NCT02012803

Brief Summary

The intention is to compare prospectively operative and conservative early functional rehabilitation protocol in treatment of total achilles tendon rupture. To compare these treatments, the investigators use 1998 published Leppilahti-score, Rand-36 quality of life-questionnaire and MRI. The Leppilahti-score includes both subjective and objective items (pain, stiffness, subjective calf muscle weakness, footwear restrictions, active range of motion between ankles, subjective result, isokinetic calf muscle strength). The investigators also study MRI-imaging for both legs and compare including achilles tendon elongation and muscle volume correlations to Leppilahti-score results between these two treatments. Follow-up time is 18 months. Hypothesis is that operative treatment offers no benefit in comparison conservative treatment, with identical rehabilitation protocol.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2009

Longer than P75 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

April 1, 2009

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

November 27, 2013

Completed
19 days until next milestone

First Posted

Study publicly available on registry

December 16, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

October 11, 2018

Status Verified

October 1, 2018

Enrollment Period

6.7 years

First QC Date

November 27, 2013

Last Update Submit

October 10, 2018

Conditions

Achilles Tendon Rupture

Keywords

Achilles tendon rupturetreatment, elongationoperative treatment of achilles tendon ruptureconservative treatment of achilles tendon rupture

Outcome Measures

Primary Outcomes (1)

  • Subjective and objective results in conservative and operative treatment of Achilles tendon rupture.

    Subjective results consists of Rand-36 questionnaire and part of Leppilahti-scores questionnaire. Objective results consists of calf muscle isokinetic strength measurements and MRI-findings.

    18 months

Secondary Outcomes (2)

  • Complications in treatment of achilles tendon rupture.

    18 months

  • Achilles tendon MRI-findings in operative and conservative treatment of achilles tendon rupture.

    18 months

Study Arms (2)

Operative treatment

EXPERIMENTAL
Procedure: End to end suturation by Krackow locking loop surgical technique with 2-Fiber-Wire suture

conservative treatment

ACTIVE COMPARATOR
Other: Conservative treatment of achilles tendon rupture

Interventions

End to end suturation by Krackow locking loop surgical technique with 2-Fiber-Wire suturePROCEDURE

Operative treatment of achilles tendon rupture; End to end suturation by Krackow locking loop surgical technique with 2-Fiber-Wire suture and after operation identical protocol as conservative treatment.

Operative treatment
Conservative treatment of achilles tendon ruptureOTHER

Conservative treatment of achilles tendon rupture; 1 week equinus-cast without bearing, and then 6 week Vacoped orthosis with different equinus degrees and full weight bearing.

conservative treatment

Eligibility Criteria

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

You may qualify if:

  • years, Clinical diagnosis of total achilles tendon rupture, ultrasonography controlled tendon ends reposition when ankle is in equinus/ plantar flexion.

You may not qualify if:

  • earlier achilles tendon disorders, corticosteroid injections in achilles tendon, fluorokinolol-antibiotics in 2 years earlier, systemic corticosteroid medication, diabetes, peripheral arterial disease, more than 7 days old rupture, patient lives abroad or patient refused to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oulu University Hospital

Oulu, 90220, Finland

Location

Related Publications (2)

  • Heikkinen J, Lantto I, Flinkkila T, Ohtonen P, Niinimaki J, Siira P, Laine V, Leppilahti J. Soleus Atrophy Is Common After the Nonsurgical Treatment of Acute Achilles Tendon Ruptures: A Randomized Clinical Trial Comparing Surgical and Nonsurgical Functional Treatments. Am J Sports Med. 2017 May;45(6):1395-1404. doi: 10.1177/0363546517694610. Epub 2017 Mar 10.

    PMID: 28282504DERIVED

  • Lantto I, Heikkinen J, Flinkkila T, Ohtonen P, Siira P, Laine V, Leppilahti J. A Prospective Randomized Trial Comparing Surgical and Nonsurgical Treatments of Acute Achilles Tendon Ruptures. Am J Sports Med. 2016 Sep;44(9):2406-14. doi: 10.1177/0363546516651060. Epub 2016 Jun 15.

    PMID: 27307495DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2013

First Posted

December 16, 2013

Study Start

April 1, 2009

Primary Completion

December 1, 2015

Study Completion

December 1, 2017

Last Updated

October 11, 2018

Record last verified: 2018-10

Locations

FI(1)