Foot & Ankle International

Although considerable literature can be found on the outcome of total ankle replacement (TAR), only a few studies have reported the results of the fixed-bearing Cadence prosthesis. This noninventor study reports a consecutive series of 60 Cadence TAR systems with a mean of 2.9 years’ follow-up, focusing on clinical and radiographic outcomes and early complications. This study is the first to assess true postoperative radiographic ankle prosthesis range of motion (ROM) and to report an unanticipated serious adverse device effect.

Sixty patients who underwent primary TAR with the Cadence prosthesis between July 2016 and July 2019 were clinically and radiographically evaluated preoperatively and at last follow-up after the procedure. Revisions, additional procedures, implant failure, and complications were reported according to the classifications of Vander Griend and Glazebrook. Radiographic outcomes included radiographic TAR ROM, bone-implant interface, and alignment parameters.

The survival rate of the prosthesis was 98.3%. The mean radiographic ankle ROM at the last follow-up was 24 degrees (9 degrees of dorsiflexion and 15 degrees of plantarflexion). The coronal and sagittal alignment of TAR was 90.8 degrees and 3.9 degrees, respectively. Bone-implant interface analysis revealed osteolysis in 9 ankles (15%) and radiolucent lines in 33 ankles (55%) occurring at both component interfaces. Intraoperative complications were 3 periprosthetic malleolar fractures (5%). Five talar implant fractures (implant failure of 8.3%) were observed, and 1 unexplained persistent pain that required a conversion from TAR to a tibiotalocalcaneal arthrodesis.

Clinical, radiograph ROM, implant position outcomes, and survival rate at an early-term follow-up of 2.9 years were similar to those reported in recent Cadence studies. However, this study reports 5 unanticipated talar implant fractures and a high rate of posterior radiolucent lines.

Level IV, retrospective case series.

There are 2 general types of total ankle replacement (TAR) designs with respect to the polyethylene insert, mobile-bearing (MB) and fixed-bearing (FB) TARs. The aim of this study is to compare polyethylene-related adverse events (AEs), particularly revisions, reported for MB TARs and FB TARs using the US Food and Drug Administration’s (FDA’s) Manufacturer and User Facility Device Experience (MAUDE) database.

A text mining method was applied to the medical device reporting (MDR) in the MAUDE database from 1991 to 2020, followed by manual reviews to identify, characterize, and describe all polyethylene-related AEs, including revisions, reported for MB and FB TARs.

We found 1841 MDRs for MB (STAR Ankle only) and 1273 MDRs for 40+ FB TARs approved/cleared by the FDA. For the MB design, 33% (606/1841) of the AEs reported related to the polyethylene component, compared to 24% (291/1273) of the AEs reported for FB designs. Polyethylene fractures were reported in 11.3% (208/1841) for the MB designs compared to 0.2% (2/1273) for the FB designs. Half of the polyethylene-related revisions occurred within an average of 4.1 years after implantation for the MB design compared within an average of 5.2 years for FB designs.

Analysis of this database revealed a higher proportion of reported polyethylene fractures and greater need for earlier revisions for polyethylene-related issues with use of the primary MB design in the database as compared with FB TAR designs. Further study of device-related complications with more recent designs for both MB and FB ankle replacement components are needed to improve the outcomes of total ankle replacement.

Level III, retrospective comparative study.

In response to the opioid epidemic, the use of multimodal pain management in orthopaedic surgery is increasing. Efforts to decrease opioid prescribing and opioid consumption among foot and ankle surgical patients are needed. The purpose of this study was to compare the efficacy and adverse events between 2 multimodal pain management pathways for forefoot surgical patients: standard opioid-containing (OC) and opioid-free (OF).

This is a single-center noninferior randomized controlled trial of 51 patients undergoing forefoot surgery allocated to one of 2 perioperative pain management treatments: opioid-free, multimodal (OF, n=27 patients), or traditional opioid-containing (OC, n=24 patients). Patient characteristics, creatine markers, pain (numeric rating scale [NRS]), general health (Veterans Rand 12-Item Health Survey [VR-12]), and depression were measured preoperatively. Postoperatively, pain was measured at 24-hour, 2-week, and 6-week time points. Satisfaction with pain control, complications, and general health were measured at 2 and 6 weeks.

