Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2025-12-27 @ 7:04 AM
Study NCT ID:
NCT02012803
Status:
COMPLETED
Last Update Posted:
2018-10-11
First Post:
2013-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Achilles Tendon Rupture, Conservative vs. Operative Treatment: Prospective Randomized Controlled Trial
Sponsor:
University of Oulu
Organization:
Study Overview
Official Title:
Conservative vs. Operative Treatment of Achilles Tendon Rupture, Prospective Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The intention is to compare prospectively operative and conservative early functional rehabilitation protocol in treatment of total achilles tendon rupture. To compare these treatments, the investigators use 1998 published Leppilahti-score, Rand-36 quality of life-questionnaire and MRI. The Leppilahti-score includes both subjective and objective items (pain, stiffness, subjective calf muscle weakness, footwear restrictions, active range of motion between ankles, subjective result, isokinetic calf muscle strength). The investigators also study MRI-imaging for both legs and compare including achilles tendon elongation and muscle volume correlations to Leppilahti-score results between these two treatments. Follow-up time is 18 months.
Hypothesis is that operative treatment offers no benefit in comparison conservative treatment, with identical rehabilitation protocol.
Hypothesis is that operative treatment offers no benefit in comparison conservative treatment, with identical rehabilitation protocol.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: