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Rotator Cuff Tear clinical trials

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NCT ID: NCT03838666 Terminated - Rotator Cuff Tear Clinical Trials

Utilization of AMSC to Enhance Rotator Cuff Repair - Safety and Efficacy

AMSC-RC-001
Start date: December 12, 2012
Phase: Phase 1/Phase 2
Study type: Interventional

Subjects received perioperative hAMSC treatment in order to accelerate the healing of the surgically repaired rotator cuff and increase the mechanical properties of the tendon, according to inclusion and exclusion criteria (see below). Each patient will undergo post-operative follow-up at 6 weeks, 6 months and 12 months after the surgery. This will include a visual analogue score for pain (VAS), a questionnaire for the subjective Constant shoulder score, and the subjective questions of the University of California (UCLA) score. Preoperative and postoperative MRI at 12 months will be done to evaluate the quality of the rotator cuff repair.

NCT ID: NCT03648047 Terminated - Rotator Cuff Tear Clinical Trials

Digital Biofeedback System Versus Conventional Rehabilitation After Rotator Cuff Repair

Start date: November 11, 2018
Phase: N/A
Study type: Interventional

This study was designed to compare the clinical outcomes of a mixed home-based rehabilitation program after arthroscopic rotator cuff repair, incorporating face-to-face sessions as well as sessions performed with a novel digital kinematic biofeedback system against conventional in-person home-based rehabilitation, with the intent of reducing the need for face-to-face sessions. The investigators hypothesize that the clinical outcomes of such a program will be at least similar to those of conventional rehabilitation. Patients will be enrolled pre-operatively and then randomized into 2 groups: experimental group and conventional rehabilitation group. Both groups will perform a 12 to 16-week rehabilitation program starting immediately after surgery. Outcomes will be measured at baseline, 8 and 12 weeks. In patients where a decision is made to extend the program to 16 weeks, another assessment will be made at this point.

NCT ID: NCT03567954 Terminated - Rotator Cuff Tear Clinical Trials

The Accuracy of Ultrasound in Detecting Rotator Cuff Tears in Proximal Humerus Fracture Patients

Start date: June 22, 2018
Phase:
Study type: Observational

The aim of this study is to determine the diagnostic accuracy of ultrasonography (US) in detecting full-thickness (a lesion that extends through both the bursal and articular part of the tendon) rotator cuff tear in patients who have sustained a proximal humerus fracture, using operative examination as the golden standard.

NCT ID: NCT02211183 Terminated - Rotator Cuff Tear Clinical Trials

InSpaceā„¢ System in Comparison to Best Repair of Massive Rotator Cuff Tear

Start date: August 2014
Phase: N/A
Study type: Interventional

This is a post-marketing study to further assess the safety and effectiveness of the InSpaceā„¢ device implantation in comparison to surgical repair of full thickness Massive Rotator Cuff Tear .

NCT ID: NCT01688362 Terminated - Rotator Cuff Tear Clinical Trials

Platelet Rich Plasma vs. Corticosteroid Injection in the Treatment of Partial Rotator Cuff Tears

Start date: November 2012
Phase: Phase 1
Study type: Interventional

The purpose of this study is to further define the optimal non-surgical treatment strategy for partial thickness rotator cuff tears. The specific aim of this study is to determine the outcomes of treatment of partial thickness rotator cuff tears with corticosteroid or platelet rich plasma (PRP). Subjects with partial thickness rotator cuff tears will be randomized to receive an injection of PRP or corticosteroid. Shoulder function and tendon healing will be evaluated using the patient surveys as well as ultrasound. Subjects will be followed for one year to determine the outcomes for each treatment. The hypothesis is that there is no difference in healing rate or functional outcomes in patients treated with corticosteroid injections vs. PRP injections for the treatment of partial thickness rotator cuff tears.

NCT ID: NCT01507818 Terminated - Rotator Cuff Tear Clinical Trials

Effectiveness of the Ivivi Torino II, Pulsed Radio Frequency Device, on Narcotic Use, Pain and Quality of Life Following Shoulder Arthroscopic Rotator Cuff Repair.

Start date: December 2011
Phase: N/A
Study type: Interventional

To determine the effectiveness of non-thermal PRF delivered with the Ivivi Torino II on narcotic use, pain, and health-related quality of life following shoulder arthroscopic rotator cuff surgery comparing: Active treatment versus placebo (Sham).

NCT ID: NCT01122498 Terminated - Rotator Cuff Tear Clinical Trials

A Safety Study Of BMP-655/ACS As An Adjuvant Therapy For Treatment Of Rotator Cuff Tears

Start date: June 2010
Phase: Phase 1
Study type: Interventional

Subjects undergoing an open surgical repair for their torn Rotator Cuff (RC) will be consented, screened, and enrolled in the study if they meet all eligibility criteria. At the time of open surgical repair, subjects who are randomized to receive the test article in addition to the Standard of Care (SOC) will be hospitalized and have a single dose of BMP-655/ACS surgically implanted at the site of tendon attachment to bone. Subjects who are randomized to receive SOC alone will receive no test article. Following surgery, subjects will be prescribed a rehabilitation plan. Subjects will then complete 9 follow-up visits beginning 24 hours after surgery and continuing through 52 weeks.

NCT ID: NCT00936559 Terminated - Rotator Cuff Tear Clinical Trials

Study Evaluating Safety Of BMP-655/ACS As An Adjuvant Therapy For Rotator Cuff Repair

Start date: September 2010
Phase: Phase 1
Study type: Interventional

Study to assess the safety of 3 differing concentrations of BMP-655/ACS in subjects with full thickness Rotator Cuff Tears (RCTs).