Anterior Cruciate Ligament InjuryPhase 4FNB vs ACBNCT03704376

Clinical Comparison of Femoral Nerve Versus Adductor Canal Block Following Anterior Ligament Reconstruction

A Phase 4 study testing 30 ml of 0.2% ropivacaine, 15 ml of 0.2% ropivacaine and 100 mcg clonidine in people with Anterior Cruciate Ligament Injury, run by The University of Texas Health Science Center, Houston at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This study will examine the potential differences between femoral nerve blockade (FNB) and adductor canal blockade (ACB) for pain control and quadriceps muscle activation for patients following anterior cruciate ligament (ACL) reconstruction. Read more about this study

Who is it for?: Ages 16 to 30 years
Conditions the study is for: Anterior Cruciate Ligament Injury
What is being tested?: 30 ml of 0.2% ropivacaine, 15 ml of 0.2% ropivacaine and 100 mcg clonidine
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 125 participants
Where: 1 siteUnited States
Study dates: 1 Feb 2016to 16 Nov 2017
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 30 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Males \& Females ages 16-30 yrs
Undergoing ACL reconstruction by Co-Investigator (Walter Lowe)
Receiving peri-operative FNB or ACB

Who cannot join

Not enrolled within the COFAKS study
Receiving intrathecal nerve blockade or no blockade

Trial locations and contacts

1 site in 1 country.

United States1 site

The University of Texas Health Science Center-Houston
Houston, Texas, 77030

Other trials in United States

About this study

Official title: Clinical Outcome Following Arthroscopic Knee Surgery (COFAKS)-Addendum

Read the detailed description

Adequate pain control following anterior cruciate ligament reconstruction (ACL) often requires a regional nerve block. The femoral nerve block (FNB) has been traditionally employed. More recently, ultrasound application to regional nerve blocks allows for the use of alternatives such as the adductor canal block following ACL reconstruction. In 2009, Manickam et al. were the first to describe the ultrasound guided adductor canal technique for the purposes of knee joint analgesia. Unlike other traditional techniques that seek to cause a sensory as well as a motor blockade, the adductor canal block attempts to spare the motor block of the neighboring distributions in an attempt to offer selective analgesia and strength preservation. Chisholm et al demonstrated the adductor canal block provides similar and adequate postoperative analgesia when compared to the FNB, following arthroscopic ACL reconstruction with patellar tendon autograft. Their study focused on analgesia and did not evaluate quadriceps function or impact on rehabilitation. Sharma et al drew the first association between femoral nerve blocks and increased fall risk due to muscle weakness in total knee arthroplasty population. A randomized, blinded study to compare quadriceps strength following adductor canal versus FNB was performed by Kwofie et al. They showed that compared with FNB, adductor canal block results in significant quadriceps motor sparing and significantly preserved balance. These studies focused on acute muscle weakness after regional anesthesia and its relation to safety. Quadriceps function is very important in rehabilitation of ACL reconstruction. Luo et al demonstrated long term deficits related to FNB. They demonstrated that patients treated with FNB after ACL reconstruction had significant isokinetic deficits in knee extension and flexion strength at 6 months when compared with patients who did not receive a nerve block. Patients without a block were 4 times more likely to meet criteria for clearance to return to sports at 6 months. In addition, Krych et al found significantly inferior quadriceps strength and function at 6 months in FNB group. Based on the available literature, we aim to compare femoral nerve versus adductor canal block in regards to pain control and muscle strength in ACL reconstruction patients until return to sport.

Conditions: Anterior Cruciate Ligament Injury
Being tested: 30 ml of 0.2% ropivacaine, 15 ml of 0.2% ropivacaine, 100 mcg clonidine, High-frequency linear ultrasound transducer
Keywords: Femoral Nerve Block, Adductor Canal Block
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.

