We report one- and 2-year results of a prospective, 5-year, multicenter study of radiographic, clinical, and patient-reported outcomes following triplanar first tarsometatarsal arthrodesis with early ...weightbearing. One-hundred and seventeen patients were included with a mean (95% confidence interval CI) follow-up time of 16.6 (15.5, 17.7) months. Mean (95% CI) time to weightbearing in a boot walker was 7.8 (6.6, 9.1) days, mean time to return to athletic shoes was 45.0 (43.5, 46.6) days, and mean time to return to unrestricted activity was 121.0 (114.5, 127.5) days. There was a significant improvement in radiographic measures with a mean corrective change of -18.0° (-19.6, -16.4) for hallux valgus angle, -8.3° (-8.9, -7.8) for intermetatarsal angle and -2.9 (-3.2, -2.7) for tibial sesamoid position at 12 months (n = 108). Additionally, there was a significant improvement in patient-reported outcomes (Visual Analog Scale, Manchester-Oxford Foot Questionnaire, and Patient-Reported Outcomes Measurement Information System) and changes were maintained at 12 and 24 months postoperatively. There was 1/117 (0.9%) reported recurrence of hallux valgus at 12 months. There were 16/117 (13.7%) subjects who experienced clinical complications of which 10/117 (8.5%) were related to hardware. Of the 7/117 (6.0%) who underwent reoperation, only 1/117 (0.9%) underwent surgery for a nonunion. The results of the interim report of this prospective, multicenter study demonstrate favorable clinical and radiographic improvement of the HV deformity, early return to weightbearing, low recurrence, and low rate of complications.
Background: The results supporting Cartiva, a synthetic cartilage implant (Wright Medical) in hallux rigidus have come from limited institutions creating observational bias. Complications experienced ...in community centers are not routinely included in the published literature. To look at a broader range of potential complications, we reviewed the United States Food and Drug Administration’s (FDA) voluntary device database and compared that data with published literature. Methods: The Manufacturer and User Facility Device Experience (MAUDE) database of the FDA was retrospectively reviewed between July 2016 and October 2019 using the product code: PNW, assigned for Cartiva. Results: A total of 49 events have been reported and implant subsidence was the most common with 16 reports. Others include fragmentation (9), infection (4), bone erosion (3), foreign body reaction (1) and unspecified (16). Thirty-five events mentioned further surgeries at a mean interval of 4.75 months. Conclusions: The analysis of the MAUDE database disclosed certain device-related dysfunctions that have been underreported in the published literature. Because of the voluntary nature of reporting, the true incidence of each complication is unknown with this data representing a baseline. The MAUDE database could be further strengthened by a more robust reporting mechanism or mandatory reporting of device-related complications.
Levels of Evidence: Level IV: Case series from large database analysis
Abstract Conservative treatment (non-operative) of Achilles tendon ruptures is suggested to produce equivalent capacity for return to function; however, long term results and the role of return to ...activity (RTA) for this treatment paradigm remain unclear. Therefore, the objective of this study was to evaluate the long term response of conservatively treated Achilles tendons in rodents with varied RTA. Sprague Dawley rats ( n = 32) received unilateral blunt transection of the Achilles tendon followed by randomization into groups that returned to activity after 1-week (RTA1) or 3-weeks (RTA3) of limb casting in plantarflexion, before being euthanized at 16-weeks post-injury. Uninjured age-matched control animals were used as a control group ( n = 10). Limb function, passive joint mechanics, tendon properties (mechanical, histological), and muscle properties (histological, immunohistochemical) were evaluated. Results showed that although hindlimb ground reaction forces and range of motion returned to baseline levels by 16-weeks post-injury regardless of RTA, ankle joint stiffness remained altered. RTA1 and RTA3 groups both exhibited no differences in fatigue properties; however, the secant modulus, hysteresis, and laxity were inferior compared to uninjured age-matched control tendons. Despite these changes, tendons 16-weeks post-injury achieved secant stiffness levels of uninjured tendons. RTA1 and RTA3 groups had no differences in histological properties, but had higher cell numbers compared to control tendons. No changes in gastrocnemius fiber size or type in the superficial or deep regions were detected, except for type 2x fiber fraction. Together, this work highlights RTA-dependent deficits in limb function and tissue-level properties in long-term Achilles tendon and muscle healing.
