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Rotator Cuff Injuries clinical trials

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NCT ID: NCT01788683 Completed - Rotator Cuff Tear Clinical Trials

Regenexx™ SD Versus Exercise Therapy for Rotator Cuff Tears

Start date: February 2013
Phase: N/A
Study type: Interventional

The primary objective of this study is to compare the improvement in subject-reported clinical outcomes, for Regenexx SD treatment vs. Exercise Therapy of non-retracted supraspinatus tendon tears, from baseline to 3 months, with continued evaluation of efficacy and durability up to 24 months. Secondary objectives include evaluation of US evidence of tendon repair; incidence of post-operative complications, adverse events, re-injections, and surgical intervention; change in pain score and use of pain medications.

NCT ID: NCT01778777 Completed - Clinical trials for Rotator Cuff Tear Arthropathy

Safety Study of Univers® Revers Shoulder Prosthesis

Start date: September 1, 2013
Phase: N/A
Study type: Interventional

The primary safety objective is to demonstrate that severe device-related complication (Serious Adverse Device Effect = SADE) occur within 2 years after prosthesis implantation at a rate of less than 2%. Such adverse events include (but are not limited to) revisions due to dislocation or glenoid loosening, septic arthritis and scapular fractures requiring surgical repair.

NCT ID: NCT01747902 Completed - Rotator Cuff Tear Clinical Trials

Biceps Tenodesis Versus Tenotomy

BicepsTvsT
Start date: January 2013
Phase: N/A
Study type: Interventional

The long head of biceps brachii tendon has been known to be a pain generator and a common cause of shoulder pain and dysfunction in patients with rotator cuff pathology. Both biceps tenotomy and tenodesis have been shown to produce comparable results, but there is no consensus to date due to a lack of level I evidence. The aim of this prospective, randomized, clinical trial is to compare subjective patient-reported outcomes and objective clinical results between biceps tenotomy and biceps tenodesis for treating lesions of the long head of the biceps brachii.

NCT ID: NCT01741272 Completed - Clinical trials for Full Thickness Rotator Cuff Tears

Early Mobilization Following Mini-Open Rotator Cuff Repair

Start date: September 2003
Phase: Phase 4
Study type: Interventional

The primary objective of this study is to determine if early active range of motion after mini-open rotator cuff repair in adults results in improved shoulder range of motion at 6 weeks and 3 months after surgery. The secondary objective of this study is to determine if early mobilization improves disease-specific quality of life and promotes earlier return to work/function. Hypothesis: Adults undergoing mini-open rotator cuff repair will have faster recovery of range of motion, improved disease specific quality of life and earlier return to work/function if allowed to begin early active range of motion compared to subjects who are immobilized in a sling for 6 weeks.

NCT ID: NCT01706978 Completed - Rotator Cuff Tear Clinical Trials

A Comparison of Two Adjunctive Treatments in Arthroscopic Cuff Repair

Start date: April 2012
Phase: N/A
Study type: Interventional

This Clinical Trial is being conducted to study two adjunctive treatments for rotator cuff repair; soft tissue and bone trephination. "Trephination" is a procedure that involves making small perforations either in the torn tendon near its edge, or in the bone that the tendon is repaired to. The rotator cuff is repaired by sewing the tendon down to the bone in the shoulder. Trephination is a new technique that is used in addition to the standard method of repairing the rotator cuff tendon. This study will help to determine whether this technique improves the speed of healing, the strength and the re-tear rate of the repair. You are being asked to take part in this study because you have a tear of the rotator cuff that requires surgical treatment. A total of 90 participants will participate in this study.

NCT ID: NCT01544283 Unknown status - Shoulder Pain Clinical Trials

Pain Patch Versus Injections in the Treatment of Pain Associated With Shoulder Impingement Syndrome

Start date: March 2012
Phase: Phase 2
Study type: Interventional

Objective: This purpose of this pilot study is to explore the potential usefulness of Synera for the treatment of pain associated with shoulder impingement syndrome.

