Proximal Humeral FractureNCT06133920
Duration of Immobilization After Reverse Total Arthroplasty for Proximal Humerus Fractures
An observational study of Proximal Humeral Fracture and Reverse Total Shoulder Arthroplasty, run by Cooper Norcross Health at 1 site in United States.
Trial summary
The purpose of this study is to evaluate compare postoperative range of motion in patients who are given a sling for comfort only and allowed to start early active range of motion compared to patients who are placed in a sling for 4 weeks with passive range of motion only. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Proximal Humeral Fracture, Reverse Total Shoulder Arthroplasty
- What is being tested?
- Early Range of Motion and Immobilization
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2021to 1 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 60 years and older
- All sexes
- Adult, Older adult
Study population: Patients 60 years or older who have a displaced proximal humerus fracture that meet surgical criteria for a reverse total shoulder arthroplasty. Patients are not excluded based on sex
Who may be able to join
- Patients 60 years or older who have a displaced proximal humerus fracture
- Meets surgical criteria for a reverse total shoulder arthroplasty
- Receive surgical intervention within 6 weeks of initial injury
Who cannot join
- Patients <60 years in age
- Patients who cannot undergo surgery due to medical comorbidities
- Patients who receive surgical intervention after 6 weeks from initial injury
- Patients who have preoperative nerve damage from their fractures that would limit the ability to move the arm postoperatively
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
Cooper University Hospital
Camden, New Jersey, 08103
Pietro M Gentile, BA, (856) 968-7079, gentile-pietro@CooperHealth.edu
Catherine J Fedorka, MD, 856-968-7262, Fedorka-Catherine@CooperHealth.edu
About this study
Official title: Immobilization Versus Early Range of Motion in Reverse Total Arthroplasty in Patients With Proximal Humerus Fractures
The purpose of this study is to evaluate compare postoperative range of motion in patients who are given a sling for comfort only and allowed to start early active range of motion compared to patients who are placed in a sling for 4 weeks with passive range of motion only. Once enrolled, the patients will be randomized through computer randomization then placed in paper packets into either the immobilization group or the early range of motion group.
Read the detailed description
Reverse shoulder arthroplasty is often used for older patients with displaced proximal humerus fractures in the older patient population. Many surgeons have historically placed patients in a sling for 4-6 weeks after surgery to prevent dislocation or tuberosity displacement. More recently though, surgeons are becoming more lenient with these restrictions as they realize it is very difficult for an elderly patient to be immobilized for 4-6 weeks. There has been one randomized control trial looking at early range of motion versus immobilization for 6 weeks after a regular reverse total shoulder arthroplasty not done for fracture which showed no difference at one year. There have not been any studies to date looking at reverse total shoulder arthroplasty for fracture to see if there is any difference in range of motion at early or later time points and also if there is an increased risk of complications.
Preoperative visit/hospitalization: The patient will be identified as meeting inclusion criteria and the study will be explained to them. Patients will be given a consent form to review with adequate time to review and decide if they wish to participate. If they choose to participate, the patient will sign consent forms witnessed by personnel not associated with the study. Patients will be randomized once consent has been obtained.
The patient will then undergo surgery. Operative data will be collected from their chart including implants used, and intraoperative complications. They will be placed in a sling if they are randomized to the sling group and given instructions on passive range of motion exercises to start postoperative day one. If they are assigned to the early motion group they will be placed in a sling for comfort after surgery but told they can remove it when they feel their pain will allow. They will also be instructed on the same passive range of motion program as the sling group. This is different from the standard of care.
Once enrolled, the patients will be randomized through computer randomization then placed in paper packets into either the immobilization group or the early range of motion group.
They will undergo their reverse total shoulder arthroplasty for fracture as they will even if they do not agree to participate in the study (normal treatment)
The immobilization group will be placed in a shoulder abduction sling immediately after surgery for four weeks. They will be allowed to start gentle passive range of motion with forward flexion to 120 degrees, abduction to 90 degrees, and external rotation to 30 degrees. They will receive a home exercise program and formal physical therapy with these limits.
When they come out of the sling at four weeks they will start active range of motion and active assisted range of motion. They cannot internally rotate until 10 weeks after surgery. No formal strengthening until 3 months after surgery.
