Compression Treatment Effects on Complications and Healing of Achilles Tendon Rupture
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Purpose
This multicenter randomized study aims to determine whether intermittent pneumatic compression (IPC), 50 patients, and functional bracing compared to conventional plaster cast treatment, 50 patients, can reduce the Venous Thromboembolism (VTE) incidence and promote healing of sutured acute Achilles tendon ruptures.
The primary endpoint is VTE events evaluated at 2 and 6 weeks post-surgery:
1) Deep Vein Thrombosis (DVT) detected by duplex-colorcoded ultrasound (CUS), 2) isolated calf muscle vein thrombosis (ICMVT) detected by CUS, 3) symptomatic DVT or ICMVT detected by CUS, 4) symptomatic pulmonary embolism detected by computer tomography.
The secondary endpoint 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.
| Condition | Intervention |
|---|---|
|
Rupture Venous Thromboembolism Venous Thrombosis Surgical Wound Infection |
Device: Intermittent pneumatic compression (VenaFlow Elite system) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Caregiver, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Intermittent Pneumatic Compression Effects on Venous Thromboembolism Incidence and Healing of Achilles Tendon Rupture |
- Adverse events - eg. Venous thromboembolic events [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
At 2 and 6 weeks postoperatively the number of participants with adverse events will be assessed:
A.) Venous thromboembolic events assessed by:
1) DVT detected by duplex-colorcoded ultrasound (CUS), 2) isolated calf muscle vein thrombosis (ICMVT) detected by CUS, 3) symptomatic DVT or ICMVT detected by CUS, 4) symptomatic pulmonary embolism detected by computer tomography.
B.) Post-operative infections
- Tendon healing [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- The number of participants with a re-rupture will be assessed at 6 months and 1 year.
- The functional outcome will be assessed at 12 weeks, 26 weeks and 52 weeks by validated scores, eg. heel rise test and Achilles tendon rupture score.
- Tendon healing quantified at 2 and 6 weeks by ultrasound using speckle tracking and by microdialysis followed by quantification of markers for tendon repair.
| Estimated Enrollment: | 100 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Conventional Plaster Cast Treatment
Two weeks of postoperative conventional lower limb plaster cast immobilization in 30 degrees of plantarflexion
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Experimental: Intermittent pneumatic compression
Two weeks of intermittent pneumatic calf compression applied by Aircast® VenaFlow® Elite System during immobilization in an orthosis Aicast® XP Walker.
|
Device: Intermittent pneumatic compression (VenaFlow Elite system)
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.
Other Names:
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Detailed 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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Achilles tendon rupture operated on within 96 hours of diagnose.
Exclusion Criteria:
- Inability or refusal to give informed consent for participation in the study
- Ongoing treatment with anticoagulant therapy
- Inability to comply with the study instructions
- Known kidney disorder
- Heart failure with pitting oedema
- Thrombophlebitis
- Recent thromboembolic event (during the preceding 3 months)
- Recent surgery (during the preceding month)
- Presence of known malignancy
- Current bleeding disorder
- Pregnancy
Contacts and Locations| Sweden | |
| Karolinska University Hospital | Recruiting |
| Stockholm, Sweden, 17176 | |
| Contact: Luigi Belcastro, RN +46851770000 ext 5678 luigi.belcastro@karolinska.se | |
| Principal Investigator: Erica Arverud, MD | |
| Principal Investigator: | Paul W Ackermann, MD, PhD | Karolinska University Hospital, 171 76 Stockholm, SWEDEN |
More Information
No publications provided
| Responsible Party: | Paul Ackermann / Principal Investigator, Karolinska University Hospital |
| ClinicalTrials.gov Identifier: | NCT01317160 History of Changes |
| Other Study ID Numbers: | IPC-Achilles, SLL20100168 |
| Study First Received: | March 16, 2011 |
| Last Updated: | March 29, 2011 |
| Health Authority: | Sweden: Regional Ethical Review Board |
Keywords provided by Karolinska University Hospital:
|
Achilles Tendon Immobilization Wound Healing |
Intermittent Pneumatic Compression Ultrasonography Microdialysis |
Additional relevant MeSH terms:
|
Surgical Wound Infection Thromboembolism Thrombosis Venous Thrombosis Venous Thromboembolism Wound Infection Rupture |
Infection Postoperative Complications Pathologic Processes Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Wounds and Injuries |
ClinicalTrials.gov processed this record on May 21, 2013