NCT00489749

Brief Summary

The purpose of this study was to determine the effect of protected early weightbearing (PEWB) compared to non-weightbearing (NWB) after surgery for an Achilles tendon rupture (ATR) on health related quality of life (HRQL) in the initial six week period after surgery, functional recovery over time, return to work and activity and complications. We hypothesized that PEWB following ATR repair would result in: i) improved HRQL in the initial postoperative period, ii), a quicker recovery of HRQL, strength and endurance, iii) earlier return to work and sport, and iv) no increase in complications, such as re-rupture compared to NWB.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2003

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2007

Completed
Last Updated

June 21, 2007

Status Verified

June 1, 2007

First QC Date

June 19, 2007

Last Update Submit

June 19, 2007

Conditions

Achilles Tendon Rupture

Keywords

Achilles tendon ruptureOpen surgical repairEarly functional mobilizationWeightbearingRehabilitation

Outcome Measures

Primary Outcomes (1)

  • Health related quality of life: Short form 36 questionnaire

    six weeks

Secondary Outcomes (9)

  • Health related quality of life: Short Form-36 questionnaire

    3 and 6 months

  • Level of activity: tailored question

    six weeks, 3 months, and 6 months

  • Major complications: chart review

    6 weeks, 3 months, and 6 months

  • Minor complications: chart review

    6 weeks, 3 months, and 6 months

  • Isometric muscle strength: hand held myometer

    6 weeks, 3 months, and 6 months

  • +4 more secondary outcomes

Interventions

Protected early weightbearing/Achilles tendon surgeryPROCEDURE

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • closed and complete Achilles tendon rupture
  • seen within 14 days of injury in hospital

You may not qualify if:

  • unwilling to follow the study's rehabilitation protocol
  • unable to speak or read English
  • co-morbid conditions such as diabetes and neurological or collagen disease
  • pregnancy
  • recent immunosuppressant or fluoroquinolone therapy
  • previous Achilles tendon symptoms
  • previous ipsilateral rupture
  • sustained an additional injury not allowing weightbearing
  • an Achilles tendon avulsion injury
  • unfit for surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

Study Officials

  • Nadr Jomha, MD, PhD

    University of Alberta Division of Orthopaedic Surgery

    PRINCIPAL INVESTIGATOR

  • Amar Suchak, MD

    University of Alberta Department of Medicine and Dentistry

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 19, 2007

First Posted

June 21, 2007

Study Start

October 1, 2003

Study Completion

May 1, 2006

Last Updated

June 21, 2007

Record last verified: 2007-06

Locations

CA(1)