NCT01063465

Brief Summary

The purpose of this study is to measure the mechanical properties of healing Achilles tendons in humans after early controlled weightbearing, compared with a control group in a randomized, single-blinded trial. The mechanical properties are measured using radiostereophotogrammetic x-rays (RSA). Hypothesis: Early weightbearing improves mechanical properties of the healing Achilles tendon.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

February 1, 2009

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

February 4, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 5, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Last Updated

February 5, 2010

Status Verified

January 1, 2009

Enrollment Period

1.8 years

First QC Date

February 4, 2010

Last Update Submit

February 4, 2010

Conditions

Achilles Tendon RuptureSoft Tissue InjuryTendon Injury

Keywords

AchillesTendonweightbearing

Outcome Measures

Primary Outcomes (1)

  • Modulus of Elasticity

    7 weeks

Study Arms (2)

Early weightbearing

EXPERIMENTAL
Device: Early weightbearing

Control group

EXPERIMENTAL
Device: Early weightbearing

Interventions

Early weightbearingDEVICE

Patients in the intervention group are after 2 weeks supposed to remove the cast twice a day and use a special training pedal for 5 weeks (until cast removal).

Control groupEarly weightbearing

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Acute Achilles Tendon rupture
  • Age between 18 and 60 years

You may not qualify if:

  • Previous rupture of either Achilles tendon
  • Diabetes mellitus
  • History of cancer
  • History of Rheumatoid disease
  • Treatment with steroids
  • Any counterindication for surgical treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Linkoeping

Linköping, 58185, Sweden

RECRUITING

MeSH Terms

Conditions

Soft Tissue InjuriesTendon Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Central Study Contacts

Thorsten Schepull, M.D.

CONTACT

0046-13-224299thorsten.schepull@lio.se

Per Aspenberg, M.D., PhD

CONTACT

0046-13-4166per.aspenberg@liu.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

February 4, 2010

First Posted

February 5, 2010

Study Start

February 1, 2009

Primary Completion

December 1, 2010

Last Updated

February 5, 2010

Record last verified: 2009-01

Locations

SE(1)