Early Mobilization After Achilles Tendon Rupture

Deep Venous Thrombosis Clinical Trial

— EarlyM-Achil  

Official title:

Effects of Direct Functional Mobilization After Achilles Tendon Rupture on Healing and Outcome

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02318472
• Other study ID #: VR2012-2510
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 2013
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether early mobilization after Achilles tendon rupture can speed up healing, prevent development of venous thromboembolism and improve patient outcome.

Description:

Patients with acute Achilles tendon rupture will be screened for eligibility at the Karolinska University Hospital and Södersjukhuset, Stockholm.

One hundred-fifty patients will be included and enrolled and assigned to the interventions either by a third party nurse or by a research nurse. Randomisation will be performed with use of computer-generated random numbers in permuted blocks of four, through an independent software specialist, and consecutively numbered, sealed, opaque envelopes opened after surgery and prior to treatment.

The patients will be randomized to undergo either treatment as usual using plaster cast treatment alone or direct post-operative functional mobilization with a weight-bearing orthosis with adjustable range of motion of the ankle.

The power calculation was based upon data from a recent study reporting a 50% rate of CDU-verified DVT after ATR surgery (Domeij-Arverud et a. 2015). We estimated early functional mobilization (EFM) to confer a 50% risk reduction. Sixty-three patients in each group were required to detect a difference of 25% in the incidence of DVT (two-sided type-I error rate = 5%; power = 80%). We decided to include 150 patients to counteract drop-outs. On recommendations from the ethical committee, a ratio of 2:1 was chosen, since our hypothesis was that the EFM group would perform better.

The endpoint of the first part of the study is tendon healing quantified at 2 weeks by microdialysis followed by quantification of markers for tendon repair. The sample size for the outcome in the microdialysis study was calculated on a difference of the glutamate metabolite of 12 µM between the two groups. For this power analysis, we used a glutamate standard difference of 15 µM resulting from a previous study. It was determined that a sample size of 25 patients per group would be necessary to detect the glutamate difference with 80% power when alpha was set equal to 5%. Anticipating that we would lose 10% of participants enrolled, we plan to enroll 27 patients in each group for microdialysis.

The primary aim of the short-term follow up of this randomized, controlled trial was to assess the efficacy of EFM to reduce the DVT incidence after ATR surgery, at two and six weeks post-operatively, compared to treatment-as-usual, i.e. two weeks of plaster cast followed by four weeks' orthosis immobilization. The secondary aim was to evaluate the effect of patient intrinsic factors (age, BMI, calf circumference, ankle range of motion, pain and fear of movement) and patient extrinsic factors (amount of weightbearing, number of daily steps) on the risk of sustaining a DVT.

The primary aim with the long-term follow up is to investigate the effect of early postoperative functional mobilization compared to immobilization on patient-reported function, health, fear of movement, physical activity level, and differences in functional capacity. The second aim is to explore if the occurrence of DVT postoperatively effects functional outcome in the long-term after surgical treatment of ATR.

Additional aims:

The primary aim of the second part of this study was to assess the number of steps and the amount of loading in a weight bearing orthosis during the first six weeks post-surgical ATR repair. A secondary purpose was to investigate if the amount of loading was correlated to fear of movement or/and pain.

The aim with this substudy is to describe differences between the two groups over time regarding tendon elongation, differences in muscle cross-sectional area and differences in tendon cross-sectional area (on the injured side) and to examine if the differences can predict functional outcome in the long-term and if any of the follow-up occasions are most important for long-term functional outcome.

Few studies have evaluated outcome more than one year after injury. The aim of this substudy is to investigate differences in outcome at 3 years after injury between the patients that sustained a DVT and those who did not sustain a DVT. Another aim is to compare the two intervention groups over 3-years time.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: December 2024
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Acute unilateral ATR, operated on within 96 hours

• Age between 18 and 75 years

Exclusion Criteria:

• Inability to give informed consent

• Current anticoagulation treatment (including high dose acetylsalicylic acid)

• Planned follow-up at other hospital

• Inability to follow instructions

• Known kidney failure

• Heart failure with pitting oedema

• Thrombophlebitis

• Thromboembolic event during the previous three months

• Other surgery during the previous month

• Known malignancy

• Haemophilia; and pregnancy

Related Conditions & MeSH terms

• Achilles Tendon Rupture
• Deep Venous Thrombosis
• Rupture
• Thrombosis
• Venous Thrombosis

Intervention

Device:
• VACOped orthosis
Weight-bearing orthosis with adjustable range of motion of the ankle
• Plaster cast
Lower limb plaster cast

Locations

Country	Name	City	State
Sweden	Karolinska university Hospital	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska University Hospital	OPED GmbH

