ACL TearNCT04360928
Knee Split Comparison After ACL Reconstruction
A study testing Graymont X ERIS Knee Splint and Standard Hinge Knee Brace in people with ACL Tear and Arthrofibrosis, run by Rush University Medical Center at 1 site in United States.
Trial summary
This study will evaluate the efficacy of the Graymont X ERIS Knee Splint brace in the postoperative period of ACL reconstruction to improve range of motion, specifically the achievement of terminal extension and time-to-achievement compared to the standard hinged knee brace. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- ACL Tear, Arthrofibrosis, ACL Injury
- What is being tested?
- Graymont X ERIS Knee Splint and Standard Hinge Knee Brace
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2023to 6 Jan 2025
- 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Primary ACL Reconstruction
- No associated repair or reconstruction procedures (meniscal repair, other ligamentous pathology). Patients undergoing concurrent partial meniscectomy would be eligible for inclusion.
- Clinical and radiographic examination (MRI), performed as standard of care prior to study enrollment, consistent with an acute full thickness ACL tear and surgical consent for ACL reconstruction with a patellar tendon autograft
- Written and informed consent for study participation
Who cannot join
- Patients younger than 18 or older than 40 years of age
- Revision surgery or prior history of knee surgery
- Concomitant ligamentous, meniscal, or cartilage injury that would alter postoperative weight bearing status or rehabilitation protocol
- Inability to comply with the proposed follow-up clinic visits
- Patients lacking decisional capacity
- Pregnant or breast-feeding women
Show all 9Show fewer
- Worker's compensation patients
- Any clinically significant finding that would place the patient at health risk, impact the study, or affect the completion of the study
- Any psychiatric illness that would prevent comprehension of the details and nature of the study and interfere with follow-up clinic visits
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
Official title: Postoperative ERIS Knee Splinting Following ACLR: A Randomized Clinical Trial
This study will evaluate the efficacy of the Graymont X ERIS Knee Splint brace in the postoperative period of ACL reconstruction to improve range of motion, specifically the achievement of terminal extension and time-to-achievement compared to the standard hinged knee brace. This will be directly measured with goniometric angle and heel-height measurements relative to the contralateral side. Other metrics will include standard, validated patient reported outcomes and requirements for additional interventions to treat extension deficits including, but not limited to, additional therapy, intraarticular injections, oral corticosteroids, manipulation under anesthesia, or arthroscopic arthrolysis.
Read the detailed description
This study will be a prospective randomized controlled trial of patients undergoing arthroscopic reconstruction of full thickness ACL tears with bone-patellar tendon-bone autograft. All patients who sign the consent form will be enrolled in the study and randomized to one of the two treatment arms.
Subjects will be appropriately fitted for the brace corresponding to randomization on the day of surgery. All braces will be placed on the subject in the operating room at the conclusion of the procedure. All patient will begin a standardized physical therapy protocol on postoperative day 1-14.
Follow-up will take place at standard of care office visits at 1-week, 2-week, 6-weeks, 12-weeks, and 6-months. Range of motion, including goniometric angle and heel-height measurements, will be recorded at all postoperative time points. Time-to-achievement of full symmetric extension relative to the non-surgical knee will be monitored and recorded. At 3, 6, and 12 months, patients will also be asked to complete standardized, patient-reported outcomes questionnaires including IKDC, KOOS, PROMIS, VAS pain, VR/SF 12, and brief resilience scale. Patients will also be asked to answer questions regarding return to work and return to sport throughout the 1-year postoperative period.
Both treatment groups will progress according to standardized, postoperative rehabilitation programs, similar to the program outlined below.
Phase I: Protection, Range of Motion (ROM), and Proprioception
Goal:
- To protect the surgical graft, restore lower extremity mobility, and proprioception
Precautions:
- Patient can initiate immediate weight bearing with knee immobilizer brace locked at 0º extension.
