Shoulder Pain ChronicNCT03797287
Arthroscopic Transosseous vs. Anchored Rotator Cuff Repair
A study testing Tensor Tunnler and Anchor Rotator Cuff Repair in people with Shoulder Pain Chronic and Shoulder Pain, run by Johns Hopkins University at 1 site in United States.
Trial summary
This study will compare arthroscopic transosseous versus anchored rotator cuff repairs in terms of clinical outcomes, rotator cuff integrity, and cost-effectiveness. With the collection of patient-reported outcomes the health of patients undergoing each rotator cuff repair technique will be assessed. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Shoulder Pain Chronic, Shoulder Pain, Rotator Cuff Tear
- What is being tested?
- Tensor Tunnler and Anchor Rotator Cuff Repair
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2020to Dec 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults age 18-75 years old
- Full thickness rotator cuff tears of any size (documented by MRI or ultrasound)
- Patients planning surgical repair with Dr. Uma Srikumaran (PI of this study) at Johns Hopkins Shoulder Service (Columbia, Odenton Clinic sites; Howard County General Hospital/Bayview/Johns Hopkins Hospital operative sites)
Who cannot join
- Patients with partial tears, massive rotator cuff tears that are irreparable, isolated subscapularis tears, and associated pathology (advanced degenerative changes)
- Patients undergoing revision rotator cuff tears will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Arthroscopic Transosseous vs. Anchored Rotator Cuff Repair: A Randomized Clinical Trial
This study will compare arthroscopic transosseous versus anchored rotator cuff repairs in terms of clinical outcomes, rotator cuff integrity, and cost-effectiveness. With the collection of patient-reported outcomes the health of patients undergoing each rotator cuff repair technique will be assessed. The aims of this study will be achieved through a clinical randomized controlled trial and a cost-effectiveness analysis.
Read the detailed description
Study Design: After the decision to proceed with arthroscopic rotator cuff repair, patients will be asked to participate in this prospective randomized clinical trial.
Study Procedures:
Before Surgery: The Informed Consent process will be completed prior to any data collection. Consent will be completed after explanation of each treatment group and the data to be collected. Baseline and demographic data will be collected prior to surgery:
Randomization: Subjects will be randomized prior to surgery into one of the two rotator cuff repair technique groups using REDCap software. Randomization will be stratified by gender.
Patient Visits:
Patients will complete their questionnaires and testing before surgery then within 2 weeks, 3 months, 6 months, 1 year, and 2 years After the first week of surgery, patients will be given a pain diary to record all narcotic pain medications they consume during the 1st week post-op.
An ultrasound will be done during their 6 month, 1 year, and 2 year follow up.
- Being tested
- Tensor Tunnler, Anchor Rotator Cuff Repair
- Medical subject headings
- Shoulder Pain, Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tensor TunnlerDevice
Create the bone tunnels during the arthroscopic rotator cuff repair procedure
Anchor Rotator Cuff RepairProcedure or surgery
The suture anchors (Smith and Nephew PEEK Helicoil Anchor) are inserted in bone and the sutures are then used to sew the tendons to bone arthroscopically.
| Study group | Role | What they receive |
|---|---|---|
| Tensor Tunnler | Experimental | The Tensor Tunneler (Chattanooga, TN) will be used to create the bone tunnels during the arthroscopic procedure. This is an FDA approved device and is used currently in routine clinical practice. Receives: Device: Tensor Tunnler |
| Smith and Nephew PEEK Helicoil Anchor | Active comparator | The anchors used in this trial are FDA approved and are used currently in routine clinical practice (Anchor Rotator Cuff Repair). Receives: Procedure: Anchor Rotator Cuff Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in condition of the shoulder as assessed by American Shoulder and Elbow Surgeon (ASES) Score
10 separate questions is scored on an ordinal scale from 0-3 for a maximal raw functional score of 30 (no difficulties).
Measured: Before surgery, 2 weeks, 3 months, 6 months, and 1 year after surgery
Secondary outcomes (6)
Change in shoulder pain as assessed by Visual Analog Pain Score
Patients are asked to identify whether they are having pain in the shoulder and are asked to record the location of their pain on a 10 cm line that ranges from 0(no pain at all) to 10 (pain as bad as it can be)
Measured: Before surgery, 2 weeks, 3 months, 6 months, and 1 year after surgery
Change in Range of Motion (ROM)
Total (combined glenohumeral and scapulothoracic) shoulder motion is measured. Both active and passive motion for both shoulders is recorded. Forward elevation is measured as the maximum arm-trunk angle viewed from any direction. External rotation is measured with the arm comfortably at the side and also with the arm at 90° of abduction. Internal rotation is measured by noting the highest segment of spinal anatomy reached with the thumb. Cross-body adduction is measured by measuring the distance of the antecubital fossa from the opposite acromion.
Measured: Before surgery, within 1 month after surgery, 3 months, 6 months, 1 year
Change in Strength Testing
Strength is graded according to the Medical Research Council grade. Strength is measured in forward elevation, abduction, external rotation with the arm comfortably at the side, and internal rotation with the arm comfortably at the side. A perfect score is a 5 in each category.
Measured: Before surgery, 2 weeks, 3 months, 6 months, and 1 year after surgery
Change in quality of life as assessed by the Western Ontario Rotator Cuff (WORC) Index
Quality of Life Measurement tool for patients with rotator cuff disease where patients mark a line on 21 visual analogue scale (VAS) lines labeled 0 (not affected) - 100 (affected). These items will ask about physical symptoms, sports and recreation, work, social function, and emotions. The maximum score is 2100 for worst possible symptoms and 0 represents no symptoms at all.
