- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01693757
Functional Outcome Anterior Cruciate Ligament Reconstruction
September 24, 2012 updated by: Farshid Mohammadi, University of Social Welfare and Rehabilitation Science
Comparison of Functional Outcome Measures of Anterior Cruciate Ligament Reconstruction Using Either Patellar Tendon or Hamstring Tendon Grafts and Controls in Competitive Soccer Players: A Randomized Trial
The purpose of this study is to compare hop performance and jump landing strategy in soccer players with higher level sports activities after ACLR using either BPTB or STG and controls.
Study Overview
Status
Completed
Detailed Description
The choice of graft for anterior cruciate ligament reconstruction (ACLR) remains controversial.
Despite the need for outcome studies comparing bone-patellar tendon-bone (BPTB) with semitendinosus and gracilis tendon (STG), few studies have evaluated functional outcomes.
The objective of the current study was to compare hop performance and jump landing strategy in soccer players with higher level sports activities after ACLR using either BPTB or STG and controls.
Study Type
Observational
Enrollment (Actual)
63
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Tehran, Iran, Islamic Republic of
- USWR
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 30 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Sampling Method
Probability Sample
Study Population
The patients with ACL deficiency were invited to participate in a randomized trial comparing ACLR with either a BPTB or STG graft.
Description
Inclusion Criteria:
- ACLR and controls.
Exclusion Criteria:
- Musculoskeletal injuries
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Control
Healthy
|
|
BPTB group
Bone-patellar tendon-bone
|
|
STG group
Semitendinosus and gracilis tendon
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Hop values for the both legs in Single, 6-m, Cross-over and Triple hops
Time Frame: Patients were followed up to 8 months post-surgery
|
Patients were followed up to 8 months post-surgery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Landing and Take-off Ground Reaction Forces
Time Frame: Patients were followed up to 8 months post-surgery
|
Patients were followed up to 8 months post-surgery
|
|
Strength of Quadriceps and Hamstrings
Time Frame: Patients were followed up to 8 months post-surgery
|
Patients were followed up to 8 months post-surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Mahyar Salavati, Professor, USWR
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (Actual)
January 1, 2011
Study Completion (Actual)
March 1, 2011
Study Registration Dates
First Submitted
May 25, 2012
First Submitted That Met QC Criteria
September 24, 2012
First Posted (Estimate)
September 26, 2012
Study Record Updates
Last Update Posted (Estimate)
September 26, 2012
Last Update Submitted That Met QC Criteria
September 24, 2012
Last Verified
September 1, 2012
More Information
Terms related to this study
Other Study ID Numbers
- 3
- USWR (Other Identifier: USWR)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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