- Patients may unlock or remove brace once they are able to perform a straight leg raise without any quadriceps lag and perform a single leg stance (SLS) on surgical limb for at least 30 seconds. Patients must also wear the brace with any weight bearing activity for six weeks.
Criteria for progression to next phase:
- Non-antalgic gait with no observable gait impairments
- ROM: Goal of extension to at least 0º, and flexion within 10º of contralateral knee.
- Perform single leg stance on surgical limb on dynamic surfaces (balance board, foam, etc.)
Exercises to be included:
ROM:
- Flexion: heel slides, wall slides, prone hamstring curls
- Extension: supine or prone hangs, hamstring and calf stretching
NWB strengthening:
- Quadriceps sets (prone and supine), leg raises, and bridges on a swiss ball
Proprioception:
- SLS from static to dynamic surfaces and movements, 3-way lunges, balance board, rebounder or therapist ball tossing
Phase II: Strength and Endurance
Goal:
- Build single limb endurance and to prepare for agility training
Precautions:
- No running/jogging or jumping.
Criteria for progression to next phase:
- Full, pain free knee AROM within 3º of contralateral knee
- Able to perform single leg squat to approximately 60º knee flexion for 2 minutes without joint pain or compensations
- No compensatory gait patterns during faster ambulation speeds
Exercises to be included:
ROM:
- Stretching as needed (calf, hamstring, quad, trunk, upper body)
NWB:
- Trunk/core dynamics
Proprioception:
- Single leg stance with trunk rotations (use resistance for progression), floor touches, cone pick-ups on stable and unstable surfaces
Phase III: Power and Agility
Goal:
- Gain type II, fast twitch muscle fibers and prepare for return to sport training
Precautions:
- Not to be initiated until at least 12 weeks post-operatively
- No uncontrolled jumping (i.e. on grass, when not supervised by medical staff)
- No cutting or pivoting at full speeds
Criteria for progression to next phase:
- Perform single leg squat to approximately 60º knee flexion for 3 minutes against external resistance
- Perform lateral and diagonal jumping of a distance equal to the patient's leg length or greater for 2 minutes or longer
- Perform double leg jumps from at least. a 12-inch surface
- Perform single leg static jumps from flat surface
Exercises to be included:
Leg press, lunge, hamstring curl
Agility:
- Ladder training, cone drills, lateral and diagonal jumping adding external resistance
Phase IV: Return to Sport Training
Precautions:
- No physical contact during sport specific training
- No live sport performance until cleared by functional sports assessment and surgeon
Patients will undergo standard of care physical therapy 2-3 times per week for 20 weeks as directed by their physician. Physical therapy will begin as directed by physician generally before post op day 14.
- Conditions
- ACL Tear, Arthrofibrosis, ACL Injury
- Being tested
- Graymont X ERIS Knee Splint, Standard Hinge Knee Brace
- 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.
Graymont X ERIS Knee SplintDevice
Specific type of splint which utilizes an inflatable air pocket on the posterior aspect of the leg to provide a combination of bracing and splinting in full extension in the immediate postoperative period.
Standard Hinge Knee BraceDevice
Standard knee brace used postoperatively after ACL reconstruction.
| Study group | Role | What they receive |
|---|---|---|
| Graymont X ERIS Knee Splint Degree Splinting Group | Experimental | These patients will be randomized to receive the Graymont X ERIS Knee Splint. Patients will follow the same standardized postoperative rehabilitation protocol. Receives: Device: Graymont X ERIS Knee Splint |
| Standard Hinged Knee Brace | Sham comparator | These patients will be randomized to receive a standard hinged knee brace. Patients will follow the same standardized postoperative rehabilitation protocol. Receives: Device: Standard Hinge Knee Brace |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to full symmetric extension
Time-to-achievement of full symmetric extension relative to the non-surgical knee
Measured: Up to 6 months postoperatively
Range of motion
Includes heel-height measurements
Measured: 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start1 Aug 2023
- Primary completion1 Jan 2025
- Study completion6 Jan 2025
Why it stopped: Recruitment goals not met
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACL TearStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04360928
- Sponsor's protocol ID
- 20030401
- Status last verified
- Jan 2025
- First submitted
- 6 Mar 2020
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share IPD to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative ERIS Knee Splinting Following ACLR: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04360928
- Acronym / sponsor ID
- 20030401
- Conditions
- ACL Tear, Arthrofibrosis, ACL Injury
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment goals not met
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 6 Jan 2025 (actual)
- First posted
- 24 Apr 2020 (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.