NCT ID: NCT01481480 Active, not recruiting - Clinical trials for Full Thickness Rotator Cuff Tear

Latissimus Dorsi Tendon Transfer or Partial Arthroscopic Repair of Massive Rotator Cuff Tears

Start date: August 2012
Phase: N/A
Study type: Interventional

A massive tear of the rotator cuff is a debilitating condition that causes pain, significant impairments in strength, and resultant loss of activity of the affected arm. To our knowledge, there is no Level 1 evidence comparing surgical procedures to treat massive rotator cuff tears. Adding the first randomized controlled trial to will be a substantial contribution to the current body of evidence available in the subject of massive rotator cuff tears. Most studies found in the literature following patients with massive rotator cuff tears are retrospective, have small numbers of patients, offer no control group and do not adequately compare treatment methods.Moreover, there is no consensus from experts regarding which treatment is superior. Our multicentre orthopaedic study group proposes a multicentre randomized clinical trial prospectively comparing latissimus dorsi tendon transfer to arthroscopic management for the treatment of massive rotator cuff tears. This study will include the use of comprehensive functional, motor and radiographic outcome assessments.

NCT ID: NCT01459536 Completed - Rotator Cuff Tear Clinical Trials

Assessment of Muscle Function and Size in Older Adults With Rotator Cuff Tear

ARC
Start date: September 2011
Phase: N/A
Study type: Observational

Adequate upper limb function is critically important to maintenance of independence and prevention of disability in older adults. The goal of this work is to identify factors that contribute to rotator cuff rupture and improved outcomes for repair. Ultimately, the investigators seek to identify patients most at risk for rupture and to guide clinicians on optimal surgical and rehabilitation strategies. This pilot study will quantitatively characterize the morphological (muscle volume and fatty infiltration) and functional (shoulder isometric joint strength, movement when performing typical task) changes in the muscles of the rotator cuff following supraspinatus tear and surgical repair. The investigators hypothesize that patients with supraspinatus tear will have reduced muscle volume and increased fatty infiltration of rotator cuff muscles compared to their contralateral arm and age-matched controls, which will increase following surgery. The investigators further hypothesize that isometric joint strength in these individuals will be associated with muscle volume and the degree of fatty infiltration, and that older adults with a rotator cuff tear will use a restricted range of motion to accomplish functional tasks. This study emphasizes muscle function and composition with application to rehabilitation of upper limb function, which complements the theme of the Pepper Center.

NCT ID: NCT01405781 Enrolling by invitation - Shoulder Pain Clinical Trials

Functional and Radiographic Outcomes After Shoulder Surgery

Start date: May 2011
Phase:
Study type: Observational

The objective of this study is twofold: First, to determine whether higher levels of pre-operative psychological distress predict worse outcomes after arthroscopic rotator cuff repair; second, to obtain functional outcomes (VAS pain, VAS satisfaction, VAS function, Simple Shoulder Test (SST) and American Shoulder and Elbow Surgeons (ASES) Score), physically examine and perform a radiographic analysis of patients at a minimum of 6 months after reverse total shoulder arthroplasty, total shoulder arthroplasty, arthroscopic scapulothoracic bursectomy, acromioclavicular joint reconstruction and arthroscopic rotator cuff repair.

NCT ID: NCT01402011 Completed - Clinical trials for Rotator Cuff Tendinitis

Study of 25% Dextrose Injections in Shoulder Ligaments and Tendons to Promote Their Healing

Prolotherapy
Start date: November 2010
Phase: N/A
Study type: Interventional

HYPOTHESIS: Prolotherapy, the injection of a growth promoting solution in injured ligaments and tendons of the shoulder is an effective treatment that decreases pain, increases functional capacity and promotes healing better and in less time than standard treatment with physiotherapy. OVERVIEW: 75 subjects with rotator cuff tendinopathy proven by ultrasound will be recruited and assigned randomly into one of three groups of 25 to receive one of these three different treatments: Group A (test): 25% dextrose with 0.1% lidocaine, injected into the tendons and ligaments Group B (control): 0.1% lidocaine injected in the rotator cuff tendons and ligaments Group C(control): 0.1% lidocaine injected subcutaneously above these structures All subjects will receive physiotherapy every other week for three months. To avoid placebo effects, patients, the radiologist and physiotherapist will not know to which treatment group the patients belong; the physician administering the injections will not be involved in assessing disability before or after treatment. (Note: The physician will know which patients belong to group C because it will be obvious: they are delivering a subcutaneous - versus a joint - injection). There will be three sets of injections - one set per month for 3 months. The patients' condition will be tracked for nine months after the first treatment, to monitor changes in 3 outcome measures: pain (VAS and Rx #s), function (DASH and PESS), and tendon healing (as assessed by ultrasound).