Anterior Cruciate Ligament TearPhase 4NCT06511232
Intraosseous Morphine Administration During Anterior Cruciate Ligament Reconstruction
A Phase 4 study testing Intraosseous Morphine in people with Anterior Cruciate Ligament Tear and Anterior Cruciate Ligament Injuries, run by The Methodist Hospital Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to determine if intraosseous (IO) morphine decreases pain and post-operative opioid use in patients undergoing anterior cruciate ligament (ACL) reconstruction. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Anterior Cruciate Ligament Tear, Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
- What is being tested?
- Intraosseous Morphine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2024to 31 Jul 2029
- Phase
- Phase 4
- 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients of the IRB approved surgeon(s) undergoing ACL reconstruction with bone-to-bone (BTB) autograft
- Patients aged between 18-40 years old at the time of surgery
Who cannot join
- Patients undergoing ACL reconstruction with any other type of autograft or allograft other than BTB
- Patients younger than 18 years old or older than 40 years old
- Patients undergoing meniscal root repair or any other repair that changes their weight-bearing status
- Patients with a history of substance abuse
- Vulnerable populations
- Patients on chronic pain medication within the last 6 months
Show all 10Show fewer
- BMI >/= 35
- Allergy to morphine
- Unwilling to participate
- Any additional reason the PI deems reasonable
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, 1 recruiting
- Recruiting
Houston Methodist Research Institute
Houston, Texas, 77030
Haley Goble
About this study
Official title: Intraosseous Morphine Administration During Anterior Cruciate Ligament Reconstruction: A Randomized Control Trial
The purpose of this study is to determine if intraosseous (IO) morphine decreases pain and post-operative opioid use in patients undergoing anterior cruciate ligament (ACL) reconstruction.
- Conditions
- Anterior Cruciate Ligament Tear, Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
- Being tested
- Intraosseous Morphine
- 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.
Intraosseous MorphineDrug
Also called Duramorph, Astramorph PF, Infumorph
More recently, intraosseous infusion of analgesics and antibiotics has gained traction in the total joint arthroplasty literature. In knee arthroplasty patients, the combination of a spine and adductor canal block with an intraosseous infusion of morphine into the tibial tubercle prior to incision yielded lower pain in the immediate postoperative period and at 2 weeks, less pain medication use, and significantly better patient-reported outcomes while also reducing systemic opioid exposure in the early postoperative period compared to the spine and adductor block alone.3 No study to date in the available literature has evaluated the efficacy of intraosseous morphine infusion in managing acute postoperative pain in patients undergoing ACL reconstruction with bone-patellar tendon-bone autograft, so that is the intended evaluation point with this project.
| Study group | Role | What they receive |
|---|---|---|
| Intraosseous Injection of Morphine | Experimental | The intervention group will receive an intraosseous (IO) injection of 10mg of morphine mixed with up to 100mg of saline into the tibial tubercle during a standard ACL reconstruction. Receives: Drug: Intraosseous Morphine |
| Standard of Care Morphine Administration | No intervention | The control group will receive the standard of care treatment, which is no IO injection during a standard ACL reconstruction. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Pain Levels in the Post-Operative Period as assessed by a patient-reported post operative symptom journal.
The study will measure patient-reported levels of pain on a daily basis (for a total of two weeks) with a symptom journal, which will ask patients to report on a variety of pain-related outcomes including levels of pain throughout different times of day, levels of nausea throughout different times of the day, and what pain medication(s) they are taking and at what time.
Measured: 2 weeks postop, 6 weeks postop, 12 weeks postop
Changes in Post-Operative Opioid Use
To examine if the use of IO morphine will result in different levels of post-operative opioid use compared to SOC administration of morphine. This outcome will be assessed utilizing the daily symptom journal which will ask patients to complete daily logs of the pain medication that they take (what kind, what dose, when they took it, etc.) for two weeks following their operation.
Measured: 2 weeks postop
Patient Pain Levels in the Post-Operative Period as assessed by the Lysholm Knee Survey
Participants will be asked to complete the Lysholm Knee survey at 2, 6, and 12 weeks postop which will assess patient progress following surgery such as pain, swelling, climbing stairs, using a crutch, etc. The Lysholm scale consists of eight items with each question response being assigned an arbitrary score on an increasing scale. The total score is the sum of each response to the eight questions and may range from 0-100 where higher scores indicate a better outcome with fewer symptoms or disability.