This study will evaluate the efficacy of the Graymont X ERIS Knee Splint brace in the postoperative period of ACL reconstruction to improve range of motion, specifically the achievement of terminal extension and time-to-achievement compared to the standard hinged knee brace. This will be directly measured with goniometric angle and heel-height measurements relative to the contralateral side. Other metrics will include standard, validated patient reported outcomes and requirements for additional interventions to treat extension deficits including, but not limited to, additional therapy, intraarticular injections, oral corticosteroids, manipulation under anesthesia, or arthroscopic arthrolysis.
Detailed description
This study will be a prospective randomized controlled trial of patients undergoing arthroscopic reconstruction of full thickness ACL tears with bone-patellar tendon-bone autograft. All patients who sign the consent form will be enrolled in the study and randomized to one of the two treatment arms.
Subjects will be appropriately fitted for the brace corresponding to randomization on the day of surgery. All braces will be placed on the subject in the operating room at the conclusion of the procedure. All patient will begin a standardized physical therapy protocol on postoperative day 1-14.
Follow-up will take place at standard of care office visits at 1-week, 2-week, 6-weeks, 12-weeks, and 6-months. Range of motion, including goniometric angle and heel-height measurements, will be recorded at all postoperative time points. Time-to-achievement of full symmetric extension relative to the non-surgical knee will be monitored and recorded. At 3, 6, and 12 months, patients will also be asked to complete standardized, patient-reported outcomes questionnaires including IKDC, KOOS, PROMIS, VAS pain, VR/SF 12, and brief resilience scale. Patients will also be asked to answer questions regarding return to work and return to sport throughout the 1-year postoperative period.
Both treatment groups will progress according to standardized, postoperative rehabilitation programs, similar to the program outlined below.
Phase I: Protection, Range of Motion (ROM), and Proprioception
Goal:
- To protect the surgical graft, restore lower extremity mobility, and proprioception
Precautions:
- Patient can initiate immediate weight bearing with knee immobilizer brace locked at 0º extension.
- Patients may unlock or remove brace once they are able to perform a straight leg raise without any quadriceps lag and perform a single leg stance (SLS) on surgical limb for at least 30 seconds. Patients must also wear the brace with any weight bearing activity for six weeks.
Criteria for progression to next phase:
- Non-antalgic gait with no observable gait impairments
- ROM: Goal of extension to at least 0º, and flexion within 10º of contralateral knee.
- Perform single leg stance on surgical limb on dynamic surfaces (balance board, foam, etc.)
Exercises to be included:
ROM:
- Flexion: heel slides, wall slides, prone hamstring curls
- Extension: supine or prone hangs, hamstring and calf stretching
NWB strengthening:
- Quadriceps sets (prone and supine), leg raises, and bridges on a swiss ball
Proprioception:
- SLS from static to dynamic surfaces and movements, 3-way lunges, balance board, rebounder or therapist ball tossing
Phase II: Strength and Endurance
Goal:
- Build single limb endurance and to prepare for agility training
Precautions:
- No running/jogging or jumping.