The OF group is statistically noninferior to the OC group and reported lower median pain scores at 24 hours (2 [IQR 0, 3] vs 6 [IQR 3.5, 7]; p<.0001) and 2 weeks (2 [IQR 1, 4] vs 4 [IQR 0, 3]; p=.018]. By 6 weeks, pain levels were similar between groups. More than 85% of all patients reported satisfaction with pain level at 2 weeks, which increased to >90% at 6 weeks. The VR-12 scores were similar between groups across all time points. At 2 weeks, 8 patients in each group reported constipation. By 6 weeks, all but 2 OC patients reported resolution. No other adverse events of postoperative wound complications, readmissions, medication reactions, thrombosis, or persistent pain were documented.

In forefoot surgery, the opioid-free pain management protocol was statistically noninferior to the opioid-containing protocol in reducing postoperative pain.

Level II, prospective cohort study.

The aim of this study was to compare outcome (clinical, patient-reported outcome measures, radiologic, joint motion and pedographic) of total joint replacement with Roto-Glide (RG) and arthrodesis (A) for severe osteoarthritis of the first metatarsophalangeal joint (MTP1).

All consecutive patients with arthrodesis and RG from January 23, 2011, until September 18, 2019, at the authors’ institution were considered for inclusion in the study. Preoperatively and at follow-up (FU), radiographs, and/or weightbearing computed tomographic imaging were obtained. Standard dynamic pedography was performed. Visual analog scale foot and ankle (VASFA), European Foot and Ankle Society (EFAS) score, MTP1 range of motion for dorsiflexion/plantarflexion (DF/PF) were registered and compared preoperatively and at FU.

Seventy RG and 72 arthrodesis patients were included. Preoperative VASFA and EFAS scores did not differ between the RG and arthrodesis groups (average scores: VASFA, 50.6 and 45.6; EFAS score, 10.7 and 10.6, respectively; each P > .05). Wound healing delays without further operative measures were registered in 4 patients (6%) for RG and 5 (7%) for arthrodesis (P = .67), and 5 revisions in 5 patients (7%) for RG and 12 in 8 (11%) for arthrodesis (P = .05). The longest available FU was higher in RG than in arthrodesis (47 vs 37 months on average, P < .001). Pedography showed higher first metatarsal head or sesamoids and lower great toe force percentage from force of entire foot in RG than in arthrodesis (P = .05) resulting in physiological pattern in RG only. VASFA and EFAS scores at FU was higher in RG than in arthrodesis (average scores: VASFA, 72.6 and 63.6; EFAS score, 16.1 and 14.1, respectively; each P < .05). DF/PF measurement was only possible in RG (average value: DF/PF, 36.1/14.0).

We found marginally lower revision rates and higher patient-reported outcome measures, joint motion (DF/PF), and more physiologic force distribution at slightly longer FU for the RG group than the arthrodesis group. Longer follow-up and broader clinical reporting are needed to identify the potential deficits of RG.

Level III, retrospective cohort study.

We report the short-term outcomes of a retrospective cohort of Trabecular Metal total ankle arthroplasties (TAAs) via a transfibular approach from a single, nondesigner surgeon in Australia.

This was a retrospective cohort study. Demographic, clinical, and patient-reported outcome measures (PROMs) were collected. The primary outcome was the Foot and Ankle Outcome Score (FAOS), and secondary outcomes included patient satisfaction, the EuroQol-5 Dimension (EQ5D), and complications including revision rates.

Between 2016 and 2019, 84 trabecular metal prostheses were implanted in 84 patients. Mean age (SD) at time of surgery was 68 (7.8) years, and 46 (55%) were male. Mean follow-up (SD) was 26.1 (13) months. There were significant (P < .001) improvements in the FAOS in the subscales of pain (47.9 to 79.1), activities of daily living (59.5 to 83.7), and quality of life (25.5 to 60.2) and EQ-5D (0.55 to 0.75) (P < .001), and overall satisfaction was 69.6%. The commonest complications were wound infection or breakdown (11.9%, n=10), fibular nonunion (3.5%), plate irritation (3.5%), and tibial nerve neuropathy (3.5%). There were no thromboembolic complications. Implant survivorship was 100%, with Trabecular Metal components retained in all patients. Two patients developed deep infection, with 1 requiring debridement and polyethylene exchange. No patients experienced implant loosening.

Our results demonstrate that the trabecular metal survival rates are comparable with other total ankle implants in the Australian Orthopaedic Association National Joint Replacement Registry and as published in other international literature. Overall patient satisfaction was high, as were PROMs. However, the data highlight potential complications uniquely associated with this implant. The authors believe that these figures support TAA via a transfibular approach as a viable option in the treatment of ankle arthritis.

Level IV, retrospective cohort study.