The early range of motion group will be given a sling for comfort after their surgery. They will be told they can use their arm as tolerated and can remove the sling when comfortable immediately after surgery. They will be allowed to start passive range of motion, active assisted range of motion, and gentle active range of motion with therapy as tolerated with the exception of no internal rotation. They will also not be allowed to strengthen until 12 weeks after surgery. They will get formal physical therapy and be given a home exercise program as well that will be directed by their physical therapist
Both groups will be evaluated postoperatively at 2 weeks, 6 weeks, 12 weeks, 6 months, 1 year, and two years. At each time point the following will be evaluated.
Visual analog pain score American Shoulder and Elbow Society Scores Range of motion Complications Radiographs will be obtained at these visits
Thereported outcome scores will either be recorded in the office or via email using the surgical outcomes system database that is already approved for use at Cooper via legal for quality outcome measures. The patient will be allowed to determine which method they would prefer and is easier for them.
All of these visits will be the same as patients who choose not to enroll in the study. No additional visits are required for the study. The only differences in treatment will be obtaining the patient outcome scores listed above and the random assignment to one of two treatment groups. The random treatment assignments are as follows; the first group of patients will be placed in a sling for four weeks but with early stretching through physical therapy, and the second group will be allowed to use the sling for comfort only and use their arm as tolerated for motion activities such as dressing and bathing. The second group will also receive physical therapy.
The results of the study will not be shared with the subjects or others unless they ask at the completion of the study at which point final data will be revealed to the subjects that ask.
- Being tested
- Early Range of Motion, Immobilization
- Keywords
- Proximal Humerus Fracture, Range of Motion, Immobilization
- Medical subject headings
- Shoulder Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Range of MotionOther
The early range of motion group will be given a sling for comfort after their surgery. They will be told they can use their arm as tolerated and can remove the sling when comfortable immediately after surgery. They will be allowed to start passive range of motion, active assisted range of motion, and gentle active range of motion with therapy as tolerated with the exception of no internal rotation. They will also not be allowed to strengthen until 12 weeks after surgery. They will get formal physical therapy and be given a home exercise program as well that will be directed by their physical therapist
ImmobilizationOther
The immobilization group will be placed in a shoulder abduction sling immediately after surgery for four weeks. They will be allowed to start gentle passive range of motion with forward flexion to 120 degrees, abduction to 90 degrees, and external rotation to 30 degrees. They will receive a home exercise program and formal physical therapy with these limits.
When they come out of the sling at four weeks they will start active range of motion and active assisted range of motion. They cannot internally rotate until 10 weeks after surgery. No formal strengthening until 3 months after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Immobilization Group | The immobilization group will be placed in a shoulder abduction sling immediately after surgery for four weeks. They will be allowed to start gentle passive range of motion with forward flexion to 120 degrees, abduction to 90 degrees, and external rotation to 30 degrees. They will receive a home exercise program and formal physical therapy with these limits.
When they come out of the sling at four weeks they will start active range of motion and active assisted range of motion. They cannot internally rotate until 10 weeks after surgery. No formal strengthening until 3 months after surgery. Receives: Other: Immobilization | |
| Early ROM | The early range of motion group will be given a sling for comfort after their surgery. They will be told they can use their arm as tolerated and can remove the sling when comfortable immediately after surgery. They will be allowed to start passive range of motion, active assisted range of motion, and gentle active range of motion with therapy as tolerated with the exception of no internal rotation. They will also not be allowed to strengthen until 12 weeks after surgery. They will get formal physical therapy and be given a home exercise program as well that will be directed by their physical therapist Receives: Other: Early Range of Motion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early postoperative range of motion
the postoperative range of motion (ROM) will be compared between the 2 groups at 2 weeks, 6 weeks, 12 weeks, 6 months, 1 year, and two years
Measured: 2 years
Postoperative Pain
Patients will rate their pain using the VAS pain scale survey. The visual analog scale (VAS) is a pain rating scale first used by Hayes and Patterson in 1921. Scores are based on self-reported measures of symptoms that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale-"no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm). This scale will be administered to both groups at 2 weeks, 6 weeks, 12 weeks, 6 months, 1 year, and 2 years. The results of these scores will be compared between the two groups at each time point.
Measured: 2 years
Shoulder function
the postoperative shoulder function assessed by the American Shoulder and Elbow Scale (ASES). This scale includes a section on pain (7 items) and a section on activities of daily living (10 items). Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition. The survey will be administered to both groups at 2 weeks, 6 weeks, 12 weeks, 6 months, 1 year, and 2 years. The results of these scores will be compared between the two groups at each time point.
