Trial Outcomes & Findings for The Role of C-HAM in the Surgical Repair of Peroneal Tendons: An Infrared Thermography Model (NCT NCT01708187)

Last Updated: 2016-11-03

Results Overview

Ankle pain measured via visual analog scale (VAS), function measured by American Orthopaedic Foot and Ankle Society (AOFAS) ankle hindfoot scale and Foot Function Index (FFI), activity limitation measured by AOFAS scale. Images taken via thermal camera to measure inflammation were not interpretable. VAS pain scale: 0-100, with a lower number representing a better score FFI scale: 0-100, with a lower number representing a better score AOFAS scale: 0-100, with a higher number representing a better score

Recruitment status

TERMINATED

Study phase

Target enrollment

2 participants

Primary outcome timeframe

Baseline,12 months

Results posted on

2016-11-03

Participant Flow

Participant milestones

Participant milestones
Measure	Clarix™1k Graft Group 1 received standard peroneal repair surgery with the addition of the Clarix™1k tissue.	Control Arm Without Clarix™1k Graft Group 2 received standard peroneal repair surgery without the use of the Clarix™1k tissue.
Overall Study STARTED	1	1
Overall Study COMPLETED	1	0
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Clarix™1k Graft Group 1 received standard peroneal repair surgery with the addition of the Clarix™1k tissue.	Control Arm Without Clarix™1k Graft Group 2 received standard peroneal repair surgery without the use of the Clarix™1k tissue.
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

The Role of C-HAM in the Surgical Repair of Peroneal Tendons: An Infrared Thermography Model

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Clarix™1k Graft n=1 Participants Group 1 received standard peroneal repair surgery with the addition of the Clarix™1k tissue.	Control Arm Without Clarix™1k Graft n=1 Participants Group 2 received standard peroneal repair surgery without the use of the Clarix™1k tissue.	Total n=2 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline,12 months

Outcome measures

Outcome measures
Measure	Clarix™1k Graft n=1 Participants Group 1 received standard peroneal repair surgery with the addition of the Clarix™1k tissue.	Control Arm Without Clarix™1k Graft Group 2 received standard peroneal repair surgery without the use of the Clarix™1k tissue.
Change in Ankle Pain, Inflammation, Function & Activity Limitation From Baseline to 12 Months VAS pain at Baseline	66 units on a scale	—
Change in Ankle Pain, Inflammation, Function & Activity Limitation From Baseline to 12 Months Change in VAS pain from Baseline to 12 months	-66 units on a scale	—
Change in Ankle Pain, Inflammation, Function & Activity Limitation From Baseline to 12 Months FFI at Baseline	61.76 units on a scale	—
Change in Ankle Pain, Inflammation, Function & Activity Limitation From Baseline to 12 Months Change in FFI from Baseline to 12 months	-57.05 units on a scale	—
Change in Ankle Pain, Inflammation, Function & Activity Limitation From Baseline to 12 Months AOFAS at Baseline	70 units on a scale	—
Change in Ankle Pain, Inflammation, Function & Activity Limitation From Baseline to 12 Months AOFAS at 12 months	90 units on a scale	—
Change in Ankle Pain, Inflammation, Function & Activity Limitation From Baseline to 12 Months Change in AOFAS from Baseline to 12 months	20 units on a scale	—
Change in Ankle Pain, Inflammation, Function & Activity Limitation From Baseline to 12 Months VAS pain at 12 months	0 units on a scale	—
Change in Ankle Pain, Inflammation, Function & Activity Limitation From Baseline to 12 Months FFI at 12 months	4.71 units on a scale	—

Adverse Events

Clarix™1k Graft

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Control Arm Without Clarix™1k Graft

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Clarix™1k Graft n=1 participants at risk Group 1 received standard peroneal repair surgery with the addition of the Clarix™1k tissue.	Control Arm Without Clarix™1k Graft n=1 participants at risk Group 2 received standard peroneal repair surgery without the use of the Clarix™1k tissue.
Skin and subcutaneous tissue disorders Herpes Zoster	100.0% 1/1 • Number of events 1	0.00% 0/1

Additional Information

Gregory Berlet, MD

Orthopedic Foot and Ankle Center

Phone: 614-895-8747

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place