Trial record 3 of 21 for:    Open Studies | "Achilles Tendon"

Achilles Tendon Rupture, Comparison Two Different Operative Techniques. Prospective Randomized Controlled Trial. 14 Years Follow-up.

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Oulu
Sponsor:
Information provided by (Responsible Party):
University of Oulu
ClinicalTrials.gov Identifier:
NCT02018224
First received: November 27, 2013
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

The intention is to compare 60 patients with Achilles tendon rupture, who where randomized in 1998-2001 preoperatively to receive end-to-end suturation by the Krackow locking loop technique either without augmentation or with one central down-turned gastrocnemius fascia flap (Silfverskjöld). Postoperative care was identical for both groups; A brace allowed free active plantar flexion of the ankle postoperatively, whereas dorsiflexion was restricted to neutral for the first three weeks. Weight bearing was limited for six weeks. To compare these treatments, we use 1998 published Leppilahti-score, Rand-36 quality of life-questionnaire and MRI. Mean follow-up time is 14 years.

Hypothesis; Augmentation with a down-turned gastrocnemius fascia flap does not provide better result than would end-to-end suture repair with use of the Krackow locking loop surgical technique in long-term follow up.


Condition Intervention
Achilles Tendon Rupture
Procedure: End-to-end suturation without augmentation
Procedure: End-to-end suturation with augmentation.

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Achilles Tendon Rupture, Comparison Two Different Operative Techniques. Prospective Randomized Controlled Trial. 14 Years Follow-up.

Further study details as provided by University of Oulu:

Primary Outcome Measures:
  • Subjective results in conservative and operative treatment of Achilles tendon rupture. [ Time Frame: 14 years ] [ Designated as safety issue: No ]
    Subjective results consists of Rand-36 questionnaire and part of Leppilahti-scores questionnaire.

  • Objective results in operative treatment of Achilles tendon rupture. [ Time Frame: 14 years ] [ Designated as safety issue: No ]
    Objective results consists of calf muscle isokinetic strength measurements and MRI-findings.


Secondary Outcome Measures:
  • Achilles tendon MRI-findings in operative and conservative treatment of achilles tendon rupture [ Time Frame: 14 years ] [ Designated as safety issue: No ]
    We study calf muscle volume, achilles tendon volume, fat degeneration and achilles tendon elongation.


Estimated Enrollment: 60
Study Start Date: October 1998
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: End-to-end suturation without augmentation Procedure: End-to-end suturation without augmentation
End-to-end suturation without augmentation; Irregular tendon ends were cleaned and repaired by the Krackow technique with two separate 0-gauge absorbable sutures.
Experimental: End-to-end suturation with augmentation Procedure: End-to-end suturation with augmentation.
End-to-end suturation with augmentation; End-to-end suturation as above with a 10 mm wide central gastrocnemius aponeurosis flap, as proposed by Silfverskjöld.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Total achilles tendon rupture diagnose.

Exclusion Criteria:

  • more than 7 days old rupture, local corticosteroids injection in around the achilles tendon, rupture was open/ there where skin problems over achilles tendon area, patient lived abroad, if the main author was unavailable, or patient refused to participate.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02018224

Contacts
Contact: Juuso Heikkinen, medical student +358407031233 juuso.heikkinen@student.oulu.fi
Contact: Iikka Lantto, specialist +3588 315 2841 Iikka.Lantto@ppshp.fi

Locations
Finland
Oulu University Hospital Recruiting
Oulu, Finland, 90220
Contact: Juhana Leppilahti, Professor    +3588 315 2454    juhana.leppilahti@ppshp.fi   
Sponsors and Collaborators
University of Oulu
  More Information

No publications provided

Responsible Party: University of Oulu
ClinicalTrials.gov Identifier: NCT02018224     History of Changes
Other Study ID Numbers: evo-rad-akilles3
Study First Received: November 27, 2013
Last Updated: December 16, 2013
Health Authority: Finland: Ethics Committee

Keywords provided by University of Oulu:
Achilles tendon rupture, operative treatment, elongation, long-term follow up.

Additional relevant MeSH terms:
Rupture
Wounds and Injuries

ClinicalTrials.gov processed this record on September 11, 2014