Trial Outcomes & Findings for BioFiber Scaffold Post-Market Observational Study (NCT NCT01849458)

NCT ID: NCT01849458

Last Updated: 2017-06-22

Results Overview

The primary objective is to report the number of participants with device associated adverse events. Device associated adverse events are defined as adverse events that are classified as possibly or definitely related to the study product or procedure, or anticipated adverse events listed in the product's Instruction for Use regardless of relationship to the study device.

• Recruitment status: COMPLETED
• Target enrollment: 50 participants
• Primary outcome timeframe: 12 Months
• Results posted on: 2017-06-22

Participant Flow

Unit of analysis: Single arm

Participant milestones

Measure	BioFiber Scaffold Single arm of subjects implanted with BioFiber Scaffold or BioFiber-CM Scaffold
Overall Study STARTED	50 50
Overall Study 6 Months Follow-up	50 50
Overall Study COMPLETED	46 46
Overall Study NOT COMPLETED	4 4

Reasons for withdrawal

Measure	BioFiber Scaffold Single arm of subjects implanted with BioFiber Scaffold or BioFiber-CM Scaffold
Overall Study Lost to Follow-up	4

Baseline Characteristics

BioFiber Scaffold Post-Market Observational Study

Baseline characteristics by cohort

Measure	BioFiber n=50 Arms Subjects implanted with BioFiber Scaffold or BioFiber-CM Scaffold
Age, Continuous	61.2 years STANDARD_DEVIATION 6.9 • 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	39 participants n=5 Participants
Region of Enrollment France	11 participants n=5 Participants
BMI	27.9 kg/m^2 STANDARD_DEVIATION 7 • n=5 Participants

PRIMARY outcome

Timeframe: 12 Months

The primary objective is to report the number of participants with device associated adverse events.

Device associated adverse events are defined as adverse events that are classified as possibly or definitely related to the study product or procedure, or anticipated adverse events listed in the product's Instruction for Use regardless of relationship to the study device.

Outcome measures

Measure	BioFiber n=46 Participants Subjects implanted with BioFiber Scaffold or BioFiber-CM Scaffold
Number of Participants With Device Associated Adverse Events	4 Participants

SECONDARY outcome

Timeframe: 6 Months

Population: 50 Participants

Evaluate clinical functional outcome Adjusted Constant-Murley Score. The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient.[1] The Constant-Murley score was introduced to determine the functionality after the treatment of a shoulder injury. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points). The higher the score, the higher the quality of the function. A score of 0 is considered the worst outcome and 100 is considered the best outcome.

Outcome measures

Measure	BioFiber n=50 Participants Subjects implanted with BioFiber Scaffold or BioFiber-CM Scaffold
Clinical Functional Outcome - Adjusted Constant-Murley Score	93.4 scores on a scale Standard Deviation 17.5

SECONDARY outcome

Timeframe: 12 Month

Evaluate clinical functional outcome Adjusted Constant-Murley Score. The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient.[1] The Constant-Murley score was introduced to determine the functionality after the treatment of a shoulder injury. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points). The higher the score, the higher the quality of the function. A score of 0 is considered the worst outcome and 100 is considered the best outcome.

Outcome measures

Measure	BioFiber n=46 Participants Subjects implanted with BioFiber Scaffold or BioFiber-CM Scaffold
Clinical Functional Outcome - Adjusted Constant-Murley Score	97.1 scores on a scale Standard Deviation 16.1

SECONDARY outcome

Timeframe: 6 Months

Population: One subject is missing data for this outcome measure thus a total of 49 subjects were analyzed in this section.

Evaluate clinical functional outcome WORC Index. This is a quality-of-life measurement specific for rotator cuff disease based on 21 questions answered using visual analog scales. It is organized in 5 subscales: physical symptoms, sprots/recreation, work, lifestyle, and emotions. Each item has a possible score from 0-100 where higher scores represent a lower quality of life. The scores are summed up to a possible 2100 points. The total number of points is subtracted from 2100, divided by 2100, then multiplied by 100 to create a percentage. The final score is thus a percentage ranging from 0 to 100 with higher percentages indicating better quality of life.

Outcome measures

Measure	BioFiber n=49 Participants Subjects implanted with BioFiber Scaffold or BioFiber-CM Scaffold
Clinical Functional Outcome - WORC Index	80.7 Percentage of WORC Index Standard Deviation 18.9

SECONDARY outcome

Timeframe: 12 Months

Evaluate clinical functional outcome WORC Index. This is a quality-of-life measurement specific for rotator cuff disease based on 21 questions answered using visual analog scales. It is organized in 5 subscales: physical symptoms, sprots/recreation, work, lifestyle, and emotions. Each item has a possible score from 0-100 where higher scores represent a lower quality of life. The scores are summed up to a possible 2100 points. The total number of points is subtracted from 2100, divided by 2100, then multiplied by 100 to create a percentage. The final score is thus a percentage ranging from 0 to 100 with higher percentages indicating better quality of life.

Outcome measures

Measure	BioFiber n=46 Participants Subjects implanted with BioFiber Scaffold or BioFiber-CM Scaffold
Clinical Functional Outcome - WORC Index	86.8 Percentage of WORC Index Standard Deviation 16.3

SECONDARY outcome

Timeframe: 6 Months

Assess re-tears of the repaired tendon using ultrasound imaging. The definition of a re-tear for the rate reported is any full thickness tear in a tendon that was repaired with the BioFiber Scaffold that is at least 80% of the size of the original tear.

Outcome measures

Measure	BioFiber n=50 Participants Subjects implanted with BioFiber Scaffold or BioFiber-CM Scaffold
Number of Study Participants With Re-tears	2 Participants

SECONDARY outcome

Timeframe: 12 Months

Assess re-tears of the repaired tendon using ultrasound imaging. The definition of a re-tear for the rate reported is any full thickness tear in a tendon that was repaired with the BioFiber Scaffold that is at least 80% of the size of the original tear.

Outcome measures

Measure	BioFiber n=46 Participants Subjects implanted with BioFiber Scaffold or BioFiber-CM Scaffold
Number of Study Participants With Re-tears	2 Participants

Adverse Events

BioFiber

Serious events: 3 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	BioFiber n=50 participants at risk Subjects implanted with BioFiber Scaffold or BioFiber-CM Scaffold
Infections and infestations Infection	2.0% 1/50 • Number of events 1 • 12 Months
Vascular disorders Stroke	2.0% 1/50 • Number of events 1 • 12 Months
Vascular disorders Deep Vein Thrombosis	2.0% 1/50 • Number of events 1 • 12 Months

Other adverse events

Measure	BioFiber n=50 participants at risk Subjects implanted with BioFiber Scaffold or BioFiber-CM Scaffold
Vascular disorders Clot	2.0% 1/50 • Number of events 1 • 12 Months

Additional Information

Marcela Bravo

Tornier Inc.

Phone: 9526837481

Email: marcela.bravo@tornier.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place