Measured: 2 weeks postop, 6 weeks postop, 12 weeks postop
Secondary outcomes (3)
Patient Range of Motion in the Post-Operative Period as assessed by the KOOS, JR Knee Survey
Patients will complete the KOOS, JR. Knee Survey to self-report their level of difficulty/pain (from none to extreme) certain movements have caused them. KOOS, JR is scored by summing the raw response (range 0-28) and then converting it to an interval score. The interval score ranges from 0 to 100 where 0 represents total knee disability and 100 represents perfect knee health.
Measured: Preop, 2 weeks postop, 6 weeks postop, 12 weeks postop
Patient Activity Level in the Post-Operative Period as assessed by the Tegner scale.
Patients will complete the Tegner Activity Level Survey which will ask them to self-report their pre-operative and post-operative level of activity. The rating system scores a person's activity level between 0 and 10, where 0 is "sick leave or disability pension because of knee problems" and 10 is "participation in competitive sports such as soccer at a national or international elite level." As such, a higher score reflects better outcomes on this measure.
Measured: Preop, 2 weeks postop, 6 weeks postop, 12 weeks postop
Patient Range of Motion in the Post-Operative Period as assessed by the Lysholm Knee Survey
The Lysholm Knee Survey will ask specific questions with a variety of responses to reflect movement-ability responses such as the use of a cane, the presence of a limp, squatting, climbing stairs, etc.The Lysholm scale consists of eight items with each question response being assigned an arbitrary score on an increasing scale. The total score is the sum of each response to the eight questions and may range from 0-100 where higher scores indicate a better outcome with fewer symptoms or disability.
Measured: 2 weeks postop, 6 weeks postop, 12 weeks postop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start19 Aug 2024
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament TearStudies of the same condition, open and under way.
- More trials run by The Methodist Hospital Research InstituteThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a single-blind randomized controlled trial with two arms, 1) Intervention and 2) control. The intervention group will receive an intraosseous (IO) injection of 10mg of morphine mixed with up to 100mg of saline into the tibial tubercle. The control group will receive the standard of care treatment, which is no IO injection. The subjects' post-operative pain levels, pain medication consumption, side effects to pain medications, and range of motion will be recorded for 14 days following surgery. Additionally, patient reported outcomes will be tracked via surveys prior to surgery and 2, 6, and 12-weeks following surgery.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Methodist Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert A. Jack, The Methodist Hospital Research Institute
- Investigators
- Robert Jack, MD, Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06511232
- Sponsor's protocol ID
- PRO00037918
- Status last verified
- Apr 2026
- First submitted
- 2 Jul 2024
- Last updated
- 9 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraosseous Morphine Administration During Anterior Cruciate Ligament Reconstruction: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06511232
- Acronym / sponsor ID
- PRO00037918
- Conditions
- Anterior Cruciate Ligament Tear, Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- The Methodist Hospital Research InstituteUniversity, hospital or other
- Study start
- 19 Aug 2024 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 19 Jul 2024 (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.
The purpose of this study is to determine if intraosseous (IO) morphine decreases pain and post-operative opioid use in patients undergoing anterior cruciate ligament (ACL) reconstruction.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study is a single-blind randomized controlled trial with two arms, 1) Intervention and 2) control. The intervention group will receive an intraosseous (IO) injection of 10mg of morphine mixed with up to 100mg of saline into the tibial tubercle. The control group will receive the standard of care treatment, which is no IO injection. The subjects' post-operative pain levels, pain medication consumption, side effects to pain medications, and range of motion will be recorded for 14 days following surgery. Additionally, patient reported outcomes will be tracked via surveys prior to surgery and 2, 6, and 12-weeks following surgery.
