Trial Outcomes & Findings for Wright Foot & Ankle Post-Market Observational Study (NCT NCT04118894)

Results Overview

Comparing the changes in patient-reported pain and social interaction for quality of life from pre-op through post-operatively, assessed by the EuroQol (EQ-5D-5L). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. This decision results in a 1-digit number that expresses the level selected for that dimension. Health utility values generated from the EQ-5D generally range from 0 (death) to 1 (perfect health). But health utility values less than 0 are possible, and represent health states considered worse than death. The EQ VAS records the patient's self-rated health on a VAS (0-100), where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.

Recruitment status

TERMINATED

Target enrollment

119 participants

Primary outcome timeframe

1 year

Results posted on

2025-01-14

Participant Flow

Overall, 119 subjects were enrolled and treated with a study device at 5 sites in the private clinic and hospital setting in the France, Germany, United States and United Kingdom. A subject may have received more than one of the devices under investigation. The first subject was enrolled on January 22, 2020 (aligned with protocol) and the last subject was enrolled on November 1, 2021.

No specific method (such as randomization, blinding or stratification) for assigning subjects was used in this protocol. Consecutive subjects at each site meeting all the eligibility criteria were enrolled in this study.

Participant milestones

Participant milestones
Measure	Foot and Ankle Devices The study subjects included are those treated with one or more approved or cleared Wright Medical products included in this study.
Overall Study STARTED	119
Overall Study COMPLETED	84
Overall Study NOT COMPLETED	35

Reasons for withdrawal

Reasons for withdrawal
Measure	Foot and Ankle Devices The study subjects included are those treated with one or more approved or cleared Wright Medical products included in this study.
Overall Study Lost to Follow-up	21
Overall Study Withdrawal by Subject	10
Overall Study Adverse Event	4

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Foot and Ankle Devices n=119 Participants The study subjects included are those treated with one or more approved or cleared Wright Medical products included in this study.
Age, Continuous	59.49 years STANDARD_DEVIATION 13.34 • n=119 Participants
Sex: Female, Male Female	79 Participants n=119 Participants
Sex: Female, Male Male	40 Participants n=119 Participants
Smoking Status Never	77 Participants n=119 Participants
Smoking Status Previous	38 Participants n=119 Participants
Smoking Status Current, <= 1 Pack/day	3 Participants n=119 Participants
Smoking Status Current, > 1 pack/day	1 Participants n=119 Participants
BMI	28.18 kg/m^2 STANDARD_DEVIATION 5.58 • n=119 Participants

PRIMARY outcome

Timeframe: 1 year

Comparing the changes in patient-reported pain and social interaction for quality of life from pre-op through post-operatively, assessed by the EuroQol (EQ-5D-5L). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. This decision results in a 1-digit number that expresses the level selected for that dimension. Health utility values generated from the EQ-5D generally range from 0 (death) to 1 (perfect health). But health utility values less than 0 are possible, and represent health states considered worse than death. The EQ VAS records the patient's self-rated health on a VAS (0-100), where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.

Outcome measures

Outcome measures
Measure	Foot and Ankle Devices n=84 Participants The study subjects included are those treated with one or more approved or cleared Wright Medical products included in this study.
EuroQol (EQ-5D-5L).	74.1 units on a scale- EQ5D VAS Standard Deviation 22.5

SECONDARY outcome

Timeframe: 1 year

Comparing the changes in patient-reported function scores from pre-op through post-operatively, assessed by the FAAM The FAAM is a patient-completed instrument that consists of an "Activities of Daily Living" subscale (21 scored items) and a "Sports" subscale (7 scored items) in which the response options are presented as 5-point Likert scales (range 4 to 0). Scores for each subscale range from 0% (least function) to 100% (most function).

Outcome measures

Outcome measures
Measure	Foot and Ankle Devices n=82 Participants The study subjects included are those treated with one or more approved or cleared Wright Medical products included in this study.
Foot and Ankle Ability Measure (FAAM)	68.6 score on a scale- FAAM SANE Standard Deviation 25.5

SECONDARY outcome

Timeframe: 1 year

Population: Safety is reported in the adverse event section.