Dual semitendinosus allograft reconstruction of chronic Achilles tendon ruptures has several potential benefits including superior tensile strength compared with a turndown construct and avoidance of the morbidity and operative time associated with autograft augmentation. We present a series of chronic Achilles tendon ruptures reconstructed with dual semitendinosus allograft.

We retrospectively reviewed the charts of patients aged 18 years and older who underwent reconstruction of chronic Achilles tendon ruptures using dual semitendinosus allograft. The primary outcome of this study was to evaluate the need for revision surgery. Secondary outcomes included patient-reported outcomes, for which Achilles Tendon Rupture Scores (ATRS) were collected at final follow-up. Nine patients with a mean age of 58.9 (range, 43-75) years met inclusion criteria.

Median follow-up was 66 months (range, 27-121 months). One patient (11.1%) required revision reconstruction after sustaining graft failure 9.5 years after her index procedure, and 1 patient reported a poor ATRS score at the 27-month final follow-up despite an intact surgical repair. At final follow-up, no patient required the use of an assistive device for ambulation or a walking boot. The median ATRS at final follow-up was 93 (range, 30-100).

Good clinical outcomes without rerupture were observed in 7 of 9 patients (77.8%) at short- to midterm follow-up, suggesting that dual semitendinosus allograft reconstruction is a viable option for the reconstruction of chronic Achilles tendon tears.

Level IV, case series.

The quality of reduction of the distal tibiofibular joint (DTFJ) has a major impact on the outcome. Novel suture-button systems as well as intraoperative 3D imaging can be applied to increase the quality of DTFJ reduction intraoperatively. The individual effect of either remains unknown. The aim of this study was to investigate the value of intraoperative 3D imaging on the quality of reduction of the DTFJ when using a suture-button system.

Retrospective, radiographic study including adult patients who underwent surgical stabilization of the syndesmosis with a suture-button system for acute, unilateral, unstable syndesmotic injuries with postoperative bilateral CT imaging. The use of an intraoperative 3D scan was the individual surgeon’s choice. Assessed was whether the intraoperative 3D imaging had an influence on the postoperative quality of DTFJ reduction and revision rates. These findings were put in perspective to the correction potential of the suture-button system.

A total of 147 patients were included; 76 of these received an intraoperative 3D imaging. Neither the rate of formal malreduction (17% vs 17%) nor the postoperative revision rate (4% vs 3%) differed significantly between patients with or without intraoperative 3D imaging. Intraoperative 3D imaging revealed a false-negative rate of 14%. The intrinsic correction potential of the suture-button system reduced the number of formally malreduced DTFJs in both groups by 51%.

The additional value of intraoperative 3D imaging to assess the quality of DTFJ reduction in our series did not improve syndesmotic reduction when using a flexible suture-button system.

Level III, retrospective comparative cohort study.

U-osteotomy with Taylor Spatial Frame correction is a rarely reported treatment method particularly well-suited for severe rigid equinus deformity in adults. The purpose of this study was to evaluate the effectiveness and efficacy of deformity correction and clinical outcome using this technique.

We present a retrospective review of 30 feet in 26 patients who received U-osteotomy with Taylor Spatial Frame. Radiologic outcomes were measured using the anterior tibiotalar angle (TTA) with conventional weightbearing radiographs. Functional assessments included American Orthopaedic Foot & Ankle Society (AOFAS) ankle and hindfoot scores and patient satisfaction using Likert scale.

The etiology included trauma (9), neglected or relapsed clubfoot (6), spina bifida (5), poliomyelitis (4), Charcot-Marie-Tooth disease (4), and iatrogenic (2). All patients had equinus deformity with TTA more than 140 degrees (median 157.5, 141-177). There were varus deformity in 19 feet, limb length discrepancy in 6 legs, and genu procurvatum deformity in 2 legs. The duration of gradual correction was 53.6±13.5 days (33-73 days), and the external fixation time was 147.8±25.2 days (98-203 days). At last follow-up, TTA in all patients improved significantly (P < .001) to 113.5 degrees (111.8-116.0). All patients had plantigrade feet, except for 2 cases of residual mild equinovarus deformity, 2 cases of residual mild hindfoot varus deformity, 1 case of moderate hindfoot varus recurrence. The AOFAS scores significantly improved (P < .001) from 51.0 points (29.0-66.0) to 76.0 points (69.5-88.0). Eighteen patients were very satisfied, 6 patients were somewhat satisfied, and 2 patients were somewhat dissatisfied.

