments has occurred.17,21,22 Previously, most materials in artificial anterior cruciate ligament reconstruction presented serious drawbacks, such as immunologic responses, debris dispersion leading to synovitis, and recurrent instability by mechanical failure. 17 The main advantages of the use of a synthetic ligament are that stability is recovered immediately, rehabilitation can begin early, and the morbidity of harvesting autologous structures is avoided. FiberWire suture tape is a flat suture composed of ultra-high-molecular-weight polyethylene and polyester yarns braided over a core of FiberWire. We thought that a suture tape for the internal brace technique positioned outside of the joint capsule would minimize those complications in our study. In this study, we noted only 1 case of chronic inflammation, which might have been related to a foreign body reaction. Although the prevalence of inflammation (2.9%) was lower than we expected, immune reaction by a foreign body (suture tape) after the internal brace technique is a concern and should be addressed through long-term follow-up of more patients.
Some authors9,24 have suggested that clinical results are worsened by progressive elongation over time of the lateral ankle ligaments after the modified Brostrom procedure. In this study, the talar tilt angle and the anterior talar translation did not show statistically significant changes between the immediate postoperative period and the final follow-up. No patients had recurrent functional instability. We cannot be sure how our internal brace technique works biologically, since we do not have any objective data based on histologic analysis (by second-look arthroscopy) or follow-up magnetic resonance imaging scan. We believe that the mechanical stability of the ankle joint was recovered by ligament augmentation using the suture tape and that this stability prevented more injury (recurrent sprain) to the lateral ligament tissues, leading to gradual functional improvement. If revision surgery is needed for recurrent ankle instability after ligament augmentation using suture tape, surgeons must consider the potential problem of retained suture anchors. A nonabsorbable suture tape is easily removed by simply cutting the knotless anchors. Because we used bioabsorbable anchors to avoid a hardware removal problem as well as difficulties related to future reconstruction, the degree of progress to complete biodegradation seems to be important in the selection of the position of bone tunnels or suture anchors. One patient required revision surgery due to chronic inflammation after the ligament augmentation using suture tape. When we removed the suture tape and performed the modified Brostrom procedure using 2 metallic suture anchors at 6 months postoperatively, there was no difficulty related to previous bioabsorbable anchors.
Conclusion
Minimally invasive suture tape augmentation without the modified Brostrom procedure seems to be an effective alternative for young women with chronic ankle instability. In addition to providing satisfactory functional outcomes and restoration of ankle stability, this surgical technique has the advantage of causing less postoperative skin irritation and minimal scarring. Because there is a possibility of progressive elongation over time postoperatively, future studies should address the longevity of mechanical ankle stability and the proper indications for the internal brace technique.
Footnotes
Declaration of Conflicting Interests
The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding
The author(s) received no financial support for the research, authorship, and/or publication of this article.
