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Department of Orthopaedic Surgery
Complications of the Tornier Salto Talaris Total Ankle Prosthesis: A Single-Surgeon Experience
Garett Pangrazzi, MD; Erin Baker, MS; Philip Shaheen, BS; Paul Fortin, MD
IFFAS/AOFAS
September 19-23, 2014
Chicago, IL
Department of Orthopaedic Surgery
Complications of the Tornier Salto Talaris Total Ankle Prosthesis: A Single-Surgeon Experience
Garett Pangrazzi, MD My Disclosure is in the final AOFAS Mobile App.
I have no potential conflicts with this presentation.
Paul Fortin, MD My Disclosure is in the final AOFAS Mobile App.
I have a potential conflict with this presentation due to: Paid consultant for Tornier.
Department of Orthopaedic Surgery
Study Objective
• To evaluate postoperative complications encountered with the Salto Talaris total ankle arthroplasty (TAA) system (Tornier US, Bloomington, Minnesota).
Department of Orthopaedic Surgery
Methods
• Review medical records for primary Salto Talaris TAA cases from 2008 - 2013
• Fusion take-downs excluded
• Radiographic Measurements and zones of lucency examined
Pre and postoperative measurements, including tibial angle (TA), tibiotalar angle (TAL), posterior tibial slope (TS), Talocalcaneal angle (TCA)
AP (A) and lateral (B) radiographic zones of lucency as described by Bonnin et al.1 has been modified to include zone 11 (lateral malleolus)
Department of Orthopaedic Surgery
Results: Medical Records Review
Total # Patients
96
Total # Ankles
104 (8 Bilateral)
Sex 48 Male, 48 Female
Average Age 65 (35 – 86)
Body Mass Index (BMI)
29 (17 – 50.3)
Etiology OA = 58; RA = 23;
Posttraumatic = 22; Unknown = 1
Table 1: Patient Demographics
Procedure Frequency
Tendo-Achilles Lengthening (T-AL Only) 77(26)
Prophylactic Medial Malleolus Fixation 34
Hardware Removal 13
Prophylactic ORIF Fibula 12
Lateral Ankle Ligament Reconstruction 11
Subtalar Fusion 11
Calcaneal Osteotomy 9
Talonavicular Fusion 8
Syndesmotic Fusion 5
Midfoot Fusion 3
Hindfoot Fusion 2
1st Metatarsal Osteotomy 2
Other (# of patients) 1 (9)
Table 2: Concurrent Procedures at Primary TAA
Department of Orthopaedic Surgery
Results: Revision & Reoperation Rates
• 29-month average followup (range, 4 – 64)
• 28 complications in 25 ankles
• Reoperation Rates
– 11% overall (11/104)
– 44% (11/25)
• Revision Rate
– 0.96% (1/104)
• 41-month average followup (range, 24 – 69)
• 18 Complications in 16 ankles
• Reoperation Rates
– 10.5% (8/76)
– 50% (8/16)
• Revision Rate
– 1.3% (1/76)
OVERALL (n=104)
2-YEAR FOLLOWUP (n=76)
Diagnostic Complication
Procedure At Reoperation Frequency
Infection Irrigation and Debridement 2
Nonunion (of Fusion) Revision/Hardware Removal 2/1
Pain Revision to InBone TAA (Wright Medical, Arlington, TN)
1
Pain and subsidence Compression Screw 1
Postoperative Bone Fracture
Medial Malleolus ORIF 1
Medial Impingement Ankle Arthroscopy and Exostectomy/Exostectomy Alone
1/1
Wound Healing Debridement and Closure 1
Table 3: Diagnoses/Complication and Procedures at Reoperation and/or Revision TAA
Department of Orthopaedic Surgery
Results: Complication Rate & Types Rate of complication in the study population, according to type, reported via the Glazebrook classification system.2 System has been modified to include uncharacterized pain, nerve palsy and medial impingement (*). The two reports of nerve palsies were associated with popliteal nerve catheter use.
* * *
Rate of reoperation, according to complication type, reported via the Glazebrook classification system.2
Department of Orthopaedic Surgery
Results: ‘Learning Curve’ & Onset of Complications
Rate of complication normalized to number of TAA performed per year.
Time to onset of all complications, based on diagnosis at follow-up visits. The onset of
one subsidence case was unknown.
