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

Achilles Tendon Rupture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02018224
• Other study ID #: evo-rad-akilles3
• Status: Completed
• Phase: N/A
• First received: November 27, 2013
• Last updated: September 15, 2014
• Start date: October 1998

Study information

• Verified date: September 2014
• Source: University of Oulu
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Achilles Tendon Rupture
• Rupture

Intervention

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.
• 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.

Locations

Country	Name	City	State
Finland	Oulu University Hospital	Oulu

Sponsors (1)

Lead Sponsor	Collaborator
University of Oulu

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective results in conservative and operative treatment of Achilles tendon rupture.	Subjective results consists of Rand-36 questionnaire and part of Leppilahti-scores questionnaire.	14 years	No
Primary	Objective results in operative treatment of Achilles tendon rupture.	Objective results consists of calf muscle isokinetic strength measurements and MRI-findings.	14 years	No
Secondary	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.	14 years	No