Non-operative Treatment of Acute Achilles Tendon Rupture: Early Controlled Mobilization Compared With Immobilization

NCT02015364 | Completed

• 1 other identifier: ATR_Denmark_2014
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

Study objectives To investigate if early controlled mobilization of the ankle in week 3 to 8 affects the functional outcome and patient reported outcome after treatment of acute Achilles tendon rupture. Type of study Randomized, controlled trial (RCT). 130 patients will be included. Time schedule Begins January 2014. Study period is 4-5 years; recruitment is expected to span 2 years Setup At Copenhagen University Hospital Hvidovre the majority of patients with acute ATR are treated non-operatively. A cast is applied in the emergency room. After 2 weeks the bandage is changed to a removable orthosis and full weight bearing is allowed. Patients who choose to participate in the trial will - through randomisation - be placed in one of the two groups:

1. 1.The intervention group: Must perform controlled mobilization-exercises from the beginning of week 3.
2. 2.The control group: In line with the current treatment regimen the patients must keep the boot on at all times and they are not allowed to move the ankle.

Conditions

Achilles Tendon Rupture; Deep Vein Thrombosis

Keywords

Achilles tendon; Rupture; Rehabilitation; Dynamic rehabilitation

Outcome Measures

Primary Outcomes (1)

• Achilles tendon Total Rupture Score

  A patient reported validation score developed to assess symptoms and physical activity after treatment for Achilles tendon rupture.

  12 months

Secondary Outcomes (25)

• Achilles tendon Total Rupture Score

  6 months

• Achilles tendon Total Rupture Score

  24 months

• Heel-rise work test

  6 months

• Heel-rise work test

  12 months

• Single heel-rise test

  6 months

Other Outcomes (1)

• DVT screening

  2 and 8 weeks

Study Arms (2)

Controlled early mobilization

EXPERIMENTAL

The intervention group: Must perform controlled mobilization-exercises from the beginning of week 3 to 8

Procedure: Controlled early mobilization

Immobilization

NO INTERVENTION

The control group: In line with the current treatment regimen the patients must keep the boot on at all times and they are not allowed to move the ankle.

Interventions

Controlled early mobilization PROCEDURE

1\. The intervention group: Must perform controlled mobilization-exercises from the beginning of week 3 - 8.

Controlled early mobilization

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• rupture happened within 5 days.
• Age 18-70 years.
• The patient must be expected to be able to attend rehabilitation and post-examinations.
• The patient must be able to speak and understand Danish.
• The patient must be able to give informed consent.

You may not qualify if:

• Former rupture of one or both Achilles tendon(s).
• Previous surgery on the Achilles tendon.
• Fluoroquinolone treatment within the last 6 months.
• Tendinosis treated with corticosteroids (tablets or injections) within the last 6 months.
• The patient has been diagnosed with arterial insufficiency in the legs.
• Terminal illness or severe medical illness: ASA score higher than or equal to 3.
• The space between the rupture and the calcaneus is less than 1cm.

Sponsors & Collaborators

• Hvidovre University Hospital: lead
• DJO Incorporated: collaborator
• The Danish Rheumatism Association: collaborator

Study Sites (1)

Copenhagen University Hospital Hvidovre

Hvidovre, Copenhagen, 2650, Denmark

Location

Related Publications (3)

• Barfod KW, Nielsen EG, Olsen BH, Vinicoff PG, Troelsen A, Holmich P. Risk of Deep Vein Thrombosis After Acute Achilles Tendon Rupture: A Secondary Analysis of a Randomized Controlled Trial Comparing Early Controlled Motion of the Ankle Versus Immobilization. Orthop J Sports Med. 2020 Apr 28;8(4):2325967120915909. doi: 10.1177/2325967120915909. eCollection 2020 Apr.

  PMID: 32426409 DERIVED

• Barfod KW, Hansen MS, Holmich P, Kristensen MT, Troelsen A. Efficacy of early controlled motion of the ankle compared with immobilisation in non-operative treatment of patients with an acute Achilles tendon rupture: an assessor-blinded, randomised controlled trial. Br J Sports Med. 2020 Jun;54(12):719-724. doi: 10.1136/bjsports-2019-100709. Epub 2019 Oct 9.

  PMID: 31597624 DERIVED

• Barfod KW, Hansen MS, Holmich P, Troelsen A, Kristensen MT. Efficacy of early controlled motion of the ankle compared with no motion after non-operative treatment of an acute Achilles tendon rupture: study protocol for a randomized controlled trial. Trials. 2016 Nov 29;17(1):564. doi: 10.1186/s13063-016-1697-2.

  PMID: 27894329 DERIVED

MeSH Terms

Conditions

Venous Thrombosis; Rupture

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries

Study Officials

• Kristoffer W Barfod, MD

  Copenhagen University Hospital, Hvidovre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 13, 2013
• First Posted: December 19, 2013
• Study Start: February 1, 2014
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: August 13, 2019

Record last verified: 2019-08

Locations

DK (1)