Viewing Study NCT00489749



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Study NCT ID: NCT00489749
Status: COMPLETED
Last Update Posted: 2007-06-21
First Post: 2007-06-19

Brief Title: A Study Comparing Protected Early Weightbearing Versus Non-Weightbearing After Surgery for Achilles Tendon Rupture
Sponsor: University of Alberta
Organization: University of Alberta

Study Overview

Official Title: The Influence of Protected Early Weightbearing Versus Nonweightbearing After Surgical Repair of the Achilles Tendon
Status: COMPLETED
Status Verified Date: 2007-06
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 purpose of this study was to determine the effect of protected early weightbearing PEWB compared to non-weightbearing NWB after surgery for an Achilles tendon rupture ATR on health related quality of life HRQL in the initial six week period after surgery functional recovery over time return to work and activity and complications We hypothesized that PEWB following ATR repair would result in i improved HRQL in the initial postoperative period ii a quicker recovery of HRQL strength and endurance iii earlier return to work and sport and iv no increase in complications such as re-rupture compared to NWB
Detailed Description: Achilles tendon rupture ATR is commonly treated with open surgical repair Following surgical repair there are a variety of protocols ranging from complete immobilization to immediate postoperative mobilization with early weightbearing However no clear consensus regarding the optimal postoperative rehabilitation protocol for ATRs exists Early rehabilitation after ATR has been shown to be beneficial in animal and human studies Human prospective studies and randomized controlled trials have shown that early postoperative mobilization do not pose additional risks compared to cast immobilization with a trend toward a reduction in lost work days and an earlier return to sport However these trials define early postoperative mobilization differently ie use different combinations of weightbearing and range of motion This makes it difficult to determine which factor in the early rehabilitation process plays an important role in optimizing recovery An important component of early rehabilitation is weightbearing

Comparison Patients weightbearing in the early rehabilitation period after surgical repair of the Achilles tendon compared to patients non-weightbearing after the surgical repair of the Achilles tendon repair With the exception of weightbearing status both groups performed the same rehabilitation program

Study Oversight

Has Oversight DMC: None
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?: None