Category:
Midfoot/Forefoot
Introduction/Purpose:
There is still a controversy regarding the most optimal fixation instruments and bone graft materials for midfoot joint arthrodesis. We present the ...results of midfoot joint arthrodesis using compression plate highly porous β-tricalcium phosphate (β-TCP) and bone marrow aspirate concentrate (BMAC).
Methods:
We performed a retrospective review of patients undergoing midfoot joint arthrodesis using compression plate with lag screw augmenting with highly porous β - tricalcium phosphate (β - TCP) and bone marrow aspirate concentrate (BMAC) from January 2014 to May 2019. The radiographic bony union rate was investigated. Postoperative complications and reoperations were also noted. A total of 36 patients (37 feet) including 75 joints were available in this study.
Results:
A high bony union rate was achieved as of 97.3% in 73 out of 75 joints. Nonunion was seen in two patients including two joints: one for 1st TMT joint and the other for medial NC joint. There was no delayed union in this study. Time to radiographic union was 10.5 +- 1.9 (range, 7-15) weeks. A total of five postoperative complications were noted. All of them were related to hardware irritation, and all five patients underwent removal of hardware procedure. There was no major complication such as infection during the follow-up period. Of the two nonunion patients, only one with medial NC joint nonunion underwent a revision arthrodesis surgery.
Conclusion:
Based on our results, the fixation construct of compression plate with lag screw augmenting with highly porous β - tricalcium phosphate (β - TCP) and bone marrow aspirate concentrate (BMAC) is safe and effective for midfoot joint arthrodesis with an excellent union rate and a low complication rate.
Category:
Midfoot/Forefoot
Introduction/Purpose:
Nonunion is one of the most common and devastating complications following midfoot joint arthrodesis. Many different types of bone grafts and bone ...substitutes have been used to promote osseous fusion. However, there is no consensus on the gold standard bone grafting material and whether biologic materials should be used alone or in combination. The purpose of this study is to investigate the efficiency of highly porous β-tricalcium phosphate (β-TCP) with Bone Marrow Aspirate Concentrate (BMAC) in midfoot joint arthrodesis.
Methods:
This retrospective comparative study included patients who underwent midfoot joint arthrodesis using compression screws from January 2014 to May 2019. A total of 44 patients (46 feet) including 89 joints were included in this study. The cohort was then stratified into two groups: 25 patients (26 feet) in arthrodesis with highly porous β-TCP and BMAC (group A) and 19 patients (20 feet) in arthrodesis without highly porous β-TCP and BMAC (group B). The osseous union rate was compared between the two groups. Demographic and operative data including age, sex, body mass index (BMI), smoking, etiology of arthritis, comorbidities such as diabetes mellitus and rheumatoid arthritis, number of joints fixed, use of bone graft or bone substitute, and postoperative midfoot anatomic alignment in the two groups were compared.
Results:
There was a significant difference in the union rate between the two groups: 91.5 % (43 out of 47 joints) in arthrodesis with highly porous β-TCP and BMAC (group A) and 76.2 % (32 out of 42 joints) in arthrodesis without highly porous β-TCP and BMAC (group B) (P = 0.048). During the follow-up period, a total of four postoperative complications were reported in this study. In group A, two patients developed hardware irritation, and all of them underwent removal of hardware procedure. In group B, one patient had a superficial wound infection, which was resolved completely without further treatment. The other patient in group B developed a deep wound infection with dehiscence, and it was managed with irrigation and debridement followed by vacuum assisted wound closure therapy.
Conclusion:
This study investigated the efficiency of highly porous β-TCP and BMAC to promote bony healing in midfoot joint arthrodesis. A significantly higher union rate was shown when arthrodesis was performed with highly porous β-TCP and BMAC compared to arthrodesis without them, suggesting that highly porous β-TCP and BMAC can be a viable and effective adjunct to the fixation in midfoot joint arthrodesis.
