Anterior Cruciate Ligament RuptureNCT01533025
Single Bundle Anterior Cruciate Ligament Reconstruction in Active Young Men
A study testing anterior cruciate ligament reconstruction in people with Anterior Cruciate Ligament Rupture, run by National Police Hospital at 1 site in South Korea.
Trial summary
The clinical outcomes of anterior cruciate ligament reconstruction using free tendon Achilles allograft are comparable to those using Achilles allograft with bone block on its end. Read more about this study
- Who is it for?
- Ages 19 to 45 years, men only
- Conditions the study is for
- Anterior Cruciate Ligament Rupture
- What is being tested?
- anterior cruciate ligament reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2008to Jan 2012
- Phase
- Interventional
- 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 19 to 45 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- male subjects
- subjects who had concomitant medial collateral ligament injury which was managed conservatively
- subjects who had meniscus tear which was managed by partial meniscectomy
Who cannot join
- subjects who underwent a subtotal or total meniscectomy, meniscal repair, or meniscal transplantation due to meniscus injury
- subjects who underwent an operation due to any concomitant ipsilateral ligament injuries
- subjects who underwent microfracture or cartilage transplantation due to full thickness cartilage injury
- female
- subjects who were older than 45
- subjects who had histories of injuries on either knee
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Bundle Anterior Cruciate Ligament Reconstruction in Active Young Men: Free Tendon Achilles Allograft vs. Bone-tendon Achilles Allograft
The clinical outcomes of anterior cruciate ligament reconstruction using free tendon Achilles allograft are comparable to those using Achilles allograft with bone block on its end.
- Conditions
- Anterior Cruciate Ligament Rupture
- Being tested
- anterior cruciate ligament reconstruction
- Keywords
- anterior cruciate ligament, Achilles, free tendon, bone-tendon, free tendon Achilles allograft, Achilles allograft with calcaneal bone block on its end
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anterior cruciate ligament reconstructionProcedure or surgery
single bundle anterior cruciate ligament reconstruction with Achilles allograft
| Study group | Role | What they receive |
|---|---|---|
| bone-tendon Achilles allograft group | Active comparator | the group which underwent anterior cruciate ligament reconstruction using bone-tendon Achilles allograft Receives: Procedure: anterior cruciate ligament reconstruction |
| free tendon Achilles allogarft group | Active comparator | the group which underwent anterior cruciate ligament reconstruction using free tendon Achilles allograft Receives: Procedure: anterior cruciate ligament reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lysholm score
Measured: 2 years
Secondary outcomes (1)
side-to-side differences
the differences of anterior displacement of tibia under loading between normal knee and reconstructed knee
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2012 (estimated)
- Study startAug 2008
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament RuptureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Police Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Jung Ho Noh, National Police Hospital
- Investigators
- Jung Ho Noh, M.D., Ph.D., Principal investigator, National Police Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01533025
- Sponsor's protocol ID
- NPH2008-007
- Status last verified
- Feb 2012
- First submitted
- 10 Feb 2012
- Last updated
- 15 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Bundle Anterior Cruciate Ligament Reconstruction in Active Young Men: Free Tendon Achilles Allograft vs. Bone-tendon Achilles Allograft
- ClinicalTrials.gov ID
- NCT01533025
- Acronym / sponsor ID
- NPH2008-007
- Conditions
- Anterior Cruciate Ligament Rupture
- Keywords
- anterior cruciate ligament, Achilles, free tendon, bone-tendon, free tendon Achilles allograft, Achilles allograft with calcaneal bone block on its end
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- National Police HospitalOther government
- Study start
- Aug 2008
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 15 Feb 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 clinical outcomes of anterior cruciate ligament reconstruction using free tendon Achilles allograft are comparable to those using Achilles allograft with bone block on its end.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bone-tendon Achilles allograft group | Active comparator | Procedure: anterior cruciate ligament reconstructionthe group which underwent anterior cruciate ligament reconstruction using bone-tendon Achilles allograft |
| free tendon Achilles allogarft group | Active comparator | Procedure: anterior cruciate ligament reconstructionthe group which underwent anterior cruciate ligament reconstruction using free tendon Achilles allograft |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- male subjects
- subjects who had concomitant medial collateral ligament injury which was managed conservatively
- subjects who had meniscus tear which was managed by partial meniscectomy
Key exclusion criteria (6 listed)
- subjects who underwent a subtotal or total meniscectomy, meniscal repair, or meniscal transplantation due to meniscus injury
- subjects who underwent an operation due to any concomitant ipsilateral ligament injuries
- subjects who underwent microfracture or cartilage transplantation due to full thickness cartilage injury
- female
- subjects who were older than 45
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anterior cruciate ligament reconstructionsingle bundle anterior cruciate ligament reconstruction with Achilles allograft | Procedure or surgery | bone-tendon Achilles allograft group, free tendon Achilles allogarft group |
Primary outcome
Lysholm score
Time frame: 2 years
1 secondary outcome
side-to-side differences
Time frame: 2 years
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 15 Feb 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.
Jung Ho Noh, M.D., Ph.D. principal investigator
National Police Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing anterior cruciate ligament reconstruction in people with Anterior Cruciate Ligament Rupture, run by National Police Hospital at 1 site in South Korea.
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 3 inclusion and 6 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 15 Feb 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 South Korea. 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?
Lysholm score (time frame: 2 years). 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 15 Feb 2012.