Clinical Trials Logo

Clinical Trial Summary

The overall goal of doing this study is to improve long term patient function and outcomes in the healing rates of Rotator Cuffs. The investigators would also like to see if this method can be more cost effective and time efficient for Rotator Cuff evaluation during arthroscopy.


Clinical Trial Description

Background or rationale for this study:

4.5 million Patient's seek medical care for shoulder pain annually in the United States.

250,000 patients receive rotator cuff surgery in the United States annually. Those rotator cuff surgeries produce a societal savings of $3.44 billion per year; averaging $13,771.00 per patient younger than age 61. In which case rotator cuff tears Increases with age.

The Societal and Economic Value of Rotator Cuff Repair (AAOS) 2015 Rotator cuff repairs result in a lifetime societal savings in the U.S. of approximately $3.44 billion annually. Societal savings offset the direct costs of treatment in patients younger than age 61, resulting in an average net savings of $13,771 per patient. This number significantly increased to $77,662.00 for patients younger than 40 years of age.

Common problem, a 55 year-old man injured his left arm. He uses a sling and has difficulties performing simple activities. 1 week later he falls develops immediate pain in his shoulder. On examination he is unable to move his left arm in any upward or sideways direction without supporting it with his other arm. Radiographs he brought show no signs of shoulder osteoarthritis, dislocation, or fracture.

Shoulder pain is the third most common musculoskeletal reason for seeking medical care. Although smaller tears are less likely to propagate, larger tears tend to progress with time and eventually may become irreparable because of significant tendon retraction, muscle atrophy, or both or when the tendons tissue quality does not allow repair.

In 1972-Neer proposed that 95% of rotator cuff injuries were caused by mechanical compression under the coracoacromial arch, others argued cuff tear caused spur formation.

- Type I-flat

- Type II-curved

- Type III-hooked

Multifactorial:

Extrinsic factors;

- Subacromial impingement

- Glenohumeral instability

- Internal impingement

- Trauma (acute/repetitive) Intrinsic Factors;

- Tendon vascular supply

- Collagen fiber abnormalities

A positive painful arc test result and positive external rotation resistance test result were the most accurate finding for detecting Rotator Cuff Disease; whereas the presence of a positive lag tests (external or internal rotation) result was most accurate for diagnosis of a full-thickness rotator cuff tear. Differentiating a full thickness tear from a partial tear, the most sensitive test was the belly-press test (56.8%), and the most specific was the lift-off test (96.95).

Bone microvascularization of the footprint plays a role in rotator Cuff healing. The use of the Pinpoint may play a pivotal role in rotator Cuff healing, en lieu of Plasma Rich platelets with variable results based on concentration levels.

6 level randomized controlled trials showed no clinically significant differences in Constant scores, University of California, Los Angles shoulder rating (UCLA), and American Shoulder and Elbow Surgeons (ASES) scores between double-row and single-row rotator cuff repair. Overall odds ratio (OR) of intact rotator cuff tendon healing was 1.93 in patients treated with double-row versus single-row repair, and the difference was significant.

A statistically significant benefit of double-row repair in the ASES and UCLA scores was observed in the subgroup with tears greater than 3cm. The take home point; Double row may improve structural healing: Clinical Relevance?

9 studies in the meta-analysis, 5 of which were randomized prospective studies (LEVEL1).

Double-row rotator cuff repair techniques have a significantly lower re-tear rate, higher ASES score and greater range of motion of internal rotation compared with single-row repair techniques. Point: Especially in those rotator cuff tears with a size >30mm, the double-row technique is recommended for repair.

This was a Level 4 study out of the Cleveland Clinic which showed the majority of the tears occurred between 6 and 24 weeks. The role of a potential hand held device can assess the tendon quality in the office and change the rehab protocols based on tendon retraction.

Role for study interventions:

- Assessing the bony vascularity at the footprint and the tendon integrity.

- Current standard of care:

Steroid injection as a non-operatively treatment option. Could the steroid injections be affecting the tendon micro vascularization? Could using the Pinpoint assess tendon quality and long term healing a potential.

- Cystic osseous resorption and osteolysis.

- Breakdown products (PLLA) cause synovitis and chondrolysis.

- Breakdown products (PLLA) may interfere with healing-Complications of Bioabsorbable Suture anchors in the shoulder.

Why Medical Row Knots?

- Enhances Biology be sealing footprint from synovial fluid.

- Compared to knotless medical row, better biomechanics incl. load to failure, stiffness, less gap formation.

- A biomechanical comparison of 2 technical of double-row rotator cuff fixation: the importance of medical row knots.

Clinical Implications and Surgeon's Role;

- Choice of a tissue-penetrating instrument; smaller penetrating devices resulting in improves characteristics of stitch holding strength.

- Size of the tissue bite; bigger bite size being stronger.

- Most critical variable under a surgeons control during a rotator cuff repair is the choice of the stitch.

Role for Pinpoint:

In the re-tear and partial-repair groups, postoperative tendon preservation at the middle fact significantly affected the Japanese Orthopaedic Assocation (JOA) and UCLA scores (P=.014, respectively). Considering the patients with tendon healing had better clinical factors, the Pinpoint may help identify the tendon and footprint vascularity at time of surgery.