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Tendon healing using microdialysis	Microdialysis will be followed by quantification of markers for tendon repair	Two weeks
Other	Time 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.	Within 10 days
Other	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 is performed within 10 days after injury
Other	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 is performed within 10 days after injury
Primary	Deep venous thrombosis (DVT)	At 2 and 6 weeks postoperatively the number of participants with DVT will be assessed by compression duplex ultrasound (CDU)	Six weeks
Secondary	Functional outcome - muscular endurance tests (heel-rise)	The functional outcome will be assessed at 26 and 52 weeks and 3-4 years postoperatively by validated muscular endurance test, i.e. heel rise test.	Four years
Secondary	Patient-reported outcome - ATRS	The patients' symptoms will be assessed using the reliable and valid score; the Achilles tendon Total Rupture Score (ATRS). 6, 12 months and 3-4 years postoperatively	Four years
Secondary	Patient-reported outcome - EQ-5D	The patients' symptoms will be assessed using the reliable and valid score; EuroQol Group's questionnaire (EQ-5D).	One year
Secondary	Physical activity - PAS	The patients' physical activity levels will be assessed a valid score; the Physical Activity scale (PAS). 6, 12 months and 3-4 years postoperatively	Four years
Secondary	Patient-reported outcome - The Foot and Ankle Outcome Score (FAOS)	The patients' symptoms will be assessed using the reliable and valid score; The Foot and Ankle Outcome Score. FAOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Functioning sport and recreation (Sport(Rec), and foot and ankle-related Quality of Life (QOL). Each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. Assessed 6 and 12 months postoperatively	One year
Secondary	Patient-reported outcome - RAND 36 Health and Quality of Life questionnaire	The patients' symptoms will be assessed using the reliable and valid score; The RAND-36 Health and Quality of Life. The questionnaire is composed of 36 items, scored from 1 to 2,3, 5 or 6, some items are scored reversed. The score is divided in 8 subscales (dimensions) as the SF-36 questionnarie. The software recodes the points to a scale of 0 (worst) to 100 (best) for each subscale. Assessed at 6 and 12 months postoperatively	One year
Secondary	Patient-reported outcome - Tampa Scale of Kinesiophobia, Swedish version, TSK-SV	The patients' symptoms will be assessed using the reliable and valid score; The Tampa Scale of Kinesiophobia-SV. The scale comprises of 17 items and a total score is computed. 4 items are inverted and rescaled Before summation. Each item are scored from 1 (strongly disagree) to 4 (strongly agree). The total sum is between 17 to 68, where a score of more than 37 is defined as kinesiophobia. Assessed at 2 and 6 weeks and 6 and 12 months postoperatively	One year
Secondary	Plantar force loading	Measured with mobile force sensors, insoles at 2 and 6 weeks postoperatively	Six weeks
Secondary	Patient-reported diary - self-reported loading	Estimation on daily self-reported loading on a VAS-scale, scored from 0 (non-weightbearing) to 100 (full weightbearing). Performed at home during the first 2 weeks postoperatively. The VAS scale is converted to percent (%) for analysis.	Two weeks
Secondary	Patient-reported diary - pain ratings	Pain ratings on a VAS-scale at home during the first week postoperatively. The patients are rating their pain from 0 (no pain) to 100 (worst imaginable pain) during activity and at rest.	Two weeks
Secondary	Patient-reported diary - steps/day	Measurement of number of steps taken each day with a valid pedometer at home during the first 2 weeks postoperatively	Two weeks
Secondary	Calf circumference	Measured with a tape measure at the thickest part of the calf in sitting position at 2 and 6 weeks and 6, 12 months and 3-4 years postoperatively	Four years
Secondary	Ankle dorsiflexion	Ankle range of motion in dorsiflexion, measured in sitting position with goniometer at 2 and 6 weeks postoperatively	Six weeks
Secondary	Tendon length measurement	Ultrasound measurement on Achilles tendon length, measured in centimeters, from the calcaneal bone to the gastrocnemius and the soleus muscles, with extended field-of-view images. Images taken at 2 and 6 weeks and 6 and 12 months and 3-4 years postoperatively	Four years
Secondary	Tendon thickness measurement	Ultrasound measurement on Achilles tendon circumference (thickness), measured in cm2, with B-mode images. Images taken at 2 and 6 weeks and 6 and 12 months postoperatively	One year
Secondary	Muscle volume of the calf muscles	Ultrasound measurement on muscle volume of the calf muscles (gastrocnemius), measured in cm2, with extended field-of-view images. Images taken at 2 and 6 weeks and 6 and 12 months postoperatively	One year
Secondary	Thickness of the calf muscles	Ultrasound measurement on thickness of the calf muscle (soleus). Measured in centimeter, with B-mode images. Images taken at 2 and 6 weeks and 6 and 12 months postoperatively	One year
Secondary	Achilles Tendon resting angle (ATRA)	A clinical measurement of indirect Tendon length with patient prone lying, measured with goniometer with arms parallell to fibula and MTP5, measured at 2 and 6 weeks and 6 and 12 months and 3-4 years postoperatively	Four years
Secondary	3D gait analysis	Three-dimensional gait analysis, performed at 8 weeks and 6 months postoperatively, measurement of the quality of gait	6 months