Management Guidelines for Exactech Total Ankle Tibial Insert Model/Cat Number: 3502103; Serial Number 6900322
Patients with the Exactech total ankle tibial insert model 3502103 (serial number 6900322) require close monitoring for potential tibial component loosening, as tibial component failures occur significantly earlier than talar failures in total ankle replacements.
Assessment Protocol
Initial Evaluation
- Obtain weight-bearing ankle radiographs to assess for:
- Peri-implant lucency (particularly around tibial component)
- Component subsidence
- Alignment issues in the coronal plane
- Signs of loosening
Symptoms to Monitor
- Pain with weight-bearing
- Instability during gait
- Decreased range of motion
- Swelling around the ankle joint
Follow-Up Schedule
Short-term Monitoring
- First follow-up: 2-4 weeks post-identification
- Second follow-up: 3 months
- Regular follow-ups: Every 6 months for the first 2 years
Long-term Monitoring
- Annual radiographic assessment after 2 years if asymptomatic
- More frequent monitoring if any concerning signs develop
Risk Assessment
High-Risk Indicators
- Radiographic evidence of peri-implant lucency (occurs in approximately 20.1% of Exactech Vantage ankles) 1
- Pain with weight-bearing
- Visible malalignment on radiographs
- History of previous implant complications
Management Algorithm
For Asymptomatic Patients
- Regular radiographic monitoring as per follow-up schedule
- Activity modification to reduce excessive loading
- Maintain appropriate footwear with cushioning
For Symptomatic Patients
Radiographic Assessment:
- Standard radiographs to evaluate component position and signs of loosening
- CT scan without IV contrast if radiographs are inconclusive but loosening is suspected 2
Joint Aspiration:
- Perform if infection is suspected
- Send for culture, cell count, and differential 2
Treatment Based on Findings:
- If infection present: Follow appropriate surgical intervention per AAOS guidelines 2
- If aseptic loosening: Consider revision planning
- If no clear etiology: Consider additional imaging or second aspiration
Specific Concerns for This Implant
Tibial Component Issues
- Monitor closely for tibial component loosening, which occurs significantly earlier (mean 1.3 years) than talar component issues (mean 2.3 years) 3
- Tibial component loosening is the most common cause of implant failure in Exactech total ankle replacements 1
Polyethylene Insert Wear
- Assess for signs of polyethylene wear, which can lead to osteolysis
- Tibial post wear damage is primarily determined by implant design and length of implantation 4
Rehabilitation Considerations
Weight-bearing Protocol
- If signs of early loosening are present, consider modified weight-bearing
- For stable implants without concerning signs, full weight-bearing is appropriate
Activity Recommendations
- Avoid high-impact activities
- Begin with walking on compliant surfaces before progressing to harder surfaces 2
- Progress running/high-impact activities only after confirming implant stability
Preventing Complications
Alignment Considerations
- Coronal plane malalignment can alter foot kinematics and plantar pressure distribution 5
- Varus malalignment leads to varus shift and internal rotation of the tibiotalar joint
- Valgus malalignment increases hallux pressure and off-loads lateral metatarsals 5
Implant Survival Optimization
- Maintain appropriate body weight
- Use supportive footwear
- Avoid activities that place excessive rotational forces on the ankle
When to Consider Revision
Absolute Indications
- Progressive component loosening
- Periprosthetic infection
- Significant malalignment causing symptoms
- Component failure
Relative Indications
- Persistent pain despite conservative management
- Progressive peri-implant lucency without frank loosening
- Functional limitations affecting quality of life
Important Caveats
Tibial component failures occur earlier than talar failures in total ankle replacements, so early vigilance is crucial 3
Revision outcomes for tibial-only failures (95.5% survival) are significantly better than for talar or combined failures (approximately 75% failure rate) 3
Early detection of complications is essential as delayed intervention may lead to more complex revisions with poorer outcomes
Coronal plane malalignment can significantly affect foot mechanics and should be carefully assessed 5