Measured: 2 years
Postoperative complication
the 2 year postoperative complications will be recorded and compared between the 2 cohorts.
Measured: 2 years
Tuberosity Healing on Radiographs
Radiographic outcomes regarding the degree of tuberosity healing will be obtained at each postoperative visit until the 2 year mark and compared between the 2 cohorts
After initial imaging, patients will receive subsequent X-rays to monitor tuberosity healing, progression of fracture gap closure with bone formation, and signs of bone resorption. Healing is defined as lack of displacement with consolidation of the fracture and disappearance of previous fracture lines. Displacement will be measured in millimeters compared to position on previous xrays.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start24 Feb 2021
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Proximal Humeral FractureStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cooper Norcross Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Catherine Fedorka MD, Cooper Norcross Health
- Investigators
- Catherine J Fedorka, MD, Principal investigator, Cooper Hospital Orthopedic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06133920
- Sponsor's protocol ID
- IRB #20-533
- Status last verified
- Nov 2026
- First submitted
- 26 Jul 2023
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hagen MS, Allahabadi S, Zhang AL, Feeley BT, Grace T, Ma CB. A randomized single-blinded trial of early rehabilitation versus immobilization after reverse total shoulder arthroplasty. J Shoulder Elbow Surg. 2020 Mar;29(3):442-450. doi: 10.1016/j.jse.2019.10.005. Epub 2020 Jan 7.
PubMed 31924519Sheps DM, Silveira A, Beaupre L, Styles-Tripp F, Balyk R, Lalani A, Glasgow R, Bergman J, Bouliane M; Shoulder and Upper Extremity Research Group of Edmonton (SURGE). Early Active Motion Versus Sling Immobilization After Arthroscopic Rotator Cuff Repair: A Randomized Controlled Trial. Arthroscopy. 2019 Mar;35(3):749-760.e2. doi: 10.1016/j.arthro.2018.10.139.
PubMed 30827428Agorastides I, Sinopidis C, El Meligy M, Yin Q, Brownson P, Frostick SP. Early versus late mobilization after hemiarthroplasty for proximal humeral fractures. J Shoulder Elbow Surg. 2007 May-Jun;16(3 Suppl):S33-8. doi: 10.1016/j.jse.2006.07.004. Epub 2006 Dec 13.
PubMed 17174113
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immobilization Versus Early Range of Motion in Reverse Total Arthroplasty in Patients With Proximal Humerus Fractures
- ClinicalTrials.gov ID
- NCT06133920
- Acronym / sponsor ID
- IRB #20-533
- Keywords
- Proximal Humerus Fracture, Range of Motion, Immobilization
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cooper Norcross HealthUniversity, hospital or other
- Study start
- 24 Feb 2021 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 18 Nov 2023 (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 evaluate compare postoperative range of motion in patients who are given a sling for comfort only and allowed to start early active range of motion compared to patients who are placed in a sling for 4 weeks with passive range of motion only. Once enrolled, the patients will be randomized through computer randomization then placed in paper packets into either the immobilization group or the early range of motion group.
Detailed description
Reverse shoulder arthroplasty is often used for older patients with displaced proximal humerus fractures in the older patient population. Many surgeons have historically placed patients in a sling for 4-6 weeks after surgery to prevent dislocation or tuberosity displacement. More recently though, surgeons are becoming more lenient with these restrictions as they realize it is very difficult for an elderly patient to be immobilized for 4-6 weeks. There has been one randomized control trial looking at early range of motion versus immobilization for 6 weeks after a regular reverse total shoulder arthroplasty not done for fracture which showed no difference at one year. There have not been any studies to date looking at reverse total shoulder arthroplasty for fracture to see if there is any difference in range of motion at early or later time points and also if there is an increased risk of complications.
Preoperative visit/hospitalization: The patient will be identified as meeting inclusion criteria and the study will be explained to them. Patients will be given a consent form to review with adequate time to review and decide if they wish to participate. If they choose to participate, the patient will sign consent forms witnessed by personnel not associated with the study. Patients will be randomized once consent has been obtained.