Criteria for progression to next phase:
- Full, pain free knee AROM within 3º of contralateral knee
- Able to perform single leg squat to approximately 60º knee flexion for 2 minutes without joint pain or compensations
- No compensatory gait patterns during faster ambulation speeds
Exercises to be included:
ROM:
- Stretching as needed (calf, hamstring, quad, trunk, upper body)
NWB:
- Trunk/core dynamics
Proprioception:
- Single leg stance with trunk rotations (use resistance for progression), floor touches, cone pick-ups on stable and unstable surfaces
Phase III: Power and Agility
Goal:
- Gain type II, fast twitch muscle fibers and prepare for return to sport training
Precautions:
- Not to be initiated until at least 12 weeks post-operatively
- No uncontrolled jumping (i.e. on grass, when not supervised by medical staff)
- No cutting or pivoting at full speeds
Criteria for progression to next phase:
- Perform single leg squat to approximately 60º knee flexion for 3 minutes against external resistance
- Perform lateral and diagonal jumping of a distance equal to the patient's leg length or greater for 2 minutes or longer
- Perform double leg jumps from at least. a 12-inch surface
- Perform single leg static jumps from flat surface
Exercises to be included:
Leg press, lunge, hamstring curl
Agility:
- Ladder training, cone drills, lateral and diagonal jumping adding external resistance
Phase IV: Return to Sport Training
Precautions:
- No physical contact during sport specific training
- No live sport performance until cleared by functional sports assessment and surgeon
Patients will undergo standard of care physical therapy 2-3 times per week for 20 weeks as directed by their physician. Physical therapy will begin as directed by physician generally before post op day 14.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Graymont X ERIS Knee Splint Degree Splinting Group | Experimental | Device: Graymont X ERIS Knee SplintThese patients will be randomized to receive the Graymont X ERIS Knee Splint. Patients will follow the same standardized postoperative rehabilitation protocol. |
| Standard Hinged Knee Brace | Sham comparator | Device: Standard Hinge Knee BraceThese patients will be randomized to receive a standard hinged knee brace. Patients will follow the same standardized postoperative rehabilitation protocol. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Primary ACL Reconstruction
- No associated repair or reconstruction procedures (meniscal repair, other ligamentous pathology). Patients undergoing concurrent partial meniscectomy would be eligible for inclusion.
- Clinical and radiographic examination (MRI), performed as standard of care prior to study enrollment, consistent with an acute full thickness ACL tear and surgical consent for ACL reconstruction with a patellar tendon autograft
- Written and informed consent for study participation
Key exclusion criteria (9 listed)
- Patients younger than 18 or older than 40 years of age
- Revision surgery or prior history of knee surgery
- Concomitant ligamentous, meniscal, or cartilage injury that would alter postoperative weight bearing status or rehabilitation protocol
- Inability to comply with the proposed follow-up clinic visits
- Patients lacking decisional capacity
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 |
|---|---|---|
| Graymont X ERIS Knee SplintSpecific type of splint which utilizes an inflatable air pocket on the posterior aspect of the leg to provide a combination of bracing and splinting in full extension in the immediate postoperative period. | Device | Graymont X ERIS Knee Splint Degree Splinting Group |
| Standard Hinge Knee BraceStandard knee brace used postoperatively after ACL reconstruction. | Device | Standard Hinged Knee Brace |
Primary outcome
Time to full symmetric extension
Time frame: Up to 6 months postoperatively
Time-to-achievement of full symmetric extension relative to the non-surgical knee
Range of motion
Time frame: 6 months postoperatively
Includes heel-height measurements
Results and safety
The study was stopped early (reason given: Recruitment goals not met). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
- Individual participant dataSharing planned: No. No plan to share IPD to other researchers.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Graymont X ERIS Knee Splint and Standard Hinge Knee Brace in people with ACL Tear and Arthrofibrosis, run by Rush University Medical Center 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 4 inclusion and 9 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: stopped early, as of the sponsor's last update on 9 Jan 2025. 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. Some participants in this study may receive a placebo. 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?
The study was stopped early (reason given: Recruitment goals not met). Results are not available in the source record.
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?
Time to full symmetric extension (time frame: Up to 6 months postoperatively). The study lists 2 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 Jan 2025.