CLINICAL TRIAL

Experimental group(Bursa Implantation) for Rotator Cuff Tears

Recruiting · 18+ · All Sexes · Houston, TX

This study is evaluating whether a new surgical technique may help improve the recovery of individuals who have had rotator cuff surgery.

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About the trial for Rotator Cuff Tears

Treatment Groups

This trial involves 2 different treatments. Experimental Group(Bursa Implantation) is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Experimental group(Bursa Implantation)
PROCEDURE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Control Group(Standard of Care)
PROCEDURE

Eligibility

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Present with rotator cuff tears requiring arthroscopic repair as confirmed by a medical expert
Are able to provide informed consent
Can commit to study follow-up visits or procedures
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 2 weeks after surgery,6 weeks after surgery,3 months after surgery,6 months after surgery,1 year after surgery,2 years after surgery
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 weeks after surgery,6 weeks after surgery,3 months after surgery,6 months after surgery,1 year after surgery,2 years after surgery
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 2 weeks after surgery,6 weeks after surgery,3 months after surgery,6 months after surgery,1 year after surgery,2 years after surgery.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Experimental group(Bursa Implantation) will improve 6 primary outcomes and 2 secondary outcomes in patients with Rotator Cuff Tears. Measurement will happen over the course of 12 months post surgery.

Number of participants with improvement in tendon organization as assessed using quantitative postoperative ultrashort magnetic resonance imaging (UTE-MRI) using the same MRI scans from the 6- and 12-month time points.
12 MONTHS POST SURGERY
12 MONTHS POST SURGERY
Number of participants with improvement in structural integrity as assessed by postoperative MRI
12 MONTHS POST SURGERY
12 MONTHS POST SURGERY
Change in range of motion
2 WEEKS AFTER SURGERY,6 WEEKS AFTER SURGERY,3 MONTHS AFTER SURGERY,6 MONTHS AFTER SURGERY,1 YEAR AFTER SURGERY,2 YEARS AFTER SURGERY
range of motion will be measured using a goniometer
2 WEEKS AFTER SURGERY,6 WEEKS AFTER SURGERY,3 MONTHS AFTER SURGERY,6 MONTHS AFTER SURGERY,1 YEAR AFTER SURGERY,2 YEARS AFTER SURGERY
Change in functional limitations of shoulder as measured by the Simple Shoulder Test(SST)
2 WEEKS AFTER SURGERY,6 WEEKS AFTER SURGERY,3 MONTHS AFTER SURGERY,6 MONTHS AFTER SURGERY,1 YEAR AFTER SURGERY,2 YEARS AFTER SURGERY
The SST consists of 12 questions with dichotomous (yes/ no) response options. For each question, the patients indicate that they are able or are not able to do the activity. The scores range from 0 (worst) to 12(best)
2 WEEKS AFTER SURGERY,6 WEEKS AFTER SURGERY,3 MONTHS AFTER SURGERY,6 MONTHS AFTER SURGERY,1 YEAR AFTER SURGERY,2 YEARS AFTER SURGERY
Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) Computer Adaptive Tests (CATs)
2 WEEKS AFTER SURGERY,6 WEEKS AFTER SURGERY,3 MONTHS AFTER SURGERY,6 MONTHS AFTER SURGERY,1 YEAR AFTER SURGERY,2 YEARS AFTER SURGERY
PROMIS CAT-PF is scored on a scale from 20-80, where a higher number indicates higher function
2 WEEKS AFTER SURGERY,6 WEEKS AFTER SURGERY,3 MONTHS AFTER SURGERY,6 MONTHS AFTER SURGERY,1 YEAR AFTER SURGERY,2 YEARS AFTER SURGERY
Change in pain of shoulder as measured by the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES)
2 WEEKS AFTER SURGERY,6 WEEKS AFTER SURGERY,3 MONTHS AFTER SURGERY,6 MONTHS AFTER SURGERY,1 YEAR AFTER SURGERY,2 YEARS AFTER SURGERY
This is scored form 0-100,lower score means worse pain
2 WEEKS AFTER SURGERY,6 WEEKS AFTER SURGERY,3 MONTHS AFTER SURGERY,6 MONTHS AFTER SURGERY,1 YEAR AFTER SURGERY,2 YEARS AFTER SURGERY
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Who is running the study

Principal Investigator
J. M. G.
Prof. James M. Gregory, Assistant Professor
The University of Texas Health Science Center, Houston

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get rotator cuff tears a year in the United States?

