Rupture of Posterior Cruciate LigamentPhase 4NCT01440348
Simultaneous Multiple Cruciate Ligament Reconstructions Using a Single Achilles Allograft
A Phase 4 study testing cruciate ligament reconstruction in people with Rupture of Posterior Cruciate Ligament and Rupture of Anterior Cruciate Ligament, run by National Police Hospital at 1 site in South Korea.
Trial summary
This study introduce cases of simultaneous multiple cruciate ligament reconstructions with a single free tendon Achilles allograft using new technique. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Rupture of Posterior Cruciate Ligament, Rupture of Anterior Cruciate Ligament
- What is being tested?
- cruciate ligament reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2011to Sep 2011
- Phase
- Phase 4
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- subjects who had any concomitant meniscus or cartilage injuries
Who cannot join
- subjects who required reconstruction of medial or lateral collateral ligament, or posterolateral ligament complex
- subject who wanted reconstruction with autograft
- subject who denied participation in this study
- subject who would meet the national reimbursement criteria
Trial locations and contacts
1 site in 1 country.
About this study
This study introduce cases of simultaneous multiple cruciate ligament reconstructions with a single free tendon Achilles allograft using new technique.
- Being tested
- cruciate ligament reconstruction
- Keywords
- Achilles allograft, cruciate ligament, reconstruction
- 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.
cruciate ligament reconstructionProcedure or surgery
Multiple cruciate ligament reconstructions with a single Achilles allograft with was divided into two or three strips according to the thickness and length of the allograft.
| Study group | Role | What they receive |
|---|---|---|
| Achilles allograft | Experimental | Not described Receives: Procedure: cruciate ligament reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
circumference and length of the Achilles allograft
After the fresh frozen Achilles allograft was thawed, circumference and length of the tendinous portion of the allograft were measured. According to the circumference and length of the allograft, it was divided into two or three grafts for cruciate ligament reconstruction.
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2011 (estimated)
- Study startMay 2011
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rupture of Posterior Cruciate LigamentStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 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
- NCT01440348
- Sponsor's protocol ID
- NPH2010-001
- Status last verified
- Sep 2011
- First submitted
- 21 Sep 2011
- Last updated
- 26 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simultaneous Multiple Cruciate Ligament Reconstructions Using a Single Achilles Allograft
- ClinicalTrials.gov ID
- NCT01440348
- Acronym / sponsor ID
- NPH2010-001
- Keywords
- Achilles allograft, cruciate ligament, reconstruction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- National Police HospitalOther government
- Study start
- May 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 26 Sep 2011 (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.
This study introduce cases of simultaneous multiple cruciate ligament reconstructions with a single free tendon Achilles allograft using new technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Achilles allograft | Experimental | Procedure: cruciate ligament reconstruction |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- subjects who had any concomitant meniscus or cartilage injuries
Key exclusion criteria (4 listed)
- subjects who required reconstruction of medial or lateral collateral ligament, or posterolateral ligament complex
- subject who wanted reconstruction with autograft
- subject who denied participation in this study
- subject who would meet the national reimbursement criteria
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 |
|---|---|---|
| cruciate ligament reconstructionMultiple cruciate ligament reconstructions with a single Achilles allograft with was divided into two or three strips according to the thickness and length of the allograft. | Procedure or surgery | Achilles allograft |
Primary outcome
circumference and length of the Achilles allograft
Time frame: day 1
After the fresh frozen Achilles allograft was thawed, circumference and length of the tendinous portion of the allograft were measured. According to the circumference and length of the allograft, it was divided into two or three grafts for cruciate ligament reconstruction.
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 2011.
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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 Phase 4 study testing cruciate ligament reconstruction in people with Rupture of Posterior Cruciate Ligament and Rupture of Anterior Cruciate Ligament, 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 1 inclusion and 4 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 2011. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
circumference and length of the Achilles allograft (time frame: day 1). 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 2011.