ACL TearsNCT07046000
MRI Evaluation of Graft Maturation Following ACL Reconstruction
An observational study of ACL Tears, run by Skye Biologics Holdings, LLC at 1 site in United States.
Trial summary
Post-surgical ACL Graft maturation will be assessed at 4.5, 6, 7.5, 9, 10.5, and 12 months with MRI. Read more about this study
- Who is it for?
- Ages 14 to 50 years
- Conditions the study is for
- ACL Tears
- What is being tested?
- MRI
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2026to Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 14 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Subject who received primary ACL surgery at Houston Methodist Sugar Land.
Who may be able to join
- ACL tear and reconstruction; no other knee ligaments needing reconstruction
- Primary (first-time) ACL tear in the affected knee
- ACL injury occurred less than 12 months before ACL reconstruction
- Have no contraindications or allergies to the treatment administered
- Have current imaging studies (plain radiographs and MRI exams within the past 12 months) of the knee to rule out other etiologic diagnoses
- Patient underwent ACL reconstruction with a Bone-Patellar Tendon-Bone (BTB) graft harvested from the same knee (ipsilateral autograft) with the Active Matrix tissue
- Able and willing to comply with the post-operative study follow-up schedule
Who cannot join
- Prior surgery on the index knee within 12 months of enrollment
- Steroid injection into the index knee within 6 weeks of enrollment
- Chronic ACL tear whereas the injury occurred more than 12 months ago
- Multiligamentous injuries whereas any ligament (MCL, PCL, or PLC) in addition to the ACL needs to be reconstructed
- Patient underwent ACL reconstruction with a hamstring tendon, Achilles tendon or quadriceps tendon graft (any graft other than a patellar tendon BTB)
- Contraindication to MRI (eg, implanted devices incompatible with MRI).
Show all 15Show fewer
- Chrondral lesion of the knee that requires treatment during ACL reconstruction surgery
- History of advanced osteoarthritis of the knee or patella-femoral joint; KL grade III or higher
- History of malignant tumor and osseous metastatic disease,
- History of chronic pain disorders (i.e., fibromyalgia),
- Current substance abuse (drug or alcohol), by the investigator's judgment,
- Females who are pregnant, nursing or breastfeeding, or who intend to become pregnant during participation in the study.
- Currently participating in, or have been recently exited from (within 30 days from enrollment in this study), or plan to enroll in another clinical study for a bone allograft or drug that may impact participation or outcomes of this study,
- Currently involved in any injury litigation or workers compensation claims,
- Has a condition, disorder or other factor that, in the investigator's opinion, would interfere with study participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Houston Methodist Sugar Land
Sugar Land, Texas, 77479
Kyle Borque, MD, 281-690-4678, kaborque@houstonmethodist.org
About this study
Official title: Magnetic Resonance Imaging (MRI) Evaluation of Graft Maturation Following Anterior Cruciate Ligament (ACL) Reconstruction With a Connective Tissue Allograft
Post-surgical ACL Graft maturation will be assessed at 4.5, 6, 7.5, 9, 10.5, and 12 months with MRI.
- Conditions
- ACL Tears
- Being tested
- MRI
- 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.
MRIDiagnostic test
MRI to assess graft maturation
| Study group | Role | What they receive |
|---|---|---|
| ACL Reconstruction with Allograft | Subjects who have undergone ACL reconstruction with allograft Receives: Diagnostic Test: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft Maturation via MRI
The signal to noise ratio will be calculated at the proximal, mid-substance, and distal positions of the graft
Measured: From 4.5 months post surgery until 12 months or graft maturation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start1 Aug 2026 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACL TearsStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Skye Biologics Holdings, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07046000
- Sponsor's protocol ID
- SKY-MRI-ACL-01
- Status last verified
- Apr 2026
- First submitted
- 22 Jun 2025
- Last updated
- 24 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Imaging (MRI) Evaluation of Graft Maturation Following Anterior Cruciate Ligament (ACL) Reconstruction With a Connective Tissue Allograft
- ClinicalTrials.gov ID
- NCT07046000
- Acronym / sponsor ID
- SKY-MRI-ACL-01
- Conditions
- ACL Tears
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Skye Biologics Holdings, LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 1 Jul 2025 (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.
Post-surgical ACL Graft maturation will be assessed at 4.5, 6, 7.5, 9, 10.5, and 12 months with MRI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACL Reconstruction with Allograft | – | Diagnostic Test: MRISubjects who have undergone ACL reconstruction with allograft |
Who may qualify
- Ages
- 14 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Subject who received primary ACL surgery at Houston Methodist Sugar Land.
Key inclusion criteria (7 listed)
- ACL tear and reconstruction; no other knee ligaments needing reconstruction
- Primary (first-time) ACL tear in the affected knee
- ACL injury occurred less than 12 months before ACL reconstruction
- Have no contraindications or allergies to the treatment administered
- Have current imaging studies (plain radiographs and MRI exams within the past 12 months) of the knee to rule out other etiologic diagnoses
Key exclusion criteria (15 listed)
- Prior surgery on the index knee within 12 months of enrollment
- Steroid injection into the index knee within 6 weeks of enrollment
- Chronic ACL tear whereas the injury occurred more than 12 months ago
- Multiligamentous injuries whereas any ligament (MCL, PCL, or PLC) in addition to the ACL needs to be reconstructed
- Patient underwent ACL reconstruction with a hamstring tendon, Achilles tendon or quadriceps tendon graft (any graft other than a patellar tendon BTB)
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 |
|---|---|---|
| MRIMRI to assess graft maturation | Diagnostic test | ACL Reconstruction with Allograft |
Primary outcome
Graft Maturation via MRI
Time frame: From 4.5 months post surgery until 12 months or graft maturation.
The signal to noise ratio will be calculated at the proximal, mid-substance, and distal positions of the graft
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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.
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 ACL Tears, run by Skye Biologics Holdings, LLC at 1 site in United States.
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 7 inclusion and 15 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: opening soon, as of the sponsor's last update on 24 Apr 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kyle Borque, MD (281-690-4678, kaborque@houstonmethodist.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Graft Maturation via MRI (time frame: From 4.5 months post surgery until 12 months or graft maturation.). 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 24 Apr 2026; AzTrials last refreshed its copy on 26 Oct 2026.