| Arm | Type | Receives |
|---|---|---|
| Intraosseous Injection of Morphine | Experimental | Drug: Intraosseous MorphineThe intervention group will receive an intraosseous (IO) injection of 10mg of morphine mixed with up to 100mg of saline into the tibial tubercle during a standard ACL reconstruction. |
| Standard of Care Morphine Administration | No intervention | –The control group will receive the standard of care treatment, which is no IO injection during a standard ACL reconstruction. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients of the IRB approved surgeon(s) undergoing ACL reconstruction with bone-to-bone (BTB) autograft
- Patients aged between 18-40 years old at the time of surgery
Key exclusion criteria (10 listed)
- Patients undergoing ACL reconstruction with any other type of autograft or allograft other than BTB
- Patients younger than 18 years old or older than 40 years old
- Patients undergoing meniscal root repair or any other repair that changes their weight-bearing status
- Patients with a history of substance abuse
- Vulnerable populations
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 |
|---|---|---|
| Intraosseous MorphineAlso: Duramorph, Astramorph PF, InfumorphMore recently, intraosseous infusion of analgesics and antibiotics has gained traction in the total joint arthroplasty literature. In knee arthroplasty patients, the combination of a spine and adductor canal block with an intraosseous infusion of morphine into the tibial tubercle prior to incision yielded lower pain in the immediate postoperative period and at 2 weeks, less pain medication use, and significantly better patient-reported outcomes while also reducing systemic opioid exposure in the early postoperative period compared to the spine and adductor block alone.3 No study to date in the available literature has evaluated the efficacy of intraosseous morphine infusion in managing acute postoperative pain in patients undergoing ACL reconstruction with bone-patellar tendon-bone autograft, so that is the intended evaluation point with this project. | Drug | Intraosseous Injection of Morphine |
Primary outcome
Patient Pain Levels in the Post-Operative Period as assessed by a patient-reported post operative symptom journal.
Time frame: 2 weeks postop, 6 weeks postop, 12 weeks postop
The study will measure patient-reported levels of pain on a daily basis (for a total of two weeks) with a symptom journal, which will ask patients to report on a variety of pain-related outcomes including levels of pain throughout different times of day, levels of nausea throughout different times of the day, and what pain medication(s) they are taking and at what time.
Changes in Post-Operative Opioid Use
Time frame: 2 weeks postop
To examine if the use of IO morphine will result in different levels of post-operative opioid use compared to SOC administration of morphine. This outcome will be assessed utilizing the daily symptom journal which will ask patients to complete daily logs of the pain medication that they take (what kind, what dose, when they took it, etc.) for two weeks following their operation.
Patient Pain Levels in the Post-Operative Period as assessed by the Lysholm Knee Survey
Time frame: 2 weeks postop, 6 weeks postop, 12 weeks postop
Participants will be asked to complete the Lysholm Knee survey at 2, 6, and 12 weeks postop which will assess patient progress following surgery such as pain, swelling, climbing stairs, using a crutch, etc. The Lysholm scale consists of eight items with each question response being assigned an arbitrary score on an increasing scale. The total score is the sum of each response to the eight questions and may range from 0-100 where higher scores indicate a better outcome with fewer symptoms or disability.
3 secondary outcomes
Patient Range of Motion in the Post-Operative Period as assessed by the KOOS, JR Knee Survey
Time frame: Preop, 2 weeks postop, 6 weeks postop, 12 weeks postop
Patient Activity Level in the Post-Operative Period as assessed by the Tegner scale.
Time frame: Preop, 2 weeks postop, 6 weeks postop, 12 weeks postop
Patient Range of Motion in the Post-Operative Period as assessed by the Lysholm Knee Survey
Time frame: 2 weeks postop, 6 weeks postop, 12 weeks postop
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 9 Apr 2026.
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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.
Robert Jack, MD principal investigator
The Methodist Hospital Research Institute
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 Intraosseous Morphine in people with Anterior Cruciate Ligament Tear and Anterior Cruciate Ligament Injuries, run by The Methodist Hospital Research Institute 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 2 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 9 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.
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?
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 Haley Goble, MHA (713-441-3930, hmgoble@houstonmethodist.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Pain Levels in the Post-Operative Period as assessed by a patient-reported post operative symptom journal. (time frame: 2 weeks postop, 6 weeks postop, 12 weeks postop). The study lists 3 primary outcomes in all. 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 9 Apr 2026.