A study of individuals 50 years and older demonstrates more than two-thirds of the U.S. population has at least one rotator cuff tendon abnormality. The highest numbers of tendon tears are for the subscapularis tendon (38.9%) and biceps tendon (26.8%).

Anonymous Patient Answer

Can rotator cuff tears be cured?

The outcomes of rotator cuff repair vary widely, with the most common failure being re-rupture of repair. Although most re-ruptures can be managed with repeat procedures, a significant proportion must be managed with index procedures, of which cuff repair yields good results the vast majority of the time. A small proportion fails with non-specific management (i.e. watchful waiting), which is difficult to define with the available data. The most successful outcome after re-rupture is when the cuff is treated by repair, which usually will prevent further re-rupture.

Anonymous Patient Answer

What are common treatments for rotator cuff tears?

The surgical treatment most frequently used by orthopaedic surgeons is an arthrotomy, followed by repair of a cuff tear. The arthrotomy has a low recurrence rate for full healing of the cuff tear and is recommended in all cases with intact biceps tendon. The arthrotomy is recommended as the treatment of choice for partial-thickness or full-thickness tears in all cases, regardless of patient age or severity of the rotator cuff tear. The arthrotomy can be carried out laproscopically or from an endoscopic approach.

Anonymous Patient Answer

What is rotator cuff tears?

Rotator cuff injuries are common in athletic young female athletes. Imaging studies are an essential part of a comprehensive assessment of this disease state. The diagnosis of rotator cuff tears is difficult to make on clinical criteria alone. Clinical examination combined with MRI may provide more information that allows the establishment of a definite diagnosis.

Anonymous Patient Answer

What are the signs of rotator cuff tears?

A sudden onset of shoulder pain is the key to recognizing an acute rotator cuff tear in a young, healthy person. The patient should be asked to look at the other hand and rotate the shoulder to search for a tear. A patient with pain that worsens within a few days should be advised to undergo a magnetic resonance imaging, preferably on a multi-slice or a multi-detector row system, which allows for faster and more precise imaging. The presence of any fluid or fatty degeneration within the tear should be noted along with the thickness of the full-thickness tears.

Anonymous Patient Answer

What causes rotator cuff tears?

The rotator cuff is the most common site of rotator cuff tears in subjects with shoulder symptomatology, including subacromial impingement syndrome. An exhaustive assessment of shoulder symptomatology should be part of the workup for diagnosing subacromial impingement.

Anonymous Patient Answer

Does rotator cuff tears run in families?

Familial shoulder diseases of an undetermined etiology are not uncommon. In our cohort, the inheritance of these diseases exhibited an X-linked recessive pattern. When they affect two male members of a family, this underscores the need for early recognition and management.

Anonymous Patient Answer

What is the primary cause of rotator cuff tears?

The most common underlying causes of rotator cuff tears were tear of the supraspinatus tendon and degenerative changes. A minority of patients, however, had an acute traumatic tendon tear, and a smaller group had bursitis of the rotator cuff as only contributing factor. The primary cause of the majority of rotator cuff tears is idiopathic.

Anonymous Patient Answer

What is the latest research for rotator cuff tears?

A recent Cochrane review showed that there is not enough high-quality evidence to conclude on the treatment of adhesive capsulitis. Two studies showed reduced shoulder pain and other symptoms. Another study reported fewer symptoms when injecting the shoulder with corticosteroids. One trial found that the injections reduced pain more than the placebo. A third trial showed that steroid injections may be just as good or a better option than arthroscopic surgery. A fifth trial found patients treated with injections received one treatment less of pain and stiffness than the placebo. Another study reported pain scores improved. A sixth trial found patients with symptoms of adhesive capsulitis who underwent arthroscopic treatment had fewer symptoms than those who received injection or did not undergo treatment.

Anonymous Patient Answer

How serious can rotator cuff tears be?

There is a risk of worsening symptoms and, in some patients, complete shoulder deterioration. A full-thickness tear can often give rise to shoulder pain and stiffness that are resistant to treatments.

Anonymous Patient Answer

Have there been other clinical trials involving experimental group(bursa implantation)?

No clinical trials have included an experimental group(bursa implantation)/control group(surgery, surgery, or no intervention). A follow-up period of less than one year in most of the studies may be too short a duration to have significant clinical implications.

Anonymous Patient Answer

What are the common side effects of experimental group(bursa implantation)?

The most common common side effects of experimental group(bursa implantation) were transient pain during surgery (1.4%); postoperative edema with subclinical effusion(1.3% vs. 0.2%); and effusion(0.1% vs. 0.0%); but these are not serious side effects. The side effects were not associated with gender.

Anonymous Patient Answer
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