30 ml of 0.2% ropivacaineDrug
15 ml of 0.2% ropivacaineDrug
100 mcg clonidineDrug
High-frequency linear ultrasound transducerDevice

Study groups in NCT03704376
Study group	Role	What they receive
Femoral Nerve Blockade	Active comparator	Ultrasound guided FNB (30 ml of 0.2% ropivacaine with 100 mcg clonidine using a 22-gauge 40 mm ProBloc II insulated needle; Kimberly-Clark, Roswell, Georgia) below the inguinal ligament using a high-frequency linear ultrasound transducer (4-12 Hz; Mindray M7; Mindray North America, Mahwah, NJ) with stimulator confirmation. Receives: Drug: 30 ml of 0.2% ropivacaine; Drug: 100 mcg clonidine; Device: High-frequency linear ultrasound transducer
Adductor Canal Blockade	Active comparator	Ultrasound guided ACB (15 ml of 0.2% ropivacaine with 100 mcg clonidine using a 22-gauge 40 mm ProBloc II insulated needle; Kimberly-Clark, Roswell, Georgia) at the mid-thigh using a high-frequency linear ultrasound transducer (4-12 Hz; Mindray M7; Mindray North America, Mahwah, NJ). Receives: Drug: 15 ml of 0.2% ropivacaine; Drug: 100 mcg clonidine; Device: High-frequency linear ultrasound transducer

What is being measured

The primary outcome is the main question the study is designed to answer.

Quadriceps Muscle Activation as Assessed by Surface Electromyography (sEMG)
Quadriceps muscle activation was examined using surface electromyography (sEMG) of the vastus medialis oblique muscle. Peak sEMG activity was recorded in microvolts (uV) on the surgical and contralateral limbs while performing five maximal effort isometric contractions in full knee extension--the reported values are equal to the quadriceps sEMG in uV of the contralateral limb minus the quadriceps sEMG in uV of the surgical limb.
Measured: Post-operative day 1
Quadriceps Muscle Activation as Assessed by Surface Electromyography (EMG)
Quadriceps muscle activation was examined using surface electromyography (sEMG) of the vastus medialis oblique muscle. Peak sEMG activity was recorded in microvolts (uV) on the surgical and contralateral limbs while performing five maximal effort isometric contractions in full knee extension--the reported values are equal to the quadriceps sEMG in uV of the contralateral limb minus the quadriceps sEMG in uV of the surgical limb.
Measured: Post-operative day 14
Quadriceps Muscle Activation as Assessed by Surface Electromyography (EMG)
Quadriceps muscle activation was examined using surface electromyography (sEMG) of the vastus medialis oblique muscle. Peak sEMG activity was recorded in microvolts (uV) on the surgical and contralateral limbs while performing five maximal effort isometric contractions in full knee extension--the reported values are equal to the quadriceps sEMG in uV of the contralateral limb minus the quadriceps sEMG in uV of the surgical limb.
Measured: 4 weeks post operative

Secondary outcomes (17)

Number of Successful Repetitions With Straight Leg Raise Test
The straight leg raise assessment was performed in a standardized long-sitting position with well-knee flexed to 90 degrees. Patients were asked to complete 30 repetitions of straight leg raises with a small bolster supporting the heel using the following criteria; (1) perform with no visible quad lag (2) reach the height of the opposite tibial tubercle and (3) maintain a controlled rate of 30 hertz for the ascending and descending phases. The examination was only performed on the surgical limb and the absolute number of successful repetitions is reported.
Measured: Post-operative day 1
Number of Successful Repetitions With Straight Leg Raise Test
The straight leg raise assessment was performed in a standardized long-sitting position with well-knee flexed to 90 degrees. Patients were asked to complete 30 repetitions of straight leg raises with a small bolster supporting the heel using the following criteria; (1) perform with no visible quad lag (2) reach the height of the opposite tibial tubercle and (3) maintain a controlled rate of 30 hertz for the ascending and descending phases. The examination was only performed on the surgical limb and the absolute number of successful repetitions is reported.
Measured: Post-operative day 14
Number of Successful Repetitions With Straight Leg Raise Test
The straight leg raise assessment was performed in a standardized long-sitting position with well-knee flexed to 90 degrees. Patients were asked to complete 30 repetitions of straight leg raises with a small bolster supporting the heel using the following criteria; (1) perform with no visible quad lag (2) reach the height of the opposite tibial tubercle and (3) maintain a controlled rate of 30 hertz for the ascending and descending phases. The examination was only performed on the surgical limb and the absolute number of successful repetitions is reported.
Measured: 4 weeks post operative
Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
The items are scored on a visual analogical scale from 0-10, 0 being the better outcome.
Measured: 1 hr post surgery
Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
The items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.
Measured: 2 hr post surgery
Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
The items are scored on a visual analogical scale from 0-10, with 0 being the better
Measured: 3 hr post surgery
Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
The items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.
Measured: 4 hr post surgery
Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
The items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.
Measured: 5 hr post surgery
Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
The items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.
Measured: 6 hr post surgery
Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
The items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.
Measured: 7 hr post surgery
Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
The items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.
Measured: 8 hr post surgery
Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
The items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.
Measured: 9 hr post surgery
Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
The items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.
Measured: 10 hr post surgery
Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
The items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.
Measured: 11 hr post surgery
Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
The items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.
Measured: 12 hr post surgery
Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
The items are scored on a visual analogical scale from 0-10, with 0 being the better
Measured: Postoperative physicians visit
Narcotics Use as Assessed by Morphine Equivalents Consumed
morphine equivalents consumed during the entire post-anesthesia care unit (PACU) visit post surgery will be obtained from the All-scripts electronic medical record (EMR) system.
Measured: Entire post-anesthesia care unit (PACU) visit post surgery, PACU range 1 hr to 12 hrs post surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 201616 Nov 2017