Category:
Sports; Basic Sciences/Biologics
Introduction/Purpose:
Achilles tendon ruptures have increased 10-fold in the past three decades, leading to long-term functional deficits in nearly ...two-thirds of patients. To counter this, rehabilitation protocols have been developed to strike a balance between protecting the healing tendon from re-rupture while allowing patients to return to activities of daily living as early as possible. However, Achilles tendon loading is neither prescribed nor quantified during immobilization and there is no standardized method of immobilization. Therefore, the purpose of this study was to quantify the amount of tendon loading experienced while walking in 3 different kinds immobilizing boot with respect to prescribed ankle angle and walking speed.
Methods:
Two healthy-young adults (2M; Age: 29.6 +- 2.3 y/o; BMI: 30 +- 7) walked over flat ground while wearing 3 different immobilizing boots and athletic shoes after providing written informed consent in this IRB approved study. We calculated Achilles tendon loading while subjects walked in 3 boots that positioned the ankle in 30 degrees of plantar flexion (Figure A, Air Cam Walker, United Ortho; AirSelect Walker, Aircast, VACOped, OPED). In all three boots, an instrumented insole (Loadsol, Novel) was placed under the foot to quantify load experienced by the tendon. We calculated the Achilles tendon loading profiles during gait for each immobilizing boot and compared them against the normal shod condition. We also provided the surgical repair threshold of 0.5 bodyweights to visualize the potential efficacy of each immobilizing boot for early rehabilitation when the tendon is early in the healing phase.
Results:
As expected, tendon loading was highest in the shod condition with no ankle bracing and lowest in the fully plantarflexed adjustable boot (Figure B). On average, the immobilizing boots reduced tendon loading decreased by 68% compared to unsupported walking in shoes but there were differences among the boots. The 3 different immobilizing boots provided differing levels of support. The 2 walking boots that use heel wedges to support the ankle in plantar flexion provided the least support, reducing loading by an average of 60-68%. The more rigid boot that constrained ankle angle using a posterior strut reduced tendon loading by 77% compared to gait in a normal walking shoe. Based on biomechanical studies of Achilles tendon repair strength in cadaveric experiments, only the rigid boot with the posterior strut reduced tendon loading biomechanics to levels that could be resisted by the surgical repair (Figure B).
Conclusion:
In this study, we used an instrumented insole to quantify Achilles tendon loading in a variety of immobilizing boots used by rupture patients. Our initial findings show that tendon loading is varies greatly between boot types and patients, highlighting the importance of understanding how these loads change in patients. Our future work centers around identifying the tendon loading profiles that promote tendon healing and optimize patient outcomes. These loading profiles will then provide the quantitative data needed to personalize loading for patients and guide rehabilitation to improve outcomes.
•In sagittal plane bending, plates were less stiff than two-screw constructs.•In torsion and transverse plane bending, both constructs behaved similarly.•Lateral gaps at the joint occurred more ...readily with plates during cyclic loading.•Talonavicular fusion constructs must maintain contact across the articular surface.
This study compared stiffness between two constructs for talonavicular arthrodesis: a dorsomedial plating system and two partially threaded cannulated cancellous screws. We hypothesized that the plate would exhibit greater stiffness and resistance to deformation during cyclic loading.
The constructs were implanted in eight matched pairs of cadaveric feet and subjected to axial torsion, cantilever bending in two directions, and cyclic loading to failure.
The two-screw constructs were significantly stiffer in plantar-dorsal bending (p = .025) and trended towards a higher number of cycles before failure than the plate group (p = .087). No significant differences were observed in internal torsion (p = .620), external torsion (p = .165), or medial-lateral bending (p = .686).
This study provided the first biomechanical assessment of a plating system with an integrated compression screw, which was significantly less stiff than a two-screw construct when loaded from plantar to dorsal.
Category:
Bunion; Midfoot/Forefoot
Introduction/Purpose:
The majority of hallux valgus corrections are performed via a two dimensional approach with 1st metatarsal osteotomy and translation in the ...transverse plane. This approach has demonstrated high long-term recurrence rates. Recent research demonstrates that 87% of hallux valgus deformities are three-dimensional with abnormal frontal-plane rotation of the metatarsal, which cannot be completely addressed with a two dimensional metatarsal osteotomy alone. While correction at the 1st tarsometatarsal (TMT) joint may provide the optimal surgical approach for 3D anatomic restoration at the apex of the deformity, 1st TMT fusion historically entails an extended period of non-weightbearing. This study evaluated the clinical, radiographic, and patient-reported outcomes in patients undergoing instrumented triplanar 1st TMT arthrodesis (TMTA) with a biplanar plating system and protected near-immediate weightbearing.