Using minimally invasive U-osteotomy with Taylor Spatial Frame to gradually correct the adult severe rigid equinus deformity proved to be an effective and relatively safe method associated with high patient satisfaction rates.

Level IV, case series.

This study sought to determine whether range of motion (ROM) of the ankle and subtalar joint complex (STJ) is correlated with ankle injuries in National Basketball Association (NBA) G-league and collegiate basketball players to identify an at-risk population that may benefit from participation in an ankle injury prevention program.

This prospective cohort study encompassed 103 player-seasons (68 collegiate, 35 NBA G-League). Patient demographics, passive ankle and STJ range of motion measurements, anterior drawer, and talar tilt tests were collected at preseason physicals along with plain radiographs. Subtalar eversion and inversion measurements were added to assess the Combination Motion (CM) of the STJ and subtracted to calculate the Subtalar Difference (SD). We defined the ratio of CM to SD as Subtalar Mobility Index (SMI=CM/SD).

Twenty-one ankle injuries occurred with 10 405 player exposures yielding an incidence of 2.11/1000 exposures, resulting in 113 days of missed playing time. No direct measures of ankle, subtalar, or combined motion were associated with risk of injury, rejecting our original hypothesis that increased STJ ROM would predispose to ankle injuries. However, we did find that athletes with CM >16 degrees in combination with either SD <6 degrees (P = .025) or SMI >3.75 (P = .032) were nearly 3 times more likely to have an ankle injury (3.14 vs 2.97, respectively).

Using the predictive subtalar mobility thresholds found in this study may help identify at-risk players that may benefit from targeted ankle injury prevention programs.

Level II, prospective cohort study.

The plantar plate is a major stabilizing structure of the metatarsophalangeal (MTP) joint with instability frequently occurring after a tear or attenuation of this structure. Commonly, a McGlamry elevator is used to strip the plantar plate from the plantar surface of the metatarsal to improve exposure of the MTP joint. The anatomy of the proximal plantar plate and vascular consequence of stripping the plantar plate from the metatarsal is not yet well understood. The purpose of this study is to describe the proximal attachment of the plantar plate anatomically and quantify the relative contribution of blood supply to the proximal plantar plate from both the metatarsal and the plantar fascia.

For anatomic evaluation, 6 lower extremity cadaver specimens without any gross evidence of foot and ankle deformity were utilized. For imaging analysis, 16 fresh frozen human adult cadaveric lower extremity specimens were used for this study, resulting in 35 MTP joints without deformity and 11 lesser MTP joints with cockup and/or crossover deformities. The specimens were prepared as described previously by Finney et al.⁵

From gross anatomic dissection, the plantar plate origin consists of a stout fibrous pedicle distinct from the surrounding synovial-type tissue that firmly anchors the plantar plate to the metatarsal. Based on nano–computed tomographic imaging, an average of 63.5% of the vascular supply to the proximal portion of the plantar plate entered from the metatarsal pedicle. The remaining 36.5% of the vascular supply entered from the plantar fascia.

The proximal attachment of the plantar plate includes a stout fibrous pedicle anchoring the proximal portion of the plantar plate to the notch between the medial and lateral plantar condyles of the metatarsal head. The vascular supply of the proximal plantar plate is supplied from both the metatarsal pedicle and plantar fascia.

Level III, retrospective comparative study.

Changes in lower extremity alignment in individuals with flatfoot may be associated with differences in morphology of the tendons or cartilage in lower extremities. The purpose of the present study was to investigate the potential association of flatfoot with the morphology of the Achilles tendon, patellar tendon, and femoral cartilage.

This study was conducted with 40 participants with flatfoot (28 females, 12 males) and 40 participants with a normal foot posture (28 females, 12 males). The thickness of the Achilles tendon (at points 2 and 3 cm proximal to the superior aspect of the calcaneus), patellar tendon (at the inferior pole of the patella and 1 cm proximal of the inferior pole of the patella), and femoral cartilage (at the intercondylar area, medial condyle, and lateral condyle) was measured by an ultrasonography device.

The Achilles tendon thickness at 2 cm (P = .009) and 3 cm (P = .010) proximal of the superior aspect of the calcaneus was on average 4% to 6% lower in individuals with flatfoot compared with controls. The cartilage thickness at the intercondylar area (P = .005) and medial condyle (P = .018) was on average 8% to 12% greater in individuals with flatfoot; however, the cartilage thickness at the lateral condyle and patellar tendon thickness was similar in both groups.

The results obtained suggest that foot posture is associated with the morphology of the Achilles tendon and femoral cartilage.

Level III, diagnostic comparative study.