An interventional study of End-to-end suturation without augmentation and End-to-end suturation with augmentation. in Achilles Tendon Rupture, sponsored by University of Oulu. Completed at 1 site in Finland. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2014-09-16.
Sponsored by University of Oulu · Not applicable, Interventional, and Treatment
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.
557 studies on the registry are indexed under Rupture; 97 are open to participants now.
This study's enrollment of 55 is below the median of 72 across 334 interventional studies indexed under Rupture.
Browse Rupture studies →University of Oulu is the lead sponsor of 138 studies on the registry; 21 are open to participants now.
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Procedure: End-to-end suturation without augmentation
Procedure: End-to-end suturation with 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.
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.
Subjective results in conservative and operative treatment of Achilles tendon rupture.
Subjective results consists of Rand-36 questionnaire and part of Leppilahti-scores questionnaire.
Time frame: 14 years
Objective results in operative treatment of Achilles tendon rupture.
Objective results consists of calf muscle isokinetic strength measurements and MRI-findings.
Time frame: 14 years
Achilles tendon MRI-findings in operative and conservative treatment of achilles tendon rupture
We study calf muscle volume, achilles tendon volume, fat degeneration and achilles tendon elongation.
Time frame: 14 years
This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.
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University of Oulu