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| ID | Type | Description | Link |
|---|---|---|---|
| SLL20100168 | Other Grant/Funding Number | ALF - Stockholm County Council and Karolinska Institutet |
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| Name | Class |
|---|---|
| Region Stockholm | OTHER_GOV |
| DJO Incorporated | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intermittent pneumatic compression (IPC) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Venous Thromboembolic Events (VTE) | At 2 weeks postoperatively the number of participants with VTE events will be assessed by: 1) 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. | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Surgeon Sex | Prognostic factor: All patients are operated on according to a standardized surgical protocol. and the surgeon on duty will perform the surgical repair and no specific surgeon can be selected by the patients. Unknown sex of the operating surgeon will be included as an additional exclusion criterion in the study. | Surgery will be performed within 10 days of injury |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul W Ackermann, MD, PhD | Karolinska University Hospital, 171 76 Stockholm, SWEDEN | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska University Hospital | Stockholm | 17176 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25922463 | Result | 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. | |
| 28668970 |
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Plan to share data on primary outcome (DVT)
Starting 12 months after publication the data will be available for 10 years after the study is published.
Contact PI.
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| ID | Title | Description |
|---|---|---|
| FG000 | Routine Care: Plaster Cast Treatment | Two weeks of postoperative conventional lower limb plaster cast immobilization in 30 degrees of plantarflexion |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Routine Care: Plaster Cast Treatment | Two weeks of postoperative conventional lower limb plaster cast immobilization in 30 degrees of plantarflexion |
| BG001 | Intermittent Pneumatic Compression (IPC) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Venous Thromboembolic Events (VTE) | At 2 weeks postoperatively the number of participants with VTE events will be assessed by: 1) 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. | Non-compliance was defined by exposure to less than ten hours of IPC. Therefore, two patients were withdrawn on this basis and the treatment group comprised 67 patients at final analysis. | Posted | Number | participants | 2 weeks |
|
6 weeks
At outpatients visit
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Routine Care: Plaster Cast Treatment | Two weeks of postoperative conventional lower limb plaster cast immobilization in 30 degrees of plantarflexion |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infections | Infections and infestations | Systematic Assessment | Local infections |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Paul W. Ackermann | Karolinska university Hospital | +46851770000 | paul.ackermann@karolinska.se |
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| ID | Term |
|---|---|
| D012421 | Rupture |
| D054556 | Venous Thromboembolism |
| D020246 | Venous Thrombosis |
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D048228 | Intermittent Pneumatic Compression Devices |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
Not provided
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|
|
| one year |
| Venous Thromboembolic Events (VTE) | At 6 weeks postoperatively the number of participants with VTE events will be assessed by: 1) 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. | 6 weeks |
| Patient-reported Outcome | The patients' symptoms will be assessed using the Achilles tendon Total Rupture Score (0-100, 100=best) | 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. | 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. | 1 year |
| Surgeon Experience | Prognostic factor: All patients are operated on according to a standardized surgical protocol. and the surgeon on duty will perform the surgical repair and no specific surgeon can be selected by the patients. The experienced group of surgeons will consist of specialists accredited with a specialist licence issued by The Swedish National Board of Health and Welfare. The less experienced group of surgeons will consist of residents. | Surgery will be performed within 10 days of injury |
| 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. |
| 37744351 | Derived | Chen 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. |
| 37483617 | Derived | Wu 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. |
| 37084140 | Derived | Chen 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. |
| 35596679 | Derived | 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. |
| 30169112 | Derived | 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. |
| 27900179 | Derived | 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. |
| Withdrawal by Subject |
|
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.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Tobacco user | Number | participants |
|
| Body mass index | Mean | Full Range | Kg/m/m |
|
| 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. |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Index of Injured versus uninjured side | one year |
|
|
|
| Secondary | Venous Thromboembolic Events (VTE) | At 6 weeks postoperatively the number of participants with VTE events will be assessed by: 1) 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. | Posted | Number | participants | 6 weeks |
|
|
|
|
| Secondary | Patient-reported Outcome | The patients' symptoms will be assessed using the Achilles tendon Total Rupture Score (0-100, 100=best) | Achilles tendon Total Rupture Score (0-100, 100=best outcome) is presented here. | Posted | Mean | Standard Deviation | score on a scale | One year |
|
|
|
| Secondary | 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. | Concentration of procollagen type I (PINP) ng/ml. | Posted | Mean | Standard Deviation | ng/mL | 2 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | hours | 1 year |
|
|
|
| Other Pre-specified | Surgeon Sex | Prognostic factor: All patients are operated on according to a standardized surgical protocol. and the surgeon on duty will perform the surgical repair and no specific surgeon can be selected by the patients. Unknown sex of the operating surgeon will be included as an additional exclusion criterion in the study. | Not Posted | Aug 2024 | Surgery will be performed within 10 days of injury | Participants |
| Other Pre-specified | Surgeon Experience | Prognostic factor: All patients are operated on according to a standardized surgical protocol. and the surgeon on duty will perform the surgical repair and no specific surgeon can be selected by the patients. The experienced group of surgeons will consist of specialists accredited with a specialist licence issued by The Swedish National Board of Health and Welfare. The less experienced group of surgeons will consist of residents. | Not Posted | Surgery will be performed within 10 days of injury | Participants |
| 0 |
| 71 |
| 5 |
| 71 |
| EG001 | 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. | 0 | 71 | 3 | 69 |
| Re-rupture | Surgical and medical procedures | Systematic Assessment | Re-rupture of the Achilles tendon occurring before the 6 weeks follow up |
|
Not provided
Not provided
| D002318 |
| Cardiovascular Diseases |
| D013927 | Thrombosis |
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| LSI of Heel-rise repetitions |
|
| LSI of total concentric work (J) |
|
| LSI of concentric power (W) |
|