Agility LP Ankle Arthroplasty Outcomes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
John G. Anderson, MD, Orthopaedic Associates of Michigan, PC
ClinicalTrials.gov Identifier:
NCT01366872
First received: June 2, 2011
Last updated: November 20, 2012
Last verified: November 2012
Results First Received: October 16, 2012  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Retrospective
Conditions: Rheumatoid Arthritis of Ankle
Osteoarthritis of Ankle
Traumatic Arthritis of Ankle

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Orthopaedic clinical, Agility LP TAA

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Minimum of 2 years post index procedure

Reporting Groups
  Description
Agility LP Total Ankle Arthroplasty Patients who underwent Total Ankle Arthroplasty using the Agility LP device a minimum of 2 years prior to study enrollment.

Participant Flow:   Overall Study
    Agility LP Total Ankle Arthroplasty  
STARTED     50  
COMPLETED     50  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Agility LP Total Ankle Arthroplasty Patients who underwent Total Ankle Arthroplasty using the Agility LP device a minimum of 2 years prior to study enrollment.

Baseline Measures
    Agility LP Total Ankle Arthroplasty  
Number of Participants  
[units: participants]
  50  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     23  
>=65 years     27  
Age  
[units: years]
Mean ± Standard Deviation
  62.1  ± 4.36  
Gender  
[units: participants]
 
Female     27  
Male     23  
Region of Enrollment  
[units: participants]
 
United States     50  



  Outcome Measures
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1.  Primary:   Assessment of Functional Outcomes Following Agility LP Ankle Replacement   [ Time Frame: A Minimum of 2 Years Post Index Procedure ]

Measure Type Primary
Measure Title Assessment of Functional Outcomes Following Agility LP Ankle Replacement
Measure Description Range of Motion - Combined total of dorsiflexion and plantarflexion. Full range of motion is described as 30 degrees or more. Partial limitation is described as 29 to 15 degrees. Range of motion that is less than 15 degrees is described as severely limited.
Time Frame A Minimum of 2 Years Post Index Procedure  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Per surgical history (protocol).

Reporting Groups
  Description
Agility LP Total Ankle Arthroplasty Patients who underwent Total Ankle Arthroplasty using the Agility LP device a minimum of 2 years prior to study enrollment.

Measured Values
    Agility LP Total Ankle Arthroplasty  
Number of Participants Analyzed  
[units: participants]
  50  
Assessment of Functional Outcomes Following Agility LP Ankle Replacement  
[units: Degrees]
Mean ± Standard Deviation
 
Pre-operative range of motion     37.67  ± 2.516  
Post-operative range of motion     37.07  ± 2.511  

No statistical analysis provided for Assessment of Functional Outcomes Following Agility LP Ankle Replacement



2.  Secondary:   Evaluation of Complication and Reoperation Rates   [ Time Frame: A Minimum of 2 Years Post Index Procedure ]

Measure Type Secondary
Measure Title Evaluation of Complication and Reoperation Rates
Measure Description Number of reported complications/reoperations following the index procedure.
Time Frame A Minimum of 2 Years Post Index Procedure  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Per Protocol

Reporting Groups
  Description
Agility LP Total Ankle Arthroplasty Patients who underwent Total Ankle Arthroplasty using the Agility LP device a minimum of 2 years prior to study enrollment.

Measured Values
    Agility LP Total Ankle Arthroplasty  
Number of Participants Analyzed  
[units: participants]
  50  
Evaluation of Complication and Reoperation Rates  
[units: participants]
 
Hardware Complication/Removal     6  
Wound Complication     5  
Revisions and Takedowns     3  
Other Surgical Intervention Related     10  
Other Surgical Intervention Not Related     3  

No statistical analysis provided for Evaluation of Complication and Reoperation Rates



3.  Secondary:   Radiographic Predictors of Implant Failures and Poor Outcomes   [ Time Frame: A Minimum of 2 Years Post Index Procedure ]

Measure Type Secondary
Measure Title Radiographic Predictors of Implant Failures and Poor Outcomes
Measure Description Post-Operative radiographic disposition. Subsidence is described as the component sinking into the bone. Ingrowth is described as the implant components to conform into the tibia and talus.
Time Frame A Minimum of 2 Years Post Index Procedure  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Per protocol, patients who were completely revised were excluded.

Reporting Groups
  Description
Agility LP Total Ankle Arthroplasty Patients who underwent Total Ankle Arthroplasty using the Agility LP device a minimum of 2 years prior to study enrollment.

Measured Values
    Agility LP Total Ankle Arthroplasty  
Number of Participants Analyzed  
[units: participants]
  48  
Radiographic Predictors of Implant Failures and Poor Outcomes  
[units: participants]
 
Talar Subsidence     10  
Tibial Subsidence     1  
Talar & Tibial Subsidence     5  
Ingrowth of Both Components     32  

No statistical analysis provided for Radiographic Predictors of Implant Failures and Poor Outcomes




  Serious Adverse Events
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Time Frame Minimum of 2 years post index procedure
Additional Description Self reported by patient, medical record review

Reporting Groups
  Description
Agility LP Total Ankle Arthroplasty Patients who underwent Total Ankle Arthroplasty using the Agility LP device a minimum of 2 years prior to study enrollment.

Serious Adverse Events
    Agility LP Total Ankle Arthroplasty  
Total, serious adverse events    
# participants affected / at risk     0/0 (0.00%)  




  Other Adverse Events
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Time Frame Minimum of 2 years post index procedure
Additional Description Self reported by patient, medical record review

Frequency Threshold
Threshold above which other adverse events are reported   5%  

Reporting Groups
  Description
Agility LP Total Ankle Arthroplasty Patients who underwent Total Ankle Arthroplasty using the Agility LP device a minimum of 2 years prior to study enrollment.

Other Adverse Events
    Agility LP Total Ankle Arthroplasty  
Total, other (not including serious) adverse events    
# participants affected / at risk     14/50  
Infections and infestations    
Wound Complication * [2]  
# participants affected / at risk     10/50 (20.00%)  
# events     10  
Musculoskeletal and connective tissue disorders    
Hardware Complication * [3]  
# participants affected / at risk     6/50 (12.00%)  
# events     6  
Surgical Revision of Implant * [4]  
# participants affected / at risk     3/50 (6.00%)  
# events     3  
Other Surgical Intervention Related to Index Procedure * [5]  
# participants affected / at risk     10/50 (20.00%)  
# events     10  
* Events were collected by non-systematic assessment
[2] Patient who required wound care beyond the accepted standard of care for resolution.
[3] Painful hardware which required post-surgical removal
[4] Patients who had their initial implant revised or removed.
[5] Patient required surgical intervention



  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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