The patient will then undergo surgery. Operative data will be collected from their chart including implants used, and intraoperative complications. They will be placed in a sling if they are randomized to the sling group and given instructions on passive range of motion exercises to start postoperative day one. If they are assigned to the early motion group they will be placed in a sling for comfort after surgery but told they can remove it when they feel their pain will allow. They will also be instructed on the same passive range of motion program as the sling group. This is different from the standard of care.
Once enrolled, the patients will be randomized through computer randomization then placed in paper packets into either the immobilization group or the early range of motion group.
They will undergo their reverse total shoulder arthroplasty for fracture as they will even if they do not agree to participate in the study (normal treatment)
The immobilization group will be placed in a shoulder abduction sling immediately after surgery for four weeks. They will be allowed to start gentle passive range of motion with forward flexion to 120 degrees, abduction to 90 degrees, and external rotation to 30 degrees. They will receive a home exercise program and formal physical therapy with these limits.
When they come out of the sling at four weeks they will start active range of motion and active assisted range of motion. They cannot internally rotate until 10 weeks after surgery. No formal strengthening until 3 months after surgery.
The early range of motion group will be given a sling for comfort after their surgery. They will be told they can use their arm as tolerated and can remove the sling when comfortable immediately after surgery. They will be allowed to start passive range of motion, active assisted range of motion, and gentle active range of motion with therapy as tolerated with the exception of no internal rotation. They will also not be allowed to strengthen until 12 weeks after surgery. They will get formal physical therapy and be given a home exercise program as well that will be directed by their physical therapist
Both groups will be evaluated postoperatively at 2 weeks, 6 weeks, 12 weeks, 6 months, 1 year, and two years. At each time point the following will be evaluated.
Visual analog pain score American Shoulder and Elbow Society Scores Range of motion Complications Radiographs will be obtained at these visits
Thereported outcome scores will either be recorded in the office or via email using the surgical outcomes system database that is already approved for use at Cooper via legal for quality outcome measures. The patient will be allowed to determine which method they would prefer and is easier for them.
All of these visits will be the same as patients who choose not to enroll in the study. No additional visits are required for the study. The only differences in treatment will be obtaining the patient outcome scores listed above and the random assignment to one of two treatment groups. The random treatment assignments are as follows; the first group of patients will be placed in a sling for four weeks but with early stretching through physical therapy, and the second group will be allowed to use the sling for comfort only and use their arm as tolerated for motion activities such as dressing and bathing. The second group will also receive physical therapy.
The results of the study will not be shared with the subjects or others unless they ask at the completion of the study at which point final data will be revealed to the subjects that ask.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immobilization Group | – | Other: ImmobilizationThe immobilization group will be placed in a shoulder abduction sling immediately after surgery for four weeks. They will be allowed to start gentle passive range of motion with forward flexion to 120 degrees, abduction to 90 degrees, and external rotation to 30 degrees. They will receive a home exercise program and formal physical therapy with these limits. When they come out of the sling at four weeks they will start active range of motion and active assisted range of motion. They cannot internally rotate until 10 weeks after surgery. No formal strengthening until 3 months after surgery. |
| Early ROM | – | Other: Early Range of MotionThe early range of motion group will be given a sling for comfort after their surgery. They will be told they can use their arm as tolerated and can remove the sling when comfortable immediately after surgery. They will be allowed to start passive range of motion, active assisted range of motion, and gentle active range of motion with therapy as tolerated with the exception of no internal rotation. They will also not be allowed to strengthen until 12 weeks after surgery. They will get formal physical therapy and be given a home exercise program as well that will be directed by their physical therapist |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients 60 years or older who have a displaced proximal humerus fracture that meet surgical criteria for a reverse total shoulder arthroplasty. Patients are not excluded based on sex
Key inclusion criteria (3 listed)
- Patients 60 years or older who have a displaced proximal humerus fracture
- Meets surgical criteria for a reverse total shoulder arthroplasty
- Receive surgical intervention within 6 weeks of initial injury
Key exclusion criteria (4 listed)
- Patients <60 years in age
- Patients who cannot undergo surgery due to medical comorbidities