Department of Orthopaedic Surgery
Results: Identification of “At Risk” Population
• Definition— Radiographic evidence of:
Subsidence
Periprosthetic cystic changes
Periprosthetic Lucency
• 39 patients (38%)
Clinical Example of “at risk” patients. AP (A) and lateral (B) view radiographs of Salto Talaris TAA. This TAA was revised to the In-Bone TAA (C, D). AP (E) and lateral (F) view radiographs of a TAA,
currently defined as “at risk” in our series, exhibiting similar periprosthetic lucency.
Revised “At Risk”
Department of Orthopaedic Surgery
Results: Lucency vs. “Keel Osteopenia”
Zones of lucency for tibial (A) and talar (B) components, based on AP and lateral views.
Zone 11 represents lateral malleolus (lat mal). TAA with radiographic lucency were considered
“at risk”.
AP radiographs demonstrating “keel osteopenia” in two study patients (A, B).
There were 35 patients in this group. They were not considered as being “at risk”.
Department of Orthopaedic Surgery
Radiographic Analysis
Reoperation No reoperation P-Value
TTR 0.29 0.34 0.013
ATA 1.3 2.8 0.019
“At Risk” Not “At Risk” P-Value
TAL 94.4 89.6 0.043
Change in TAL 6.4 0.8 0.015
Keel Osteopenia
No Keel Osteopenia
P-Value
TA 88.9 89.9 0.022
TAL 87.4 89.0 0.003
ATAL 2.9 1.7 0.006
Valgus “At Risk” ǂ
Valgus Not “At Risk” ǂ
P-value
ATAL 12.8 6.7 0.016
Change ATAL 14.1 6.7 0.017
Statistically significant subset analyses. ǂ In valgus preoperatively, and categorized as “at risk” or not “at risk” postoperatively.
Measurement Preoperative Postoperative Change
Tibial Angle (TA) 88.4 (4.6; 75.6 – 99.9)* 89.6 (1.9; 83.5 – 93.8)* 1.2 (4.9; -12.8 – 14.3)
Tibial Angle, Absolute Value (ATA) 3.9 (2.9; 0.1 – 14.4)** 1.4 (1.3; 0.0 – 6.5)** 3.9 (3.1; 0.0 – 14.3)
Tibiotalar Angle (TAL) 91.5 (10.6; 62.1 – 126.5)* 88.5 (2.4; 81.6 – 93.1)* -2.9 (10.5; -42.8 – 28.2)
Tibiotalar Angle, Absolute Value (ATAL) 7.8 (7.3; 0.09 – 36.5)** 2.1 (1.9; 0.0 – 8.4)** 7.8 (7.6; 0.1 – 42.8)
Posterior Tibial Slope (TS) 81.2 (6.1; 61.3 – 99.4)** 85.3 (2.8; 77.0 – 93.8)** 4.0 (6.6; -16.75 – 21.1)
Tibiotalar Ratio (TTR) 0.33 (0.09; 0.09 – 0.54) 0.30 (0.05; 0.20 – 0.49) 0.004 (0.07; -0.19 – 0.19)
Talocalcaneal Angle (TCA) N/A 9.9 (5.6; -12.7 – 21.8) N/A
Table 4: Pre and Postoperative Radiographic Measurements of TAA. *P < 0.05; **P < 0.001
Department of Orthopaedic Surgery
Conclusions & References • Complication rate
– 24%
• Reoperation and revision rate similar to previously reported data3,4 – 11% and 0.96% overall, respectively
• No difference in pre and postoperative radiographic measures… – in ankles that had complications compared to those without complications – in ankles that had at least one concurrent procedure vs. TAA alone
• “At Risk” implants were identified – “At Risk” implants in significantly more valgus preoperatively
• “Keel Osteopenia” – Possibly results from stress shielding phenomenon – Unknown clinical implications, but may change strategy for future revision surgery
References: 1. Bonnin et al. The Salto Total Ankle Arthroplasty. Survivorship and Anyalysis of Failures at 7 to 11 years. CORR.
2011. 469: 225-236. 2. Glazebrook, M. et al. Evidence-Based Classification of Complications in Total Ankle Arthroplasty. Foot Ankle Int.
2009. 30: 945-949 3. Schweitzer et al. Early Prospective Results of the Salto-Talaris Total Ankle Prosthesis. J Bone Joint Surg Am.
95(11): 1002-1011, 2013. 4. Nodzo, SR et al. Short to Midterm Clinical and Radiographic Outcomes of the Salto Total Ankle Prosthesis. Foot
Ankle Int/AOFAS and Swiss Foot and Ankle Society. 2013