Compression Treatment Effects on Complications and Healing of Achilles Tendon Rupture
This trial is active, not recruiting.
|Conditions||rupture, venous thromboembolism, venous thrombosis, surgical wound infection|
|Treatment||intermittent pneumatic compression (ipc)|
|Sponsor||Karolinska University Hospital|
|Collaborator||Stockholm County Council, Sweden|
|Start date||March 2011|
|End date||August 2013|
|Trial size||150 participants|
|Trial identifier||NCT01317160, IPC-Achilles, SLL20100168|
This prospective randomized study aims to determine whether intermittent pneumatic compression (IPC), 75 patients, beneath functional bracing compared to treatment-as-usual in plaster cast, 75 patients, can reduce the Venous Thromboembolism (VTE) incidence and promote healing of sutured acute Achilles tendon ruptures.
At two weeks post surgery, the IPC intervention will be ended and both patient groups will be immobilized in an orthosis until follow-up at six weeks.
The endpoint of the first part of the study is VTE events. The primary outcome will be the DVT-incidence at two weeks, assessed using screening compression duplex ultrasound (CDU) by two ultrasonographers masked to the treatment allocation. Secondary outcome will be the DVT-incidence at 6 weeks.
1) Deep Vein Thrombosis (DVT) detected by CDU , 2) isolated calf muscle vein thrombosis (ICMVT) detected by CDU, 3) symptomatic DVT or ICMVT detected by CDU, 4) symptomatic pulmonary embolism detected by computer tomography.
The endpoint of the second part of the study is tendon healing quantified at 2, 4 and 6 weeks by ultrasound using speckle tracking and by microdialysis followed by quantification of markers for tendon repair.
The endpoint of the third part of the study is the functional outcome of the patients at one year post-operatively using four reliable and valid scores, i.e. the Achilles tendon Total Rupture Score (ATRS), Physical Activity scale (PAS), Foot and Ankle Outcome Score (FAOS) and EuroQol Group's questionnaire (EQ-5D) as well as the validated heel-rise test.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (caregiver, outcomes assessor)|
Venous thromboembolic events (VTE)
time frame: 2 weeks
Functional outcome - muscular endurance tests (heel-rise)
time frame: one year
venous thromboembolic events (VTE)
time frame: 6 weeks
Patient-reported outcome and physical activity
time frame: One year
Male or female participants from 18 years up to 75 years old.
Inclusion Criteria: - Achilles tendon rupture operated on within 96 hours of diagnose. Exclusion Criteria: 1. Inability or refusal to give informed consent for participation in the study 2. Ongoing treatment with anticoagulant therapy 3. Inability to comply with the study instructions 4. Known kidney disorder 5. Heart failure with pitting oedema 6. Thrombophlebitis 7. Recent thromboembolic event (during the preceding 3 months) 8. Recent surgery (during the preceding month) 9. Presence of known malignancy 10. Current bleeding disorder 11. Pregnancy
|Official title||Intermittent Pneumatic Compression Effects on Venous Thromboembolism Incidence and Healing of Achilles Tendon Rupture|
|Principal investigator||Paul W Ackermann, MD, PhD|
|Description||Recently, the incidence of DVT after Achilles tendon rupture was demonstrated as high as 30-40%. Moreover it was demonstrated that low molecular weight heparin had no effect on preventing DVT after Achilles tendon surgery. Whether intermittent pneumatic compression (IPC) can prevent DVTs and improve healing after Achilles tendon rupture has to our knowledge not been tested before.|
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