Development of Achilles Tendon Elongation and Its Effect on Physical Function the First Year After Rupture

NCT03525314 | Completed DMC

• 1 other identifier: Achilles HVH Cohort
• Study Type: observational
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to examine how elongation of the Achilles tendon develops during the first year after rupture among patients with an Achilles tendon rupture, and how it affects physical function. The aim is to define a cutoff of acceptable elongation dividing the patients who obtain normal physical function (Limb Symmetry Index \> 90%) from those who do not. Patients treated both operatively and non-operatively will be included.

Conditions

Achilles Tendon Rupture

Outcome Measures

Primary Outcomes (1)

• Copenhagen Achilles Length Measure

  The examination of both the total and the free part of the achilles tendon of both the injured and un-injured leg is performed. The free part of the achilles tendon is defined as the distance between the proximal border of calcaneus and the musculotendinous junction of the soleus muscle. The total length of the achilles tendon is the distance between the proximal border of calcaneus and the musculotendinous junction of the medial gastrocnemius muscle. Measurement is perfomed as described by Barfod et al (1).

  Evaluation method after 12 months of started treatment

Secondary Outcomes (6)

• Copenhagen Achilles Length Measure

  Evaluation method after 0-4 days, 3 weeks, 9 weeks, 4 months, 6 months of started treatment

• Indirectly, clinical Achilles tendon length estimate

  Evaluation method after 9 weeks, 4, 6 and 12 months of started treatment.

• Achilles tendon Total Rupture Score (ATRS)

  Evaluation method after 0-4 days, 3 weeks, 9 weeks, 4, 6 and 12 months of started treatment

• Heel-rise Work test

  Evaluation method after 4, 6 and 12 months of started treatment.

• Calf circumference

  Evaluation method after 9 weeks, 4, 6 and 12 months of started treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients treated for acute Achilles tendon rupture at Amager-Hvidovre Hospital during the study period will be offered to participate in the study. The study cohort of study with uniqe clinical trials ID: Achilles HVH RCT is also included in this cohort.

You may qualify if:

• Appointment in the Outpatients Department within 4 days of injury.
• Total Achilles tendon rupture.
• Initial treatment with split cast with the ankle in maximal plantar flexion must be started within 24 hours of injury.
• The patient must be expected to be able to attend rehabilitation and postexaminations.
• The patient must be able to speak and understand Danish.
• The patient must be able to give informed consent.

You may not qualify if:

• Rupture of the Achilles tendon either at the insertion on the calcaneus or at musculotendinous junction of the triceps surae.
• Previous rupture of the Achilles tendon in any of the two legs.
• Treated with Fluorquinolons or corticosteroids within the last 6 months.
• In medical treatment of diabetes.
• Suffers from rheumatic disease.
• Other conditions prior to the injury resulting in reduced function of any of the two legs.
• Contra-indication for surgery: severe arthrosclerosis with no palpable pulse in the foot, broken skin in the Achilles region of the injured leg.
• Inability to lie in prone position on the operating table.
• Terminal illness or severe medical illness: ASA (American Society of Anesthesiologists) score higher than or equal to 3.

Sponsors & Collaborators

• Hvidovre University Hospital: lead

Study Sites (1)

Department of Physiotherapy and Orthopedical surgery, Copenhagen University Hospital, Amager-Hvidovre

Copenhagen, Hvidovre, DK-2650, Denmark

Location

Related Publications (1)

• Barfod KW, Riecke AF, Boesen A, Hansen P, Maier JF, Dossing S, Troelsen A. Validation of a novel ultrasound measurement of achilles tendon length. Knee Surg Sports Traumatol Arthrosc. 2015 Nov;23(11):3398-406. doi: 10.1007/s00167-014-3175-2. Epub 2014 Jul 20.

  PMID: 25038882 BACKGROUND

Study Officials

• Maria S Hansen, PT, MSc

  Copenhagen University Hospital, Amager-Hvidovre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 3, 2018
• First Posted: May 15, 2018
• Study Start: June 6, 2018
• Primary Completion: December 10, 2020
• Study Completion: December 10, 2020
• Last Updated: March 16, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)