Complications of Surgical Procedures or Medical CareNCT01693757
Functional Outcome Anterior Cruciate Ligament Reconstruction
An observational study of Complications of Surgical Procedures or Medical Care, run by University of Social Welfare and Rehabilitation Science at 1 site in Iran.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Complications of Surgical Procedures or Medical Care
- How many people
- 63 participants
- Where
- 1 siteIran
- Study dates
- Jan 2010to Mar 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: The patients with ACL deficiency were invited to participate in a randomized trial comparing ACLR with either a BPTB or STG graft.
Who may be able to join
- ACLR and controls.
Who cannot join
- Musculoskeletal injuries
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Keywords
- Anterior Cruciate Ligament, Hamstrings versus patellar tendon, Hop test, Return to sports
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| BPTB group | Bone-patellar tendon-bone | |
| STG group | Semitendinosus and gracilis tendon | |
| Control | Healthy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hop values for the both legs in Single, 6-m, Cross-over and Triple hops
Measured: Patients were followed up to 8 months post-surgery
Secondary outcomes (2)
Landing and Take-off Ground Reaction Forces
Measured: Patients were followed up to 8 months post-surgery
Strength of Quadriceps and Hamstrings
Measured: Patients were followed up to 8 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2012 (estimated)
- Study startJan 2010
- Primary completionJan 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complications of Surgical Procedures or Medical CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Social Welfare and Rehabilitation Science
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Farshid Mohammadi, University of Social Welfare and Rehabilitation Science
- Investigators
- Mahyar Salavati, Professor, Study director, USWR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01693757
- Sponsor's protocol ID
- 3
- Other IDs
- USWR
- Status last verified
- Sep 2012
- First submitted
- 25 May 2012
- Last updated
- 26 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01693757
- Acronym / sponsor ID
- 3
- Keywords
- Anterior Cruciate Ligament, Hamstrings versus patellar tendon, Hop test, Return to sports
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- University of Social Welfare and Rehabilitation ScienceUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 26 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BPTB group | – | –Bone-patellar tendon-bone |
| STG group | – | –Semitendinosus and gracilis tendon |
| Control | – | –Healthy |
Who may qualify
- Ages
- 21 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The patients with ACL deficiency were invited to participate in a randomized trial comparing ACLR with either a BPTB or STG graft.
Key inclusion criteria (1 listed)
- ACLR and controls.
Key exclusion criteria (1 listed)
- Musculoskeletal injuries
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
Landing and Take-off Ground Reaction Forces
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahyar Salavati, Professor study director
USWR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complications of Surgical Procedures or Medical Care, run by University of Social Welfare and Rehabilitation Science at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2012.