- Patients who receive surgical intervention after 6 weeks from initial injury
- Patients who have preoperative nerve damage from their fractures that would limit the ability to move the arm postoperatively
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 |
|---|---|---|
| Early Range of MotionThe early range of motion group will be given a sling for comfort after their surgery. They will be told they can use their arm as tolerated and can remove the sling when comfortable immediately after surgery. They will be allowed to start passive range of motion, active assisted range of motion, and gentle active range of motion with therapy as tolerated with the exception of no internal rotation. They will also not be allowed to strengthen until 12 weeks after surgery. They will get formal physical therapy and be given a home exercise program as well that will be directed by their physical therapist | Other | Early ROM |
| ImmobilizationThe immobilization group will be placed in a shoulder abduction sling immediately after surgery for four weeks. They will be allowed to start gentle passive range of motion with forward flexion to 120 degrees, abduction to 90 degrees, and external rotation to 30 degrees. They will receive a home exercise program and formal physical therapy with these limits. When they come out of the sling at four weeks they will start active range of motion and active assisted range of motion. They cannot internally rotate until 10 weeks after surgery. No formal strengthening until 3 months after surgery. | Other | Immobilization Group |
Primary outcome
Early postoperative range of motion
Time frame: 2 years
the postoperative range of motion (ROM) will be compared between the 2 groups at 2 weeks, 6 weeks, 12 weeks, 6 months, 1 year, and two years
Postoperative Pain
Time frame: 2 years
Patients will rate their pain using the VAS pain scale survey. The visual analog scale (VAS) is a pain rating scale first used by Hayes and Patterson in 1921. Scores are based on self-reported measures of symptoms that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale-"no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm). This scale will be administered to both groups at 2 weeks, 6 weeks, 12 weeks, 6 months, 1 year, and 2 years. The results of these scores will be compared between the two groups at each time point.
Shoulder function
Time frame: 2 years
the postoperative shoulder function assessed by the American Shoulder and Elbow Scale (ASES). This scale includes a section on pain (7 items) and a section on activities of daily living (10 items). Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition. The survey will be administered to both groups at 2 weeks, 6 weeks, 12 weeks, 6 months, 1 year, and 2 years. The results of these scores will be compared between the two groups at each time point.
Postoperative complication
Time frame: 2 years
the 2 year postoperative complications will be recorded and compared between the 2 cohorts.
Tuberosity Healing on Radiographs
Time frame: 2 years
Radiographic outcomes regarding the degree of tuberosity healing will be obtained at each postoperative visit until the 2 year mark and compared between the 2 cohorts After initial imaging, patients will receive subsequent X-rays to monitor tuberosity healing, progression of fracture gap closure with bone formation, and signs of bone resorption. Healing is defined as lack of displacement with consolidation of the fracture and disappearance of previous fracture lines. Displacement will be measured in millimeters compared to position on previous xrays.
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 5 Nov 2026.
- Background: PubMed 31924519Hagen MS, Allahabadi S, Zhang AL, Feeley BT, Grace T, Ma CB. A randomized single-blinded trial of early rehabilitation versus immobilization after reverse total shoulder arthroplasty. J Shoulder Elbow Surg. 2020 Mar;29(3):442-450. doi: 10.1016/j.jse.2019.10.005. Epub 2020 Jan 7.
- Background: PubMed 30827428Sheps DM, Silveira A, Beaupre L, Styles-Tripp F, Balyk R, Lalani A, Glasgow R, Bergman J, Bouliane M; Shoulder and Upper Extremity Research Group of Edmonton (SURGE). Early Active Motion Versus Sling Immobilization After Arthroscopic Rotator Cuff Repair: A Randomized Controlled Trial. Arthroscopy. 2019 Mar;35(3):749-760.e2. doi: 10.1016/j.arthro.2018.10.139.
- Background: PubMed 17174113Agorastides I, Sinopidis C, El Meligy M, Yin Q, Brownson P, Frostick SP. Early versus late mobilization after hemiarthroplasty for proximal humeral fractures. J Shoulder Elbow Surg. 2007 May-Jun;16(3 Suppl):S33-8. doi: 10.1016/j.jse.2006.07.004. Epub 2006 Dec 13.
- 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.
Catherine J Fedorka, MD principal investigator
Cooper Hospital Orthopedic Surgery
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 Proximal Humeral Fracture and Reverse Total Shoulder Arthroplasty, run by Cooper Norcross Health 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 3 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: looking for participants now, as of the sponsor's last update on 5 Nov 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 Pietro M Gentile, BS (856-968-7079, gentile-pietro@CooperHealth.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early postoperative range of motion (time frame: 2 years). The study lists 5 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 NCT06133920, which also lists 3 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 5 Nov 2026.