Identifying and reporting the safety of the implant in terms of complications and adverse events. (This is reported in the Adverse Event Section)

Outcome measures

Outcome measures
Measure	Foot and Ankle Devices n=119 Participants The study subjects included are those treated with one or more approved or cleared Wright Medical products included in this study.
Safety Assessment Subjects that Experienced a Serious Adverse Event	9 Participants
Safety Assessment Subjects that Didn't Experience a Serious Adverse Event	110 Participants

SECONDARY outcome

Timeframe: 1 year

Conducting a surgeon survey including radiographic assessment of fusion and consolidation time

Outcome measures

Outcome measures
Measure	Foot and Ankle Devices n=112 Participants The study subjects included are those treated with one or more approved or cleared Wright Medical products included in this study.
Surgeon Survey Wright product performed as intended- Yes	109 Participants
Surgeon Survey Wright product performed as intended- No	3 Participants

SECONDARY outcome

Timeframe: 1 year

Conducting patient surveys to assess current implant status (to include complications)

Outcome measures

Outcome measures
Measure	Foot and Ankle Devices n=49 Participants The study subjects included are those treated with one or more approved or cleared Wright Medical products included in this study.
Patient Survey Experienced any complications associated with your procedure requiring you to seek medical care? · Yes	7 Participants
Patient Survey Experienced any complications associated with your procedure requiring you to seek medical care? · No	42 Participants
Patient Survey Any surgery to remove any device parts associated with your foot/ankle procedure? · Yes	1 Participants
Patient Survey Any surgery to remove any device parts associated with your foot/ankle procedure? · No	48 Participants

Adverse Events

Foot and Ankle Devices

Serious events: 9 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Foot and Ankle Devices n=119 participants at risk The study subjects included are those treated with one or more approved or cleared Wright Medical products included in this study.
Cardiac disorders acute aortic dissection	0.84% 1/119 • Number of events 1 • Surgery to 1 year Procedural and device related events will be described and collected on the AE form. It is the responsibility of the operating surgeon/s to be aware and note the adverse effects from the package insert/instructions for use by the manufacturer/sponsor.
Musculoskeletal and connective tissue disorders Below Knee Amputation	0.84% 1/119 • Number of events 1 • Surgery to 1 year Procedural and device related events will be described and collected on the AE form. It is the responsibility of the operating surgeon/s to be aware and note the adverse effects from the package insert/instructions for use by the manufacturer/sponsor.
Musculoskeletal and connective tissue disorders Infection	3.4% 4/119 • Number of events 5 • Surgery to 1 year Procedural and device related events will be described and collected on the AE form. It is the responsibility of the operating surgeon/s to be aware and note the adverse effects from the package insert/instructions for use by the manufacturer/sponsor.
Musculoskeletal and connective tissue disorders Non-Union	0.84% 1/119 • Number of events 1 • Surgery to 1 year Procedural and device related events will be described and collected on the AE form. It is the responsibility of the operating surgeon/s to be aware and note the adverse effects from the package insert/instructions for use by the manufacturer/sponsor.
Musculoskeletal and connective tissue disorders Pain	1.7% 2/119 • Number of events 2 • Surgery to 1 year Procedural and device related events will be described and collected on the AE form. It is the responsibility of the operating surgeon/s to be aware and note the adverse effects from the package insert/instructions for use by the manufacturer/sponsor.

Other adverse events

Other adverse events
Measure	Foot and Ankle Devices n=119 participants at risk The study subjects included are those treated with one or more approved or cleared Wright Medical products included in this study.
Musculoskeletal and connective tissue disorders Pain	10.1% 12/119 • Number of events 14 • Surgery to 1 year Procedural and device related events will be described and collected on the AE form. It is the responsibility of the operating surgeon/s to be aware and note the adverse effects from the package insert/instructions for use by the manufacturer/sponsor.
Musculoskeletal and connective tissue disorders Algodystrophy	0.84% 1/119 • Number of events 1 • Surgery to 1 year Procedural and device related events will be described and collected on the AE form. It is the responsibility of the operating surgeon/s to be aware and note the adverse effects from the package insert/instructions for use by the manufacturer/sponsor.
Musculoskeletal and connective tissue disorders Blister Dorsal Aspect of Operated Foot	0.84% 1/119 • Number of events 1 • Surgery to 1 year Procedural and device related events will be described and collected on the AE form. It is the responsibility of the operating surgeon/s to be aware and note the adverse effects from the package insert/instructions for use by the manufacturer/sponsor.
Musculoskeletal and connective tissue disorders Inflammatory Scar	0.84% 1/119 • Number of events 1 • Surgery to 1 year Procedural and device related events will be described and collected on the AE form. It is the responsibility of the operating surgeon/s to be aware and note the adverse effects from the package insert/instructions for use by the manufacturer/sponsor.
Musculoskeletal and connective tissue disorders Wound Healing Complications	4.2% 5/119 • Number of events 5 • Surgery to 1 year Procedural and device related events will be described and collected on the AE form. It is the responsibility of the operating surgeon/s to be aware and note the adverse effects from the package insert/instructions for use by the manufacturer/sponsor.
Musculoskeletal and connective tissue disorders Ulcer	0.84% 1/119 • Number of events 1 • Surgery to 1 year Procedural and device related events will be described and collected on the AE form. It is the responsibility of the operating surgeon/s to be aware and note the adverse effects from the package insert/instructions for use by the manufacturer/sponsor.

Additional Information

Jennifer Seidman, Manager, Clinical Research

Stryker

Phone: 9016338616

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place