Compression Treatment Effects on Complications and Healing of Achilles Tendon Rupture

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Stockholm County Council, Sweden
DJO Incorporated
Information provided by (Responsible Party):
Paul Ackermann, Karolinska University Hospital
ClinicalTrials.gov Identifier:
NCT01317160
First received: March 16, 2011
Last updated: May 29, 2016
Last verified: May 2016
Results First Received: January 18, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Caregiver, 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  
Number of Participants  
[units: participants]
  71     69     140  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     70     69     139  
>=65 years     1     0     1  
Age  
[units: years]
Mean (Full Range)
  39.9  
  (18 to 71)  
  40.9  
  (26 to 62)  
  40.4  
  (18 to 71)  
Gender  
[units: participants]
     
Female     13     8     21  
Male     58     61     119  
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
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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.   Safety Issue:   No

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

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


  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
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  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



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 )
Study First Received: March 16, 2011
Results First Received: January 18, 2016
Last Updated: May 29, 2016
Health Authority: Sweden: Regional Ethical Review Board