First posted12 Oct 2018
Study start1 Feb 2016
Primary completion16 Nov 2017
Study completion16 Nov 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Anterior Cruciate Ligament InjuryStudies of the same condition, open and under way.
More trials run by The University of Texas Health Science Center, HoustonThe 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 125 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03704376
Sponsor's protocol ID: HSC-MH-14-0734 (addendum)
Acronym: FNB vs ACB
Status last verified: Sep 2021
First submitted: 27 Sep 2018
Last updated: 21 Oct 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Duncan BR, Reid M, Kleihege J, Higbie S, Gardner EP, Lowe W, Bailey L. Comparison of Psychological Readiness to Return to Sport After Primary Versus Revision Anterior Cruciate Ligament Reconstruction. Orthop J Sports Med. 2023 May 2;11(5):23259671231159408. doi: 10.1177/23259671231159408. eCollection 2023 May.
PubMed 37152546
Galloway C, Ward H, Higbie S, Kleihege J, Kumaravel M, Lowe WR, Bailey L. Relationship Between Bone Bruise Volume and Patient Outcomes After ACL Reconstruction. Orthop J Sports Med. 2023 Feb 24;11(2):23259671221146205. doi: 10.1177/23259671221146205. eCollection 2023 Feb.
PubMed 36860772
Bailey L, Weldon M, Kleihege J, Lauck K, Syed M, Mascarenhas R, Lowe WR. Platelet-Rich Plasma Augmentation of Meniscal Repair in the Setting of Anterior Cruciate Ligament Reconstruction. Am J Sports Med. 2021 Oct;49(12):3287-3292. doi: 10.1177/03635465211036471. Epub 2021 Sep 3.
PubMed 34477016
Worsham J, Lowe WR, Copa D, Williams S, Kleihege J, Lauck K, Mascarenhas R, Bailey L. Subsequent Surgery for Loss of Motion After Anterior Cruciate Ligament Reconstruction Does Not Influence Function at 2 Years: A Matched Case-Control Analysis. Am J Sports Med. 2019 Sep;47(11):2550-2556. doi: 10.1177/0363546519863347. Epub 2019 Jul 26.
PubMed 31348866
Bailey L, Griffin J, Elliott M, Wu J, Papavasiliou T, Harner C, Lowe W. Adductor Canal Nerve Versus Femoral Nerve Blockade for Pain Control and Quadriceps Function Following Anterior Cruciate Ligament Reconstruction With Patellar Tendon Autograft: A Prospective Randomized Trial. Arthroscopy. 2019 Mar;35(3):921-929. doi: 10.1016/j.arthro.2018.10.149. Epub 2019 Feb 4.
PubMed 30733025

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
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Recruiting
Graded Exposure and Mindfulness Meditation for Patients Post-ACL Reconstruction
Anterior Cruciate Ligament Injuries
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Clinical and Biological Outcomes of BioBrace-Augmented ACL Reconstruction
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Not yet recruiting
Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Recovery Quality in Patients Undergoing Anterior Cruciate Ligament Reconstruction
Anterior Cruciate Ligament Injuries, Recovery Quality

