Trial Outcomes & Findings for Prospective Study on Artelon® Tissue Reinforcement in Repair of Chronic Ruptures and Re-ruptures of the Achilles Tendon (NCT NCT01237613)
NCT ID: NCT01237613
Last Updated: 2015-07-22
Results Overview
TERMINATED
NA
4 participants
3 months
2015-07-22
Participant Flow
Participant milestones
| Measure |
Artelon
This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.
Artelon: Artelon Tissue Reinforcement
|
|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prospective Study on Artelon® Tissue Reinforcement in Repair of Chronic Ruptures and Re-ruptures of the Achilles Tendon
Baseline characteristics by cohort
| Measure |
Artelon
n=4 Participants
This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.
Artelon: Artelon Tissue Reinforcement
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
54 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Data not analyzed as study was terminated due to sponsor bankruptcy.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 6 monthsPopulation: Data not analyzed as study was terminated due to sponsor bankruptcy.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 12 monthsPopulation: Data not analyzed as study was terminated due to sponsor bankruptcy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 monthsPopulation: Data not analyzed as study was terminated due to sponsor bankruptcy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 monthsPopulation: Data not analyzed as study was terminated due to sponsor bankruptcy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 monthsPopulation: Data not analyzed as study was terminated due to sponsor bankruptcy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 monthsPopulation: Data not analyzed as study was terminated due to sponsor bankruptcy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 monthsPopulation: Data not analyzed as study was terminated due to sponsor bankruptcy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 monthsPopulation: Data not analyzed as study was terminated due to sponsor bankruptcy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsPopulation: Data not analyzed as study was terminated due to sponsor bankruptcy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsPopulation: Data not analyzed as study was terminated due to sponsor bankruptcy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsPopulation: Data not analyzed as study was terminated due to sponsor bankruptcy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsPopulation: Data not analyzed as study was terminated due to sponsor bankruptcy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsPopulation: Data not analyzed as study was terminated due to sponsor bankruptcy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsPopulation: Data not analyzed as study was terminated due to sponsor bankruptcy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: Data not analyzed as study was terminated due to sponsor bankruptcy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: Data not analyzed as study was terminated due to sponsor bankruptcy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: Data not analyzed as study was terminated due to sponsor bankruptcy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: Data not analyzed as study was terminated due to sponsor bankruptcy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: Data not analyzed as study was terminated due to sponsor bankruptcy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: Data not analyzed as study was terminated due to sponsor bankruptcy.
Outcome measures
Outcome data not reported
Adverse Events
Artelon
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Artelon
n=4 participants at risk
This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.
Artelon: Artelon Tissue Reinforcement
|
|---|---|
|
Immune system disorders
Sinusitis
|
25.0%
1/4 • Number of events 1
|
|
Gastrointestinal disorders
C-difficile
|
25.0%
1/4 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Influenza
|
25.0%
1/4 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Increased tenderness over left peroneal and posterior tibial tendons
|
25.0%
1/4 • Number of events 1
|
Additional Information
Terrence M. Philbin, DO
Orthopedic Foot and Ankle Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60