Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Prospective Study on Artelon® Tissue Reinforcement in Repair of Chronic Ruptures and Re-ruptures of the Achilles Tendon

This study has been terminated.
(Sponsoring company declared bankrupty)
Sponsor:
Collaborator:
Artimplant AB
Information provided by (Responsible Party):
Orthopedic Foot and Ankle Center, Ohio
ClinicalTrials.gov Identifier:
NCT01237613
First received: September 16, 2010
Last updated: June 29, 2015
Last verified: June 2015
Results First Received: May 8, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Achilles Tendon Rupture
Intervention: Device: Artelon

  Participant Flow
  Hide Participant Flow

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
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


Participant Flow:   Overall Study
    Artelon  
STARTED     4  
COMPLETED     4  
NOT COMPLETED     0  



  Baseline Characteristics
  Hide Baseline Characteristics

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
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


Baseline Measures
    Artelon  
Number of Participants  
[units: participants]
  4  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     4  
>=65 years     0  
Age  
[units: years]
Mean (Full Range)
  54  
  (38 to 63)  
Gender  
[units: participants]
 
Female     2  
Male     2  
Region of Enrollment  
[units: participants]
 
United States     4  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   The Foot Function Index (FFI) for Evaluation of Foot Pain and Disability   [ Time Frame: 3 months ]

2.  Primary:   The Foot Function Index (FFI) for Evaluation of Foot Pain and Disability   [ Time Frame: 6 months ]

3.  Primary:   The Foot Function Index (FFI) for Evaluation of Foot Pain and Disability   [ Time Frame: 12 months ]

4.  Secondary:   The American Orthopaedic Foot and Ankle Society (AOFAS) Clinical Rating System for Ankle-hindfoot   [ Time Frame: 3 months ]

5.  Secondary:   General Measure of Health-related Quality of Life Using the EuroQoL (EQ-5D) Questionnaire   [ Time Frame: 3 months ]

6.  Secondary:   Range of Motion, Strength and Calf Circumference   [ Time Frame: 3 months ]

7.  Secondary:   Subjective Evaluation of Treatment   [ Time Frame: 3 months ]

8.  Secondary:   Return to Work and Previous Physical Activities   [ Time Frame: 3 months ]

9.  Secondary:   Clinical Evaluation Including Adverse Events   [ Time Frame: 3 months ]

10.  Secondary:   The American Orthopaedic Foot and Ankle Society (AOFAS) Clinical Rating System for Ankle-hindfoot   [ Time Frame: 6 months ]

11.  Secondary:   General Measure of Health-related Quality of Life Using the EuroQoL (EQ-5D) Questionnaire   [ Time Frame: 6 months ]

12.  Secondary:   Range of Motion, Strength and Calf Circumference   [ Time Frame: 6 months ]

13.  Secondary:   Subjective Evaluation of Treatment   [ Time Frame: 6 months ]

14.  Secondary:   Return to Work and Previous Physical Activities   [ Time Frame: 6 months ]

15.  Secondary:   Clinical Evaluation Including Adverse Events   [ Time Frame: 6 months ]

16.  Secondary:   The American Orthopaedic Foot and Ankle Society (AOFAS) Clinical Rating System for Ankle-hindfoot   [ Time Frame: 12 months ]

17.  Secondary:   General Measure of Health-related Quality of Life Using the EuroQoL (EQ-5D) Questionnaire   [ Time Frame: 12 months ]

18.  Secondary:   Range of Motion, Strength and Calf Circumference   [ Time Frame: 12 months ]

19.  Secondary:   Subjective Evaluation of Treatment   [ Time Frame: 12 months ]

20.  Secondary:   Return to Work and Previous Physical Activities   [ Time Frame: 12 months ]

21.  Secondary:   Clinical Evaluation Including Adverse Events   [ Time Frame: 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
The sample size is small due to the study being terminated early because of sponsor bankrupty,


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Terrence M. Philbin, DO
Organization: Orthopedic Foot and Ankle Center
phone: 614-895-8747 ext 111
e-mail: ofacresearch@orthofootankle.com



Responsible Party: Orthopedic Foot and Ankle Center, Ohio
ClinicalTrials.gov Identifier: NCT01237613     History of Changes
Other Study ID Numbers: KP027ext
Study First Received: September 16, 2010
Results First Received: May 8, 2015
Last Updated: June 29, 2015
Health Authority: United States: Institutional Review Board