All Anterior Cruciate Ligament Injury trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Outcome Following Arthroscopic Knee Surgery (COFAKS)-Addendum
ClinicalTrials.gov ID: NCT03704376
Acronym / sponsor ID: FNB vs ACB / HSC-MH-14-0734 (addendum)
Conditions: Anterior Cruciate Ligament Injury
Keywords: Femoral Nerve Block, Adductor Canal Block
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 125 participants (actual)
Lead sponsor: The University of Texas Health Science Center, HoustonUniversity, hospital or other
Collaborators: Memorial Hermann Hospital
Study start: 1 Feb 2016 (actual)
Primary completion: 16 Nov 2017 (actual)
Study completion: 16 Nov 2017 (actual)
First posted: 12 Oct 2018 (actual)
Results: Posted 11 Dec 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Femoral Nerve Blockade	Active comparator	Drug: 30 ml of 0.2% ropivacaine, Drug: 100 mcg clonidine, Device: High-frequency linear ultrasound transducerUltrasound guided FNB (30 ml of 0.2% ropivacaine with 100 mcg clonidine using a 22-gauge 40 mm ProBloc II insulated needle; Kimberly-Clark, Roswell, Georgia) below the inguinal ligament using a high-frequency linear ultrasound transducer (4-12 Hz; Mindray M7; Mindray North America, Mahwah, NJ) with stimulator confirmation.
Adductor Canal Blockade	Active comparator	Drug: 15 ml of 0.2% ropivacaine, Drug: 100 mcg clonidine, Device: High-frequency linear ultrasound transducerUltrasound guided ACB (15 ml of 0.2% ropivacaine with 100 mcg clonidine using a 22-gauge 40 mm ProBloc II insulated needle; Kimberly-Clark, Roswell, Georgia) at the mid-thigh using a high-frequency linear ultrasound transducer (4-12 Hz; Mindray M7; Mindray North America, Mahwah, NJ).

Who may qualify

Ages: 16 to 30 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (3 listed)

Males \& Females ages 16-30 yrs
Undergoing ACL reconstruction by Co-Investigator (Walter Lowe)
Receiving peri-operative FNB or ACB

Key exclusion criteria (2 listed)

Not enrolled within the COFAKS study
Receiving intrathecal nerve blockade or no blockade

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
30 ml of 0.2% ropivacaine	Drug	Femoral Nerve Blockade
15 ml of 0.2% ropivacaine	Drug	Adductor Canal Blockade
100 mcg clonidine	Drug	Adductor Canal Blockade, Femoral Nerve Blockade
High-frequency linear ultrasound transducer	Device	Adductor Canal Blockade, Femoral Nerve Blockade

Primary outcome

Quadriceps Muscle Activation as Assessed by Surface Electromyography (sEMG)
Time frame: Post-operative day 1
Quadriceps muscle activation was examined using surface electromyography (sEMG) of the vastus medialis oblique muscle. Peak sEMG activity was recorded in microvolts (uV) on the surgical and contralateral limbs while performing five maximal effort isometric contractions in full knee extension--the reported values are equal to the quadriceps sEMG in uV of the contralateral limb minus the quadriceps sEMG in uV of the surgical limb.
Quadriceps Muscle Activation as Assessed by Surface Electromyography (EMG)
Time frame: Post-operative day 14
Quadriceps muscle activation was examined using surface electromyography (sEMG) of the vastus medialis oblique muscle. Peak sEMG activity was recorded in microvolts (uV) on the surgical and contralateral limbs while performing five maximal effort isometric contractions in full knee extension--the reported values are equal to the quadriceps sEMG in uV of the contralateral limb minus the quadriceps sEMG in uV of the surgical limb.
Quadriceps Muscle Activation as Assessed by Surface Electromyography (EMG)
Time frame: 4 weeks post operative
Quadriceps muscle activation was examined using surface electromyography (sEMG) of the vastus medialis oblique muscle. Peak sEMG activity was recorded in microvolts (uV) on the surgical and contralateral limbs while performing five maximal effort isometric contractions in full knee extension--the reported values are equal to the quadriceps sEMG in uV of the contralateral limb minus the quadriceps sEMG in uV of the surgical limb.

17 secondary outcomes

Number of Successful Repetitions With Straight Leg Raise Test
Time frame: Post-operative day 1
Number of Successful Repetitions With Straight Leg Raise Test
Time frame: Post-operative day 14
Number of Successful Repetitions With Straight Leg Raise Test
Time frame: 4 weeks post operative
Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
Time frame: 1 hr post surgery
Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
Time frame: 2 hr post surgery
Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
Time frame: 3 hr post surgery
Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
Time frame: 4 hr post surgery
Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
Time frame: 5 hr post surgery
Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
Time frame: 6 hr post surgery
Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
Time frame: 7 hr post surgery
Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
Time frame: 8 hr post surgery
Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
Time frame: 9 hr post surgery
Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
Time frame: 10 hr post surgery
Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
Time frame: 11 hr post surgery
Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
Time frame: 12 hr post surgery
Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
Time frame: Postoperative physicians visit
Narcotics Use as Assessed by Morphine Equivalents Consumed
Time frame: Entire post-anesthesia care unit (PACU) visit post surgery, PACU range 1 hr to 12 hrs post surgery

