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

This study has been terminated.
(Protocol halted due to less than anticipated recruitment.)
Sponsor:
Information provided by (Responsible Party):
Greg Berlet, Orthopedic Foot and Ankle Center, Ohio
ClinicalTrials.gov Identifier:
NCT01708187
First received: September 5, 2012
Last updated: September 29, 2016
Last verified: September 2016
Results First Received: April 13, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Tendon Tears
Intervention: Biological: Clarix™1k graft

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Clarix™1k Graft   Control Arm Without Clarix™1k Graft
STARTED   1   1 
COMPLETED   1   0 
NOT COMPLETED   0   1 
Lost to Follow-up                0                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
Total Total of all reporting groups

Baseline Measures
   Clarix™1k Graft   Control Arm Without Clarix™1k Graft   Total 
Overall Participants Analyzed 
[Units: Participants]
 1   1   2 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   1   1   2 
>=65 years   0   0   0 
Gender 
[Units: Participants]
     
Female   1   1   2 
Male   0   0   0 


  Outcome Measures

1.  Primary:   Change in Ankle Pain, Inflammation, Function & Activity Limitation From Baseline to 12 Months   [ Time Frame: Baseline,12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Early termination leading to only one subject completing the trial.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Gregory Berlet, MD
Organization: Orthopedic Foot and Ankle Center
phone: 614-895-8747
e-mail: ofacresearch@orthofootankle.com



Responsible Party: Greg Berlet, Orthopedic Foot and Ankle Center, Ohio
ClinicalTrials.gov Identifier: NCT01708187     History of Changes
Other Study ID Numbers: OH1-12-00396
Study First Received: September 5, 2012
Results First Received: April 13, 2016
Last Updated: September 29, 2016
Health Authority: United States: Institutional Review Board