RuptureNCT01317160
Compression Treatment Effects on Complications and Healing of Achilles Tendon Rupture
A study testing Intermittent pneumatic compression (IPC) in people with Rupture and Venous Thromboembolism, run by Karolinska University Hospital at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rupture, Venous Thromboembolism, Venous Thrombosis
- What is being tested?
- Intermittent pneumatic compression (IPC)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2011to Sep 2018
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Achilles tendon rupture operated on within 96 hours of diagnose.
Who cannot join
- 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
Show all 11Show fewer
- Recent thromboembolic event (during the preceding 3 months)
- Recent surgery (during the preceding month)
- Presence of known malignancy
- Current bleeding disorder
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intermittent Pneumatic Compression Effects on Venous Thromboembolism Incidence and Healing of Achilles Tendon Rupture
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.
Read more
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.
- 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.
Read the 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.
- Being tested
- Intermittent pneumatic compression (IPC)
- Keywords
- Achilles Tendon, Immobilization, Wound Healing, Intermittent Pneumatic Compression, Ultrasonography, Microdialysis
- Medical subject headings
- Rupture, Venous Thromboembolism, Venous Thrombosis, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent pneumatic compression (IPC)Device
Also called VenaFlow Elite system, VenaFlow® 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.
| Study group | Role | What they receive |
|---|---|---|
| Routine care: Plaster Cast Treatment | No intervention | Two weeks of postoperative conventional lower limb plaster cast immobilization in 30 degrees of plantarflexion |
| Intermittent pneumatic compression (IPC) | Experimental | Two weeks of calf IPC by Aircast® VenaFlow® Elite System during immobilization in an orthosis Aicast® XP Walker. Receives: Device: Intermittent pneumatic compression (IPC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Venous Thromboembolic Events (VTE)
At 2 weeks postoperatively the number of participants with VTE events will be assessed by:
- DVT detected by compression duplex ultrasound (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.
Measured: 2 weeks
Secondary outcomes (5)
Functional Outcome - Muscular Endurance Tests (Heel-rise)
The functional outcome was assessed at 1year post-operatively by the validated calf muscle endurance test, i.e. heel rise test (Silbernagel KG et al. A new measurement of heel-rise endurance with the ability to detect functional deficits in patients with Achilles tendon rupture. Knee Surg Sports Traumatol Arthrosc. 2010). The Muscle lab linear encoder (Ergotest Technology, Oslo, Norway), was used for data collection. Standardized footwear was used. Patients warmed up before testing. During the heel-rise test, verbal encouragement was used. The patient was instructed to go as high as possible on each heel-rise with a straight knee. A metronome was used for standardized frequency of 30 heel-rises per minute. The test was terminated when the patient stopped or could not maintain frequency. For analysis, the limb symmetry index (LSI, percentage of injured vs. uninjured side) values were used.
Measured: one year
Venous Thromboembolic Events (VTE)
At 6 weeks postoperatively the number of participants with VTE events will be assessed by:
- DVT detected by compression duplex ultrasound (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.
Measured: 6 weeks
Patient-reported Outcome
The patients' symptoms will be assessed using the Achilles tendon Total Rupture Score (0-100, 100=best)
Measured: One year
Microdialysis
At 2 weeks postoperatively in-vivo microdialysis will be performed on as described by Greve et al 2012 (DOI: 10.1111/j.1600-0838.2012.01475.x).
In the microdialysate substances will be assessed, eg. markers of tendon callus production, procollagen type I (PINP), by enzymatic quantification.
Measured: 2 weeks
Time From Injury to Surgery
Prognostic factor:
Time to surgery , i.e. the time from ATR injury to start of the surgical procedure, will be calculated by using the time-point at which the patient sustained the injury as described in the patient journal, as well as the starting time point of the surgery as registered in the computerized operation report.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionAug 2015
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for RuptureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm, DJO Incorporated
- Responsible party
- Principal investigator, Paul Ackermann, Karolinska University Hospital
- Investigators
- Paul W Ackermann, MD, PhD, Principal investigator, Karolinska University Hospital, 171 76 Stockholm, SWEDEN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01317160
- Sponsor's protocol ID
- IPC-Achilles
- Other IDs
- SLL20100168
- Status last verified
- Mar 2024
- First submitted
- 16 Mar 2011
- Last updated
- 7 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Plan to share data on primary outcome (DVT)
Publications
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.
PubMed 25922463Abdul 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.
PubMed 28668970Chen J, Wang J, Hart DA, Zhou Z, Ackermann PW, Ahmed AS. Complement factor D regulates collagen type I expression and fibroblast migration to enhance human tendon repair and healing outcomes. Front Immunol. 2023 Sep 6;14:1225957. doi: 10.3389/fimmu.2023.1225957. eCollection 2023.
PubMed 37744351Wu X, Chen J, Sun W, Hart DA, Ackermann PW, Ahmed AS. Network proteomic analysis identifies inter-alpha-trypsin inhibitor heavy chain 4 during early human Achilles tendon healing as a prognostic biomarker of good long-term outcomes. Front Immunol. 2023 Jul 6;14:1191536. doi: 10.3389/fimmu.2023.1191536. eCollection 2023.
PubMed 37483617Chen J, Wang J, Wu X, Simon N, Svensson CI, Yuan J, Hart DA, Ahmed AS, Ackermann PW. eEF2 improves dense connective tissue repair and healing outcome by regulating cellular death, autophagy, apoptosis, proliferation and migration. Cell Mol Life Sci. 2023 Apr 21;80(5):128. doi: 10.1007/s00018-023-04776-x.
PubMed 37084140Chen 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.
PubMed 35596679Svedman 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.
PubMed 30169112Alim 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.
PubMed 27900179