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

U

University of Oulu

Status

Completed

Conditions

Achilles Tendon Rupture

Treatments

Procedure: End-to-end suturation without augmentation
Procedure: End-to-end suturation with augmentation.

Study type

Interventional

Funder types

Other

Identifiers

NCT02018224
evo-rad-akilles3

Details and patient eligibility

About

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.

Enrollment

55 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

55 participants in 2 patient groups

End-to-end suturation without augmentation
Experimental group
Treatment:
Procedure: End-to-end suturation without augmentation
End-to-end suturation with augmentation
Experimental group
Treatment:
Procedure: End-to-end suturation with augmentation.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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