EarlyM-Achil: Early Mobilization After Achilles Tendon Rupture

Sponsor

Karolinska University Hospital (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02318472

Collaborator

OPED GmbH (Other)

150

Enrollment

Location

Arms

111.9

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Achilles Tendon Rupture Deep Venous Thrombosis	Device: VACOped orthosis Device: Plaster cast	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 1, 2013

Actual Primary Completion Date :

Mar 1, 2019

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Early mobilization Functional mobilization initiated directly post-operative with a weight-bearing VACOped orthosis with adjustable range of motion of the ankle	Device: VACOped orthosis Weight-bearing orthosis with adjustable range of motion of the ankle
Active Comparator: Immobilization Treatment as usual using plaster cast immobilization	Device: Plaster cast Lower limb plaster cast

Arm

Intervention/Treatment

Experimental: Early mobilization

Functional mobilization initiated directly post-operative with a weight-bearing VACOped orthosis with adjustable range of motion of the ankle

Device: VACOped orthosis

Weight-bearing orthosis with adjustable range of motion of the ankle

Active Comparator: Immobilization

Treatment as usual using plaster cast immobilization

Device: Plaster cast

Lower limb plaster cast

Outcome Measures

Primary Outcome Measures

Deep venous thrombosis (DVT) [Six weeks]
At 2 and 6 weeks postoperatively the number of participants with DVT will be assessed by compression duplex ultrasound (CDU)

Secondary Outcome Measures

Functional outcome - muscular endurance tests (heel-rise) [Four years]
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.
Patient-reported outcome - ATRS [Four years]
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
Patient-reported outcome - EQ-5D [One year]
The patients' symptoms will be assessed using the reliable and valid score; EuroQol Group's questionnaire (EQ-5D).
Physical activity - PAS [Four years]
The patients' physical activity levels will be assessed a valid score; the Physical Activity scale (PAS). 6, 12 months and 3-4 years postoperatively
Patient-reported outcome - The Foot and Ankle Outcome Score (FAOS) [One year]
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
Patient-reported outcome - RAND 36 Health and Quality of Life questionnaire [One year]
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
Patient-reported outcome - Tampa Scale of Kinesiophobia, Swedish version, TSK-SV [One year]
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
Plantar force loading [Six weeks]
Measured with mobile force sensors, insoles at 2 and 6 weeks postoperatively
Patient-reported diary - self-reported loading [Two weeks]
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.
Patient-reported diary - pain ratings [Two weeks]
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.
Patient-reported diary - steps/day [Two weeks]
Measurement of number of steps taken each day with a valid pedometer at home during the first 2 weeks postoperatively
Calf circumference [Four years]
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
Ankle dorsiflexion [Six weeks]
Ankle range of motion in dorsiflexion, measured in sitting position with goniometer at 2 and 6 weeks postoperatively
Tendon length measurement [Four years]
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
Tendon thickness measurement [One year]
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
Muscle volume of the calf muscles [One year]
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
Thickness of the calf muscles [One year]
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
Achilles Tendon resting angle (ATRA) [Four years]
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
3D gait analysis [6 months]
Three-dimensional gait analysis, performed at 8 weeks and 6 months postoperatively, measurement of the quality of gait

Other Outcome Measures

Tendon healing using microdialysis [Two weeks]
Microdialysis will be followed by quantification of markers for tendon repair
Time to surgery [Within 10 days]
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.
Surgeon sex [Surgery is performed within 10 days after 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.
Surgeon experience [Surgery is performed within 10 days after 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.