Trial Outcomes & Findings for Agility LP Ankle Arthroplasty Outcomes (NCT NCT01366872)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

50 participants

Primary outcome timeframe

A Minimum of 2 Years Post Index Procedure

Results posted on

2012-12-20

Participant Flow

Orthopaedic clinical, Agility LP TAA

Minimum of 2 years post index procedure

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	50
Overall Study COMPLETED	50
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Agility LP Ankle Arthroplasty Outcomes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Agility LP Total Ankle Arthroplasty n=50 Participants Patients who underwent Total Ankle Arthroplasty using the Agility LP device a minimum of 2 years prior to study enrollment.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=5 Participants
Age, Categorical >=65 years	27 Participants n=5 Participants
Age Continuous	62.1 years STANDARD_DEVIATION 4.36 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants
Region of Enrollment United States	50 participants n=5 Participants

PRIMARY outcome

Timeframe: A Minimum of 2 Years Post Index Procedure

Population: Per surgical history (protocol).

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.

Outcome measures

Outcome measures
Measure	Agility LP Total Ankle Arthroplasty n=50 Participants Patients who underwent Total Ankle Arthroplasty using the Agility LP device a minimum of 2 years prior to study enrollment.
Assessment of Functional Outcomes Following Agility LP Ankle Replacement Pre-operative range of motion	37.67 Degrees Standard Deviation 2.516
Assessment of Functional Outcomes Following Agility LP Ankle Replacement Post-operative range of motion	37.07 Degrees Standard Deviation 2.511

SECONDARY outcome

Timeframe: A Minimum of 2 Years Post Index Procedure

Population: Per Protocol

Number of reported complications/reoperations following the index procedure.

Outcome measures

Outcome measures
Measure	Agility LP Total Ankle Arthroplasty n=50 Participants Patients who underwent Total Ankle Arthroplasty using the Agility LP device a minimum of 2 years prior to study enrollment.
Evaluation of Complication and Reoperation Rates Hardware Complication/Removal	6 participants
Evaluation of Complication and Reoperation Rates Wound Complication	5 participants
Evaluation of Complication and Reoperation Rates Revisions and Takedowns	3 participants
Evaluation of Complication and Reoperation Rates Other Surgical Intervention Related	10 participants
Evaluation of Complication and Reoperation Rates Other Surgical Intervention Not Related	3 participants

SECONDARY outcome

Timeframe: A Minimum of 2 Years Post Index Procedure

Population: Per protocol, patients who were completely revised were excluded.

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.

Outcome measures

Outcome measures
Measure	Agility LP Total Ankle Arthroplasty n=48 Participants Patients who underwent Total Ankle Arthroplasty using the Agility LP device a minimum of 2 years prior to study enrollment.
Radiographic Predictors of Implant Failures and Poor Outcomes Talar Subsidence	10 participants
Radiographic Predictors of Implant Failures and Poor Outcomes Tibial Subsidence	1 participants
Radiographic Predictors of Implant Failures and Poor Outcomes Talar & Tibial Subsidence	5 participants
Radiographic Predictors of Implant Failures and Poor Outcomes Ingrowth of Both Components	32 participants

Adverse Events

Agility LP Total Ankle Arthroplasty

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Agility LP Total Ankle Arthroplasty n=50 participants at risk Patients who underwent Total Ankle Arthroplasty using the Agility LP device a minimum of 2 years prior to study enrollment.
Musculoskeletal and connective tissue disorders Hardware Complication	12.0% 6/50 • Number of events 6 • Minimum of 2 years post index procedure Self reported by patient, medical record review
Infections and infestations Wound Complication	20.0% 10/50 • Number of events 10 • Minimum of 2 years post index procedure Self reported by patient, medical record review
Musculoskeletal and connective tissue disorders Surgical Revision of Implant	6.0% 3/50 • Number of events 3 • Minimum of 2 years post index procedure Self reported by patient, medical record review
Musculoskeletal and connective tissue disorders Other Surgical Intervention Related to Index Procedure	20.0% 10/50 • Number of events 10 • Minimum of 2 years post index procedure Self reported by patient, medical record review

Additional Information

Dr. John G. Anderson

Orthopaedic Associates of Michigan, PC

Phone: 616-459-7101

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place