Clinical trial NCT01317160: Compression Treatment Effects on Complications and Healing of Achilles Tendon Rupture
Official title: Intermittent Pneumatic Compression Effects on Venous Thromboembolism Incidence and Healing of Achilles Tendon Rupture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rupture
Venous Thromboembolism
Venous Thrombosis
Surgical Wound Infection
Keywords: Achilles Tendon
Immobilization
Wound Healing
Intermittent Pneumatic Compression
Ultrasonography
Microdialysis
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: Region Stockholm
name: DJO Incorporated
First posted: 2011-03-17
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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 weeks 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.

Detailed description: The incidence of DVT after Achilles tendon rupture is as high as 30-40% and patients exhibit a prolonged healing process with variable outcome. Moreover, it has been 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 criteria: 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

Primary outcomes:
measure: Venous Thromboembolic Events (VTE)
timeFrame: 2 weeks
Secondary outcomes:
measure: Functional Outcome - Muscular Endurance Tests (Heel-rise)
timeFrame: one year
measure: Venous Thromboembolic Events (VTE)
timeFrame: 6 weeks
measure: Patient-reported Outcome
timeFrame: One year
measure: Microdialysis
timeFrame: 2 weeks
measure: Time From Injury to Surgery
timeFrame: 1 year
Other outcomes:
measure: Surgeon Sex
timeFrame: Surgery will be performed within 10 days of injury
measure: Surgeon Experience
timeFrame: Surgery will be performed within 10 days of injury
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
affiliation: Karolinska University Hospital, 171 76 Stockholm, SWEDEN
name: Paul W Ackermann, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Domeij-Arverud E, Labruto F, Latifi A, Nilsson G, Edman G, Ackermann PW. Intermittent pneumatic compression reduces the risk of deep vein thrombosis during post-operative lower limb immobilisation: a prospective randomised trial of acute ruptures of the Achilles tendon. Bone Joint J. 2015 May;97-B(5):675-80. doi: 10.1302/0301-620X.97B5.34581.
citation: Abdul Alim M, Domeij-Arverud E, Nilsson G, Edman G, Ackermann PW. Achilles tendon rupture healing is enhanced by intermittent pneumatic compression upregulating collagen type I synthesis. Knee Surg Sports Traumatol Arthrosc. 2018 Jul;26(7):2021-2029. doi: 10.1007/s00167-017-4621-8. Epub 2017 Jul 1.
citation: Chen J, Wang J, Hart DA, Ahmed AS, Ackermann PW. Complement factor D as a predictor of Achilles tendon healing and long-term patient outcomes. FASEB J. 2022 Jun;36(6):e22365. doi: 10.1096/fj.202200200RR.
citation: Svedman S, Juthberg R, Edman G, Ackermann PW. Reduced Time to Surgery Improves Patient-Reported Outcome After Achilles Tendon Rupture. Am J Sports Med. 2018 Oct;46(12):2929-2934. doi: 10.1177/0363546518793655. Epub 2018 Aug 31.
citation: Alim MA, Svedman S, Edman G, Ackermann PW. Procollagen markers in microdialysate can predict patient outcome after Achilles tendon rupture. BMJ Open Sport Exerc Med. 2016 Jun 10;2(1):e000114. doi: 10.1136/bmjsem-2016-000114. eCollection 2016.