Graft HealingNCT03998904
Muscle Preservation Hamstring Graft for ACL Reconstruction
A study testing Muscle preservation and No muscle preservation in people with Graft Healing, run by Hanyang University Seoul Hospital at 1 site in South Korea.
Trial summary
Muscle derived stem cell is a better source of stem cells than a tendon tissue Preservation of muscle derived stem cell may enhance bone-tendon integration and ligamentization of ACL hamstring graft Read more about this study
- Who is it for?
- Ages 16 to 45 years
- Conditions the study is for
- Graft Healing
- What is being tested?
- Muscle preservation and No muscle preservation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jun 2019to 1 Dec 2020
- 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 16 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Primary ACL reconstruction using autogenous hamstring graft
Who cannot join
- Combined meniscal or ligament surgery
- Combined osteoarthritis (KL grade II or more)
- chondral injury more than grade 2
- Refuse to undergo MRI
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Hanyang University Seoul Hospital
Seoul
JIN KYU LEE
About this study
Official title: Muscle Preservation Hamstring Graft for ACL Reconstruction: Randomized Controlled Trial
- Muscle derived stem cell is a better source of stem cells than a tendon tissue
- Preservation of muscle derived stem cell may enhance bone-tendon integration and ligamentization of ACL hamstring graft
- Conditions
- Graft Healing
- Being tested
- Muscle preservation, No muscle preservation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle preservationProcedure or surgery
Muscle preservation during graft preparation of hamstring graft
No muscle preservationProcedure or surgery
No muscle preservation during graft preparation of hamstring graft
| Study group | Role | What they receive |
|---|---|---|
| Muscle preservation | Experimental | Muscle preservation for hamsting graft Receives: Procedure: Muscle preservation |
| None preservation | Active comparator | No muscle preservation for hamstring graft Receives: Procedure: No muscle preservation |
What is being measured
The primary outcome is the main question the study is designed to answer.
SNQ value of MRI
signal of ACL graft-signal of quadriceps tendon/singal of background
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2019
- Study start1 Jun 2019
- Primary completion1 Jun 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graft HealingStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanyang University Seoul Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JIN KYU LEE, Hanyang University Seoul Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03998904
- Sponsor's protocol ID
- muscle preservation study
- Status last verified
- Jun 2019
- First submitted
- 25 Jun 2019
- Last updated
- 26 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no planned for now
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle Preservation Hamstring Graft for ACL Reconstruction: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03998904
- Acronym / sponsor ID
- muscle preservation study
- Conditions
- Graft Healing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Hanyang University Seoul HospitalUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Jun 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 26 Jun 2019 (actual)
- 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.
- Muscle derived stem cell is a better source of stem cells than a tendon tissue
- Preservation of muscle derived stem cell may enhance bone-tendon integration and ligamentization of ACL hamstring graft
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Muscle preservation | Experimental | Procedure: Muscle preservationMuscle preservation for hamsting graft |
| None preservation | Active comparator | Procedure: No muscle preservationNo muscle preservation for hamstring graft |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Primary ACL reconstruction using autogenous hamstring graft
Key exclusion criteria (4 listed)
- Combined meniscal or ligament surgery
- Combined osteoarthritis (KL grade II or more)
- chondral injury more than grade 2
- Refuse to undergo MRI
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 |
|---|---|---|
| Muscle preservationMuscle preservation during graft preparation of hamstring graft | Procedure or surgery | Muscle preservation |
| No muscle preservationNo muscle preservation during graft preparation of hamstring graft | Procedure or surgery | None preservation |
Primary outcome
SNQ value of MRI
Time frame: 6 months
signal of ACL graft-signal of quadriceps tendon/singal of background
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2019.
- Individual participant dataSharing planned: No. no planned for now
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Muscle preservation and No muscle preservation in people with Graft Healing, run by Hanyang University Seoul 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: status not confirmed, as of the sponsor's last update on 26 Jun 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact JIN KYU LEE, MD (820222908485, gaia-silver@hnamail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SNQ value of MRI (time frame: 6 months). 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 Jun 2019.