Results and safety

Results posted to the registry on 11 Dec 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Femoral Nerve Blockade	42	38
Adductor Canal Blockade	44	40

Primary outcome: Quadriceps Muscle Activation as Assessed by Surface Electromyography (sEMG)

Time frame: Post-operative day 1. Mean (Standard Deviation). Unit: microvolts (uV)

Measure	Femoral Nerve Blockade n = 38	Adductor Canal Blockade n = 40
Value	266.5 (52.4)	212.5 (65.1)

Primary outcome: Quadriceps Muscle Activation as Assessed by Surface Electromyography (EMG)

Time frame: Post-operative day 14. Mean (Standard Deviation). Unit: microvolts (uV)

Measure	Femoral Nerve Blockade n = 38	Adductor Canal Blockade n = 40
Value	183.2 (41.8)	126.5 (48.9)

Primary outcome: Quadriceps Muscle Activation as Assessed by Surface Electromyography (EMG)

Time frame: 4 weeks post operative. Mean (Standard Deviation). Unit: microvolts (uV)

Measure	Femoral Nerve Blockade n = 38	Adductor Canal Blockade n = 40
Value	109.1 (32.2)	94.1 (33.2)

17 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Femoral Nerve Blockade	0 of 38 (0%)	16 of 38 (42.1%)	0 of 38
Adductor Canal Blockade	0 of 40 (0%)	11 of 40 (27.5%)	0 of 40

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37152546Duncan BR, Reid M, Kleihege J, Higbie S, Gardner EP, Lowe W, Bailey L. Comparison of Psychological Readiness to Return to Sport After Primary Versus Revision Anterior Cruciate Ligament Reconstruction. Orthop J Sports Med. 2023 May 2;11(5):23259671231159408. doi: 10.1177/23259671231159408. eCollection 2023 May.
Derived from this study: PubMed 36860772Galloway C, Ward H, Higbie S, Kleihege J, Kumaravel M, Lowe WR, Bailey L. Relationship Between Bone Bruise Volume and Patient Outcomes After ACL Reconstruction. Orthop J Sports Med. 2023 Feb 24;11(2):23259671221146205. doi: 10.1177/23259671221146205. eCollection 2023 Feb.
Derived from this study: PubMed 34477016Bailey L, Weldon M, Kleihege J, Lauck K, Syed M, Mascarenhas R, Lowe WR. Platelet-Rich Plasma Augmentation of Meniscal Repair in the Setting of Anterior Cruciate Ligament Reconstruction. Am J Sports Med. 2021 Oct;49(12):3287-3292. doi: 10.1177/03635465211036471. Epub 2021 Sep 3.
Derived from this study: PubMed 31348866Worsham J, Lowe WR, Copa D, Williams S, Kleihege J, Lauck K, Mascarenhas R, Bailey L. Subsequent Surgery for Loss of Motion After Anterior Cruciate Ligament Reconstruction Does Not Influence Function at 2 Years: A Matched Case-Control Analysis. Am J Sports Med. 2019 Sep;47(11):2550-2556. doi: 10.1177/0363546519863347. Epub 2019 Jul 26.
Derived from this study: PubMed 30733025Bailey L, Griffin J, Elliott M, Wu J, Papavasiliou T, Harner C, Lowe W. Adductor Canal Nerve Versus Femoral Nerve Blockade for Pain Control and Quadriceps Function Following Anterior Cruciate Ligament Reconstruction With Patellar Tendon Autograft: A Prospective Randomized Trial. Arthroscopy. 2019 Mar;35(3):921-929. doi: 10.1016/j.arthro.2018.10.149. Epub 2019 Feb 4.
Individual participant dataSharing planned: No

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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.

Lane Bailey, PhD, PT principal investigator

The University of Texas Health Science Center, Houston

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 2 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 21 Oct 2021. 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?

Yes. Results are posted in the registry (first posted 11 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Quadriceps Muscle Activation as Assessed by Surface Electromyography (sEMG) (time frame: Post-operative day 1). 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?

On the ClinicalTrials.gov record for NCT03704376, which also lists 5 linked publications.

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 21 Oct 2021.