Methods:
This is a prospective multicenter study that will continue for 60 months post-operatively. Patients between 14-58 years old with symptomatic hallux valgus (intermetatarsal and hallux valgus angles between 10.0-22.0° and 16.0-40.0°, respectively) and no prior hallux valgus surgery on the operative foot were eligible for this study. Patients were treated with an instrumented TMTA procedure using a biplanar plating system with protected near-immediate weightbearing. Several outcomes (radiographic, return to weightbearing and activities, pain measured by visual analog scale (VAS), Manchester-Oxford Foot Questionnaire (MOxFQ), and Patient Reported Outcomes Measurement Information System (PROMIS)) were evaluated post-operatively. Two independent fellowship trained musculoskeletal radiologists reviewed all radiographic data. These interim results are limited to patients completing at least 6 months of follow-up.
Results:
165 patients underwent TMTA with at least 6 months follow-up (mean (SD): 17.8 (7.7); min, max: 5.8, 37.3). Mean age was 41.0 (range:14-58) years; 91.5% of patients were female. Mean (SD) days to protected weightbearing in CAM boot and return to full work were 8.4 (7.7) and 56.8 (45.6), respectively. Significant improvements from baseline in HVA, IMA, and TSP (Table 1), VAS score, MOxFQ and PROMIS domains were observed as early as 6 weeks post-procedure. At 12 months, mean (95% CI) change in VAS was -3.7(-4.0, -3.3); Walking/Standing (MOxFQ) change was -35.2 (-39.6, -30.8); and Physical Function (PROMIS) change was 8.7 (7.1, 10.3). Fifteen (9.1%) patients experienced hardware complications, yet maintained radiographic correction to date. No patients (0/58) with 24 months follow-up have experienced recurrence.
Conclusion:
These interim findings support that TMTA with biplanar plating is successful in correcting the 3D hallux valgus deformity with early return to weightbearing while demonstrating favorable clinical and patient-reported outcomes. Patients exhibited meaningful pain reduction after surgery and were able to return to full, unrestricted work and activities in less than two months, on average. Statistically significant improvements in patients' health-related quality of life were observed at 6 and 12 months, post-operatively. Patients will continue to be followed for up to 60 months with additional evaluations for complications, 24-month recurrence, and patient satisfaction.
Background:
Radiographic examination is a widely used evaluation method in the orthopedic clinic. However, conventional radiography alone does not reflect the dynamic changes between foot and ankle ...segments during gait. Multiple 3-dimensional multisegment foot models (3D MFMs) have been introduced to evaluate intersegmental motion of the foot. In this study, we evaluated the correlation between static radiographic indices and intersegmental foot motion indices.
Methods:
One hundred twenty-five females were tested. Static radiographs of full-leg and anteroposterior (AP) and lateral foot views were performed. For hindfoot evaluation, we measured the AP tibiotalar angle (TiTA), talar tilt (TT), calcaneal pitch, lateral tibiocalcaneal angle, and lateral talcocalcaneal angle. For the midfoot segment, naviculocuboid overlap and talonavicular coverage angle were calculated. AP and lateral talo-first metatarsal angles and metatarsal stacking angle (MSA) were measured to assess the forefoot. Hallux valgus angle (HVA) and hallux interphalangeal angle were measured. In gait analysis by 3D MFM, intersegmental angle (ISA) measurements of each segment (hallux, forefoot, hindfoot, arch) were recorded.
Results:
ISAs at midstance phase were most highly correlated with radiography. Significant correlations were observed between ISA measurements using MFM and static radiographic measurements in the same segment. In the hindfoot, coronal plane ISA was correlated with AP TiTA (P < .001) and TT (P = .018). In the hallux, HVA was strongly correlated with transverse ISA of the hallux (P < .001).
Conclusion:
The segmental foot motion indices at midstance phase during gait measured by 3D MFM gait analysis were correlated with the conventional radiographic indices.
Clinical Relevance:
The observed correlation between MFM measurements at midstance phase during gait and static radiographic measurements supports the fundamental basis for the use of MFM in analysis of dynamic motion of foot segment during gait.
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