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Compression Treatment Effects on Complications and Healing of Achilles Tendon Rupture

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01317160
First Posted: March 17, 2011
Last Update Posted: September 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Stockholm County Council, Sweden
DJO Incorporated
Information provided by (Responsible Party):
Paul Ackermann, Karolinska University Hospital
Results First Submitted: January 18, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Care Provider, Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Rupture
Venous Thromboembolism
Venous Thrombosis
Surgical Wound Infection
Intervention: Device: Intermittent pneumatic compression (IPC)

  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
Routine Care: Plaster Cast Treatment Two weeks of postoperative conventional lower limb plaster cast immobilization in 30 degrees of plantarflexion
Intermittent Pneumatic Compression (IPC)

Two weeks of calf IPC by Aircast® VenaFlow® Elite System during immobilization in an orthosis Aicast® XP Walker.

Intermittent pneumatic compression (IPC): 6 hours IPC, daily, applied to both calves during two weeks post-operatively. The VenaFlow Elite system (Aircast, Vista, California) uses calf cuffs containing two overlapping air chambers located posteriorly on the leg. As the device cycles, the distal chamber inflates to 52 mm Hg over half a second. During the last 0.2 second of this period, the proximal chamber inflates and reaches 45 mm Hg. After six seconds of inflation the cuff deflates, and the cycle is repeated every minute.


Participant Flow:   Overall Study
    Routine Care: Plaster Cast Treatment   Intermittent Pneumatic Compression (IPC)
STARTED   75   75 
Allocation to Treatment   74 [1]   74 [1] 
COMPLETED   71   69 
NOT COMPLETED   4   6 
Incorrect inclusion                1                1 
Lost to Follow-up                3                3 
Withdrawal by Subject                0                2 
[1] 1 patient was incorrect included



  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
Routine Care: Plaster Cast Treatment Two weeks of postoperative conventional lower limb plaster cast immobilization in 30 degrees of plantarflexion
Intermittent Pneumatic Compression (IPC)

Two weeks of calf IPC by Aircast® VenaFlow® Elite System during immobilization in an orthosis Aicast® XP Walker.

Intermittent pneumatic compression (IPC): 6 hours IPC, daily, applied to both calves during two weeks post-operatively. The VenaFlow Elite system (Aircast, Vista, California) uses calf cuffs containing two overlapping air chambers located posteriorly on the leg. As the device cycles, the distal chamber inflates to 52 mm Hg over half a second. During the last 0.2 second of this period, the proximal chamber inflates and reaches 45 mm Hg. After six seconds of inflation the cuff deflates, and the cycle is repeated every minute.

Total Total of all reporting groups

Baseline Measures
   Routine Care: Plaster Cast Treatment   Intermittent Pneumatic Compression (IPC)   Total 
Overall Participants Analyzed 
[Units: Participants]
 71   69   140 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      70  98.6%      69 100.0%      139  99.3% 
>=65 years      1   1.4%      0   0.0%      1   0.7% 
Age 
[Units: Years]
Mean (Full Range)
 39.9 
 (18 to 71) 
 40.9 
 (26 to 62) 
 40.4 
 (18 to 71) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      13  18.3%      8  11.6%      21  15.0% 
Male      58  81.7%      61  88.4%      119  85.0% 
Region of Enrollment 
[Units: Participants]
     
Sweden   71   69   140 
Tobacco user 
[Units: Participants]
     
Tobacco user: Yes   8   5   13 
Tobacco user: No   63   64   127 
Body mass index 
[Units: Kg/m/m]
Mean (Full Range)
 26.7 
 (20.2 to 35.7) 
 27.1 
 (21 to 41.2) 
 26.9 
 (20.2 to 41.2) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Venous Thromboembolic Events (VTE)   [ Time Frame: 2 weeks ]

2.  Secondary:   Venous Thromboembolic Events (VTE)   [ Time Frame: 6 weeks ]

3.  Secondary:   Functional Outcome - Muscular Endurance Tests (Heel-rise)   [ Time Frame: one year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Patient-reported Outcome and Physical Activity   [ Time Frame: One year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   Microdialysis   [ Time Frame: 2 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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
No text entered.


  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: Dr. Paul W. Ackermann
Organization: Karolinska university Hospital
phone: +46851770000
e-mail: paul.ackermann@karolinska.se


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Paul Ackermann, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT01317160     History of Changes
Other Study ID Numbers: IPC-Achilles
SLL20100168 ( Other Grant/Funding Number: ALF - Stockholm County Council and Karolinska Institutet )
First Submitted: March 16, 2011
First Posted: March 17, 2011
Results First Submitted: January 18, 2016
Results First Posted: March 15, 2016
Last Update Posted: September 14, 2017