Clinical Trials Directory

Trials / Completed

CompletedNCT02018224

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
55 (actual)
Sponsor
University of Oulu · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

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

Timeline

Start date
1998-10-01
Primary completion
2014-03-01
First posted
2013-12-23
Last updated
2014-09-16

Locations

1 site across 1 country: Finland

Source: ClinicalTrials.gov record NCT02018224. Inclusion in this directory is not an endorsement.