CLINICAL TRIAL

Treatment for Rotator Cuff Tears

Recruiting · 18+ · All Sexes · Columbia, MO

This study is evaluating whether different techniques used in the creation of suture anchor sockets following rotator cuff repair may influence post-op pain.

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About the trial for Rotator Cuff Tears

Eligible Conditions
Rotator Cuff Injuries · Rotator Cuff Tears · Pain, Postoperative

Treatment Groups

This trial involves 2 different treatments. Treatment 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.

Control Group 1
suture anchor socket creation with punch
PROCEDURE
Control Group 2
suture anchor socket creation with drill
PROCEDURE

Eligibility

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

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
a. Patient's aged 18-80 years old with diagnosis of rotator cuff tear having failed non-operative management and being indicated for surgical intervention with use of suture anchors.
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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 to 6 months
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 weeks to 6 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 2 weeks to 6 months.
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 Treatment will improve 4 primary outcomes and 1 secondary outcome in patients with Rotator Cuff Tears. Measurement will happen over the course of 2 weeks.

MRI of the shoulder
2 WEEKS
MRI of the shoulder of the first 5 patients in each group will be obtained at 2 weeks post-op for evaluation of bone marrow edema pattern in the proximal humerus
2 WEEKS
VAS
POST-OP TO 6 MONTHS
Patient Reported Outcome Measure - pain Scale: 0-10. 0 being no pain and 10 being unbearable pain
POST-OP TO 6 MONTHS
PROMIS Short Form - Pain Interference
2 WEEKS TO 6 MONTHS
The PROMIS(r) Pain Interference instruments (adult and child) measure the self-reported consequences of pain on relevant aspects of a person's life. Each question usually has five response options ranging in value from one to five. To find the total raw score for a short form with all questions answered, sum the values of the response to each question. Answers are rated 1-5, 1 being no pain and 5 being very severe.
2 WEEKS TO 6 MONTHS
SANE
2 WEEKS TO 6 MONTHS
The Single Assessment Numeric Evaluation (SANE) is a simple, one-question patient-reported outcome measure. A SANE score requires the patient to rate their knee function on a scale of 0 to 100.
2 WEEKS TO 6 MONTHS
PROMIS Short Form - Physical Function
2 WEEKS TO 6 MONTHS
PROMIS Physical Function instruments measure self-reported capability rather than actual performance of physical activities. This includes the functioning of one's upper extremities (dexterity), lower extremities (walking or mobility), and central regions (neck, back), as well as instrumental activities of daily living, such as running errands. A single Physical Function capability score is obtained from a short form.Each question usually has five response options ranging in value from one to five. To find the total raw score for a short form with all questions answered, sum the values of the response to each question. Answers are rated
2 WEEKS TO 6 MONTHS

Patient Q & A Section

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

What is rotator cuff tears?

Rotator cuff tears result in a range of symptoms that decrease quality of life, as well as a deterioration in shoulder function and a decrease in work productivity, as shown in the present analysis, and a long-term follow-up. In a recent meta-analysis of the available evidence it seems that there is good evidence that patients with rotator cuff tears are worse than their healthy counterparts at 2 years regarding their shoulder function, pain, disability, sleep disturbance, and anxiety.

Anonymous Patient Answer

Can rotator cuff tears be cured?

Only in the case of tears of 2 or more full-thickness tears, repair is the preferred treatment modality. Repair leads to improved functional results, and a high proportion of patients are satisfied with the outcome of their treatment.

Anonymous Patient Answer

What causes rotator cuff tears?

Data from a recent study demonstrated that tear strength is highly dependent upon individual intrinsic factors. A variety of different risk factors such as age, occupation, and repetitive activity in sport predispose individuals to rotator cuff tears. Therefore, there is no single etiology, and tear causation should be considered a syndrome.

Anonymous Patient Answer

What are the signs of rotator cuff tears?

When physical examination reveals the absence of pain and stiffness in the shoulder, ultrasound is recommended for a clearer visualization of the rotator cuff and a differential diagnosis to exclude other diagnoses. When physical examination data is inconclusive or when ultrasound examination reveals an apparent lesion but a normal physical examination, a magnetic resonance imaging (MRI) is recommended.

Anonymous Patient Answer

What are common treatments for rotator cuff tears?

Results from a recent paper identifies a variety of rotator cuff tears and methods of treatment ranging from conservative to total repair. It also discusses the best timing for rotator cuff repair to be performed.

Anonymous Patient Answer

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

Approximately 7% of all adults are affected by rotator cuff tears. These patients frequently complain of pain, muscle atrophy (atrophy of the neck of the humerus and clavicles), and swelling of their shoulder.

Anonymous Patient Answer

What are the common side effects of treatment?

With appropriate treatment, people with rotator cuff tears typically have relatively few problems with shoulder pain and stiffness despite persistent atrophy and degeneration of the shoulder. Pain and stiffness in the long term are far more likely when there are signs and symptoms from other shoulder, arm, or shoulder girdle conditions.

Anonymous Patient Answer

What is the average age someone gets rotator cuff tears?

The literature suggests the average age with a rotator cuff tear is approximately 50 years old, but in our experience, a majority (over half) of rotator cuff tears are seen in patients <50 years old. The average tear size is approximately 33 mm x 27 mm which is less than the size of a small orange.

Anonymous Patient Answer

What does treatment usually treat?

The pain and swelling that occur following shoulder surgery is usually relieved by conservative treatment with non-steroidal anti-inflammatory drugs (NSAIDs) and rest. If conservative treatment does not relieve the swelling, surgery may be used to remove the tear from the shoulder. Surgery may also be used if conservative treatment does not work. In some cases, the shoulder is fitted with a biceps tendon transfer and the shoulder stiffness decreases. If the tendon transfer worked, but a second surgery is required to remove the bicep tendon, the tendon transfer could be fitted for a third and final surgery.

Anonymous Patient Answer

Have there been other clinical trials involving treatment?

Clinical trials were conducted to evaluate the effectiveness of alternative treatments. Trials have been conducted utilizing anabolic steroid injections and physiotherapy for patients with rotator cuff tears. No other trials that examined other treatments have been found. Further research is needed for a more thorough search.

Anonymous Patient Answer

Have there been any new discoveries for treating rotator cuff tears?

In the twenty years from 1986 to 2006, there has been no major new discoveries for treating rotator cuff tears. There was an increased use of a combination of two or more steroid injections and some use of rotator cuff repair for patients in which repair was considered. A large randomized, blinded, multicenter clinical trial comparing patients in which repair was done and with which the patients were only treated with a shoulder rehabilitation program has not begun.

Anonymous Patient Answer

Has treatment proven to be more effective than a placebo?

In the study, patients with subacromial impingement or rotator cuff tears benefited from a subacromial decompressive exercise intervention, and the combination exercise intervention was even more effective than subacromial decompressive exercise. A placebo group that was monitored for at least 6 months demonstrated no additional benefits from this exercise intervention. Overall, the results of the study indicate that subacromial impingement may resolve without intervention (i.e., in the natural history of the condition), but recovery may be more rapid if the patients are given this exercise intervention.

Anonymous Patient Answer
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