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
| Type | Name | Description |
|---|---|---|
| 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. |
| PROCEDURE | 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. |
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.