Goals for the Pinpoint:

To attempt to show that increased vascularity may have an effect of the muscle quality, therefore improving the strength and function long term.

Objective:

- This prospective study aims to obtain the accurate level within a range of a 95% CI imaging Rotator Cuff tendons and the footprint.

- Ensure the Vascularity of the tendon after the footprint and the tendon have been restored to the anatomic footprint. See if the level of the Rotator Cuff bite affects the vascular flow of the tendon.

- Does tying the medical row or excessive tension change the vascularity of the Rotator Cuff.

- We would like to see if by using the Pinpoint system it may be more cost effective then Plasma Rich Platelet.

- Decrease the number of the re-tear rates in Rotator cuff repairs.

Overall goals: Improve long term patient function and outcomes. Increase Rotator Cuff healing rates. Cost effective and time efficient method of Rotator Cuff evaluation during arthroscopy.

Procedures involved (Research Interventions)

Patients undergoing a Rotator Cuff Repair:

- Pre-operatively Questioners to be completed at pre-op American Shoulder and Elbow Surgeons (ASES), University California Los Angeles (UCLA), Disabilities of the arm, shoulder and hand (DASH), Short Form Health Survey-12 (SF-12) & Short Form Health Survey-36 (SF-36)

- Operative Collect OR information

- Post-operative ASES, UCLA, DASH SF-12 & SF-36

- Ultra sounds 3 months, 6 months, 1 year and 24 months

The operative intervention will proceed as current standard protocol dictates for the described procedure. No changes in the operative technique will be undertaken apart from injection of the dye and visualization with the camera. The idea would be to place the Pinpoint probe within the subacrominal space, to check the vascular status of the tendon, and then take a bite of the tendon and place the pinpoint back to check if the vascularity has decreased. The Indocyanin Green dye kit will be used along with the PINPOINT system . Patients with potential allergies or a history of allergies or sensitivity to sodium iodide or iodinated contrast agents should not use this system, and will not be asked to participate. The possible adverse reactions are, anaphylaxis, Hypotension, tachycardia, dyspnea and urticarial. The duration of the procedure will be increased because of the study imaging; this could be 15 to 30 minutes. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03001050
Study type Interventional
Source Loma Linda University
Contact
Status Withdrawn
Phase N/A
Start date December 20, 2017
Completion date December 20, 2017

See also
  Status Clinical Trial Phase
Completed NCT03663036 - Arthroscopic Superior Capsular Reconstruction With Fascia Lata Autograft - Survivorship of the Autograft Analysis N/A
Withdrawn NCT03319784 - Analysis for NSAID VS Corticosteroid Shoulder Injection in Diabetic Patients Phase 4
Suspended NCT03290196 - The Effect of EXPAREL® on Postsurgical Pain, and the Use of Narcotics Phase 4
Recruiting NCT03091075 - Oxandrolone Rotator Cuff Trial Phase 2
Completed NCT03380533 - Buprenorphine Transdermal Patches in Arthroscopic Rotator Cuff Repair Phase 2/Phase 3
Completed NCT04566939 - A Long Term Follow-Up of Rotator Cuff Tear Patients Treated With Integrated Complementary and Alternative Medicine
Active, not recruiting NCT02716441 - Rotator Cuff Failure With Continuity
Completed NCT03540030 - Opioid-Free Shoulder Arthroplasty Phase 4
Completed NCT02298023 - Treatment of Tendon Injury Using Allogenic Adipose-derived Mesenchymal Stem Cells (Rotator Cuff Tear) Phase 2
Completed NCT02850211 - A Selective COX-2 Inhibitor Provides Pain Control But Hinders Healing Following Arthroscopic Rotator Cuff Repair Phase 4
Completed NCT01383239 - Impact of Postoperative Management on Outcomes and Healing of Rotator Cuff Repairs N/A
Completed NCT01459536 - Assessment of Muscle Function and Size in Older Adults With Rotator Cuff Tear N/A
Terminated NCT00936559 - Study Evaluating Safety Of BMP-655/ACS As An Adjuvant Therapy For Rotator Cuff Repair Phase 1
Completed NCT01170312 - Arthroscopic Surgery and Platelet Rich Plasma In Rotator Cuff Tear Evaluation N/A
Completed NCT01204606 - Arthroscopic Rotator Cuff Repair With Multimodal Analgesia(MMA) N/A
Active, not recruiting NCT00852657 - Comparison of Tendon Repair and Physiotherapy in the Treatment of Small and Medium-sized Tears of the Rotator Cuff N/A
Active, not recruiting NCT00182299 - An RCT to Compare the Outcomes of Patients With Large Rotator Cuff Repair That Undergo Repair With or Without SIS Phase 4
Completed NCT02644564 - Early Clinical Examination and Ultrasonography Screening of Acute Soft Tissue Shoulder Injuries N/A
Recruiting NCT03739749 - Arthroscopic Superior Capsular Reconstruction - Study of Different Types of Grafts N/A
Completed NCT03822182 - Single Shot Liposomal Bupivicaine in Rotator Cuff Surgery Phase 4