Measured: Before surgery, 1 year after surgery, 2 years after surgery
Change in health related quality of life as assessed by Short-Form Six-Dimension (SF-6D)
Measures of health related quality of life (HRQoL) using 11 items from the SF-36 or SF-12. Patients are asked about their physical functioning, role limitations, social functioning, pain, mental health, and vitality. A score of 1 represents full health.
Measured: Before surgery, 2 weeks, 3 months, 6 months, and 1 year after surgery
Implant Cost
Review of costs through our billing department
Measured: Within 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2019
- Study start1 Feb 2020 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Why it stopped: IRB will be terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder Pain ChronicStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Uma Srikumaran, MD, MBA, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03797287
- Sponsor's protocol ID
- IRB00046834
- Status last verified
- May 2019
- First submitted
- 7 Jan 2019
- Last updated
- 30 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arthroscopic Transosseous vs. Anchored Rotator Cuff Repair: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03797287
- Acronym / sponsor ID
- IRB00046834
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: IRB will be terminated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 1 Feb 2020 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 9 Jan 2019 (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 compare arthroscopic transosseous versus anchored rotator cuff repairs in terms of clinical outcomes, rotator cuff integrity, and cost-effectiveness. With the collection of patient-reported outcomes the health of patients undergoing each rotator cuff repair technique will be assessed. The aims of this study will be achieved through a clinical randomized controlled trial and a cost-effectiveness analysis.
Detailed description
Study Design: After the decision to proceed with arthroscopic rotator cuff repair, patients will be asked to participate in this prospective randomized clinical trial.
Study Procedures:
Before Surgery: The Informed Consent process will be completed prior to any data collection. Consent will be completed after explanation of each treatment group and the data to be collected. Baseline and demographic data will be collected prior to surgery:
Randomization: Subjects will be randomized prior to surgery into one of the two rotator cuff repair technique groups using REDCap software. Randomization will be stratified by gender.
Patient Visits:
Patients will complete their questionnaires and testing before surgery then within 2 weeks, 3 months, 6 months, 1 year, and 2 years After the first week of surgery, patients will be given a pain diary to record all narcotic pain medications they consume during the 1st week post-op.
An ultrasound will be done during their 6 month, 1 year, and 2 year follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tensor Tunnler | Experimental | Device: Tensor TunnlerThe Tensor Tunneler (Chattanooga, TN) will be used to create the bone tunnels during the arthroscopic procedure. This is an FDA approved device and is used currently in routine clinical practice. |
| Smith and Nephew PEEK Helicoil Anchor | Active comparator | Procedure: Anchor Rotator Cuff RepairThe anchors used in this trial are FDA approved and are used currently in routine clinical practice (Anchor Rotator Cuff Repair). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults age 18-75 years old
- Full thickness rotator cuff tears of any size (documented by MRI or ultrasound)
- Patients planning surgical repair with Dr. Uma Srikumaran (PI of this study) at Johns Hopkins Shoulder Service (Columbia, Odenton Clinic sites; Howard County General Hospital/Bayview/Johns Hopkins Hospital operative sites)
Key exclusion criteria (2 listed)
- Patients with partial tears, massive rotator cuff tears that are irreparable, isolated subscapularis tears, and associated pathology (advanced degenerative changes)
- Patients undergoing revision rotator cuff tears will be excluded.
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 |
|---|---|---|
| Tensor TunnlerCreate the bone tunnels during the arthroscopic rotator cuff repair procedure | Device | Tensor Tunnler |
| Anchor Rotator Cuff RepairThe suture anchors (Smith and Nephew PEEK Helicoil Anchor) are inserted in bone and the sutures are then used to sew the tendons to bone arthroscopically. | Procedure or surgery | Smith and Nephew PEEK Helicoil Anchor |
Primary outcome
Change in condition of the shoulder as assessed by American Shoulder and Elbow Surgeon (ASES) Score
Time frame: Before surgery, 2 weeks, 3 months, 6 months, and 1 year after surgery
10 separate questions is scored on an ordinal scale from 0-3 for a maximal raw functional score of 30 (no difficulties).
6 secondary outcomes
Change in shoulder pain as assessed by Visual Analog Pain Score
Time frame: Before surgery, 2 weeks, 3 months, 6 months, and 1 year after surgery
Change in Range of Motion (ROM)
Time frame: Before surgery, within 1 month after surgery, 3 months, 6 months, 1 year
Change in Strength Testing
Time frame: Before surgery, 2 weeks, 3 months, 6 months, and 1 year after surgery
Change in quality of life as assessed by the Western Ontario Rotator Cuff (WORC) Index
Time frame: Before surgery, 1 year after surgery, 2 years after surgery
Change in health related quality of life as assessed by Short-Form Six-Dimension (SF-6D)
Time frame: Before surgery, 2 weeks, 3 months, 6 months, and 1 year after surgery
Implant Cost
Time frame: Within 1 month after surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2019.
- 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. This study is not recruiting at the moment.
Uma Srikumaran, MD, MBA principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tensor Tunnler and Anchor Rotator Cuff Repair in people with Shoulder Pain Chronic and Shoulder Pain, run by Johns Hopkins University 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 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: withdrawn, as of the sponsor's last update on 30 May 2019. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change in condition of the shoulder as assessed by American Shoulder and Elbow Surgeon (ASES) Score (time frame: Before surgery, 2 weeks, 3 months, 6 months, and 1 year after surgery). 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 30 May 2019.