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

NCT02018224 | Completed

• 1 other identifier: evo-rad-akilles3
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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

Achilles Tendon Rupture

Keywords

Achilles tendon rupture, operative treatment, elongation, long-term follow up.

Outcome Measures

Primary Outcomes (2)

• 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

• Objective results in operative treatment of Achilles tendon rupture.

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

  14 years

Secondary Outcomes (1)

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

  14 years

Study Arms (2)

End-to-end suturation without augmentation

EXPERIMENTAL

Procedure: End-to-end suturation without augmentation

End-to-end suturation with augmentation

EXPERIMENTAL

Procedure: End-to-end suturation with augmentation.

Interventions

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 without augmentation

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.

End-to-end suturation with augmentation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Total achilles tendon rupture diagnose.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oulu: lead

Study Sites (1)

Oulu University Hospital

Oulu, 90220, Finland

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2013
• First Posted: December 23, 2013
• Study Start: October 1, 1998
• Primary Completion: March 1, 2014
• Last Updated: September 16, 2014

Record last verified: 2014-09

Locations

FI (1)