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Completed

NCT Number: NCT02018224

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

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.

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Key information

Conditions

Achilles Tendon Rupture

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oulu University Hospital

Oulu, 90220, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

End-to-end suturation without augmentation

Procedure

End-to-end suturation without augmentation; Irregular tendon ends were cleaned and repaired by the Krackow technique with two separate 0-gauge absorbable sutures.

End-to-end suturation with augmentation.

Procedure

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.

Primary outcomes

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

    Time frame: 14 years

    Subjective results consists of Rand-36 questionnaire and part of Leppilahti-scores questionnaire.

  2. Objective results in operative treatment of Achilles tendon rupture.

    Time frame: 14 years

    Objective results consists of calf muscle isokinetic strength measurements and MRI-findings.

Secondary outcomes

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

    Time frame: 14 years

    We study calf muscle volume, achilles tendon volume, fat degeneration and achilles tendon elongation.

Sponsors and collaborators

Lead sponsor

University of Oulu

Other

Registry information

Important dates

Study start
1998
Primary completion
2014
First posted
Dec 23, 2013
Registry last updated
Sep 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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