Title

Correlation between the gap size of an acute Achilles tendon rupture on MRI and the clinical outcome

Last Updated: March 22/2017

The proposed study is a retrospective non-comparative cohort study including adult patients who are currently undergoing non-operative treatment using a standardized casting/bracing and physiotherapy protocol for acute complete ruptures of the Achilles tendon. Included patients must have undergone MRI assessment of their injured tendon early in the course of their treatment while in a plantarflexed cast. Initial MRI data will be retrospectively reviewed and correlation between the gap size of an acute Achilles tendon rupture on MRI  to the prospectively collected clinical outcome data at 1 year follow-up.

Level 3: Evidence from well-designed case-control and cohort studies

Eligibility

Inclusion Criteria: Patients presenting with a complete mid-substance rupture of the Achilles tendon as diagnosed on clinical exam (with a positive Thompson squeeze test and a palpable gap in the tendon substance) and confirmed by MRI imaging, who are willing and able to comply with and participate in the rehabilitation protocol, have presented in a timely manner to allow initiation of either treatment within 7 days of their injury, and provide informed consent are candidates for study participation.

Exclusion Criteria: Patients who were not placed in a NWB plantar flexed cast within 24 hours of Injury. Patients with an open Achilles injury, an Achilles injury that is not a mid-substance tendon injury (ie. an Achilles avulsion from the calcaneal insertion or a musculotendinous junction tear/rupture), any additional injury to the ipsilateral lower extremity, a prior rupture or other significant injury to the same Achilles tendon, any functional impairment (physical or mental) that may interfere with compliance with the rehabilitation protocol, any, known factor for increased risk of Achilles tendon rupture (i.e. diabetes mellitus, immunosuppressive therapy including local or systemic steroids, and fluoroquinolone use)

Sample Size calculation:

Using correlational analysis with a power set at 0.8 and α = 0.05 with an expected medium effect size, we would require 85 participants. A total of 85 subjects will be reviewed above the age of 16 years.

Sample size=85     Enrollment=69

Status: currently enrolling

Outcome Measures  

The primary outcome measures are The Achilles tendon Total Rupture Score (ATRS). The ATRS is a methodically validated, disease-specific, patient-completed functional score that was developed using evidence-based methods for the assessment of function relating to acute complete ruptures of the Achilles tendon.

The SF-36 General health survey. The SF-36 is a validated general health survey.

Secondary outcome measures include:

  1. Tendon Achilles re-rupture rate.
  2. Complications:
  3. Calf circumference
  4. Active ankle range of motion Strength, as assessed by standing heel-raise (SHR) test
  5. Adverse Events
  • All outcome measures may be subject to sub-group analysis as stratified according to demographics or other possible confounding factors listed previously.

Contacts

Clinical Research Coordinator -Trish Francis RN   902-473-4136, Pager 902-458-0213  Trish.Francis@nshealth.ca

PI
Dr  Mark Glazebrook

Funding

Unfunded Investigator Initiated

Anticipated Closing date: Dec31/2017

Under Review

Authors: Sam Roberts/Gord Boyd/Mark Glazebrook

Presentations: BOFAS Brighton 2014

Publications: