Trial Outcomes & Findings for Compression Treatment Effects on Complications and Healing of Achilles Tendon Rupture (NCT NCT01317160)

NCT ID: NCT01317160

Last Updated: 2024-03-07

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 150 participants
• Primary outcome timeframe: 2 weeks
• Results posted on: 2024-03-07

Participant Flow

Participant milestones

Measure	Routine Care: Plaster Cast Treatment Two weeks of postoperative conventional lower limb plaster cast immobilization in 30 degrees of plantarflexion	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.
Overall Study STARTED	75	75
Overall Study Allocation to Treatment	74	74
Overall Study COMPLETED	71	69
Overall Study NOT COMPLETED	4	6

Reasons for withdrawal

Measure	Routine Care: Plaster Cast Treatment Two weeks of postoperative conventional lower limb plaster cast immobilization in 30 degrees of plantarflexion	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.
Overall Study Incorrect inclusion	1	1
Overall Study Lost to Follow-up	3	3
Overall Study Withdrawal by Subject	0	2

Baseline Characteristics

Compression Treatment Effects on Complications and Healing of Achilles Tendon Rupture

Baseline characteristics by cohort

Measure	Routine Care: Plaster Cast Treatment n=71 Participants Two weeks of postoperative conventional lower limb plaster cast immobilization in 30 degrees of plantarflexion	Intermittent Pneumatic Compression (IPC) n=69 Participants 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.	Total n=140 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	70 Participants n=5 Participants	69 Participants n=7 Participants	139 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	39.9 years n=5 Participants	40.9 years n=7 Participants	40.4 years n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	8 Participants n=7 Participants	21 Participants n=5 Participants
Sex: Female, Male Male	58 Participants n=5 Participants	61 Participants n=7 Participants	119 Participants n=5 Participants
Region of Enrollment Sweden	71 participants n=5 Participants	69 participants n=7 Participants	140 participants n=5 Participants
Tobacco user Tobacco user: Yes	8 participants n=5 Participants	5 participants n=7 Participants	13 participants n=5 Participants
Tobacco user Tobacco user: No	63 participants n=5 Participants	64 participants n=7 Participants	127 participants n=5 Participants
Body mass index	26.7 Kg/m/m n=5 Participants	27.1 Kg/m/m n=7 Participants	26.9 Kg/m/m n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks

Population: 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.

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.

Outcome measures

Measure	Routine Care: Plaster Cast Treatment n=71 Participants Two weeks of postoperative conventional lower limb plaster cast immobilization in 30 degrees of plantarflexion	Intermittent Pneumatic Compression (IPC) n=67 Participants 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.
Venous Thromboembolic Events (VTE)	26 participants	14 participants

SECONDARY outcome

Timeframe: one year

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.

Outcome measures

Measure	Routine Care: Plaster Cast Treatment n=70 Participants Two weeks of postoperative conventional lower limb plaster cast immobilization in 30 degrees of plantarflexion	Intermittent Pneumatic Compression (IPC) n=56 Participants 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.
Functional Outcome - Muscular Endurance Tests (Heel-rise) LSI of average height of heel-rise	78.5 Index of Injured versus uninjured side Standard Deviation 14.6	82.5 Index of Injured versus uninjured side Standard Deviation 17.0
Functional Outcome - Muscular Endurance Tests (Heel-rise) LSI of Eccentric power (W)	78.2 Index of Injured versus uninjured side Standard Deviation 15.8	82.6 Index of Injured versus uninjured side Standard Deviation 22.9
Functional Outcome - Muscular Endurance Tests (Heel-rise) LSI of Heel-rise repetitions	83.0 Index of Injured versus uninjured side Standard Deviation 22.5	84.1 Index of Injured versus uninjured side Standard Deviation 19.1
Functional Outcome - Muscular Endurance Tests (Heel-rise) LSI of total concentric work (J)	66.8 Index of Injured versus uninjured side Standard Deviation 22.2	69.4 Index of Injured versus uninjured side Standard Deviation 20.1
Functional Outcome - Muscular Endurance Tests (Heel-rise) LSI of concentric power (W)	81.3 Index of Injured versus uninjured side Standard Deviation 24.3	74.2 Index of Injured versus uninjured side Standard Deviation 32.3

SECONDARY outcome

Timeframe: 6 weeks

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.

Outcome measures

Measure	Routine Care: Plaster Cast Treatment n=71 Participants Two weeks of postoperative conventional lower limb plaster cast immobilization in 30 degrees of plantarflexion	Intermittent Pneumatic Compression (IPC) n=69 Participants 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.
Venous Thromboembolic Events (VTE)	34 participants	36 participants

SECONDARY outcome

Timeframe: One year

Population: Achilles tendon Total Rupture Score (0-100, 100=best outcome) is presented here.

The patients' symptoms will be assessed using the Achilles tendon Total Rupture Score (0-100, 100=best)

Outcome measures

Measure	Routine Care: Plaster Cast Treatment n=64 Participants Two weeks of postoperative conventional lower limb plaster cast immobilization in 30 degrees of plantarflexion	Intermittent Pneumatic Compression (IPC) n=55 Participants 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.
Patient-reported Outcome	78 score on a scale Standard Deviation 19.3	77.8 score on a scale Standard Deviation 17.2

SECONDARY outcome

Timeframe: 2 weeks

Population: Concentration of procollagen type I (PINP) ng/ml.

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.

Outcome measures

Measure	Routine Care: Plaster Cast Treatment n=19 Participants Two weeks of postoperative conventional lower limb plaster cast immobilization in 30 degrees of plantarflexion	Intermittent Pneumatic Compression (IPC) n=14 Participants 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.
Microdialysis	2.05 ng/mL Standard Deviation 0.78	3.47 ng/mL Standard Deviation 1.81

SECONDARY outcome

Timeframe: 1 year

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.

Outcome measures

Measure	Routine Care: Plaster Cast Treatment n=70 Participants Two weeks of postoperative conventional lower limb plaster cast immobilization in 30 degrees of plantarflexion	Intermittent Pneumatic Compression (IPC) n=69 Participants 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.
Time From Injury to Surgery	62.33 hours Standard Deviation 24.45	62.18 hours Standard Deviation 26.19

OTHER_PRE_SPECIFIED outcome

Timeframe: Surgery will be performed within 10 days of injury

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Surgery will be performed within 10 days of injury

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.

Outcome measures

Outcome data not reported

Adverse Events

Routine Care: Plaster Cast Treatment

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Intermittent Pneumatic Compression (IPC)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Routine Care: Plaster Cast Treatment n=71 participants at risk Two weeks of postoperative conventional lower limb plaster cast immobilization in 30 degrees of plantarflexion	Intermittent Pneumatic Compression (IPC) n=69 participants at risk；n=71 participants at risk 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.
Infections and infestations Infections	5.6% 4/71 • Number of events 4 • 6 weeks At outpatients visit	2.9% 2/69 • Number of events 2 • 6 weeks At outpatients visit
Surgical and medical procedures Re-rupture	1.4% 1/71 • Number of events 1 • 6 weeks At outpatients visit	1.4% 1/69 • Number of events 1 • 6 weeks At outpatients visit

Additional Information

Dr. Paul W. Ackermann

Karolinska university Hospital

Phone: +46851770000

Email: paul.ackermann@karolinska.se

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place