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Rotator Cuff Tear clinical trials

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NCT ID: NCT01877772 Completed - Rotator Cuff Tear Clinical Trials

Trephination in Arthroscopic Cuff Repair: a Prospective Randomized Controlled

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

This Clinical Trial is being conducted to study an adjunctive treatment for rotator cuff repair; bone trephination."Trephination" is a procedure that involves making small perforations 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. The control group will undergo the standard repair for rotator cuff tears. It is the investigators' hypothesis that healing rates in patients who undergo bone trephination will be higher compared with surgery without trephination in arthroscopic rotator cuff repair at 24 months post-operatively.

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: NCT01767740 Completed - Rotator Cuff Tear Clinical Trials

Pilot Study of the Use of ULTRABRAID PLUS SUTURE in the Repair of Tears of the Rotator Cuff

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

The primary objective of this study is to obtain safety data on the use of the ULTRABRAID PLUS SUTURE, and to assess the preliminary effectiveness of the use of the ULTRABRAID PLUS SUTURE in comparison to the ULTRABRAID SUTURE in patients undergoing rotator cuff 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: 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: NCT01562145 Completed - Rotator Cuff Tear Clinical Trials

Elevated Plasma Levels of TIMP-1 in Patients With Rotator Cuff Tear

Start date: January 2009
Phase: N/A
Study type: Observational

The aim of the study was to investigate the levels of matrixmetalloproteinases and their inhibitors in blood samples from patients with rotator cuff tears and compare with blood samples from healthy matched controls.

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: NCT01458665 Completed - Rotator Cuff Tear Clinical Trials

Arthroscopic Rotator Cuff Repair With Platelet-Rich Plasma (PRP) in Medium to Large Rotator Cuff Tears

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

- The purpose of this study is to compare the clinical and anatomical outcomes of rotator cuff repair with Platelet-Rich Plasma (PRP) and conventional rotator cuff repair in treatment of medium to large rotator cuff tears. - PRP application to arthroscopic rotator cuff repair would accelerate recovery after arthroscopic rotator cuff repair in terms of pain relief, functional outcomes, overall satisfaction, and enhance structural integrity of repaired tendon.

NCT ID: NCT01383239 Completed - Rotator Cuff Tear Clinical Trials

Impact of Postoperative Management on Outcomes and Healing of Rotator Cuff Repairs

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

Rotator cuff tears are seen in 40% of subjects over age 50 57, with a prevalence known to increase with each decade of life 51. Each year rotator cuff disorders lead to 4.5 million physician visits, 40,000 inpatient surgeries, and 250,000 outpatient surgeries with costs of $17,427 per patient in 2004. As the population ages, the number of rotator cuff repair surgeries is increasing; in New York State, rotator cuff repairs increased by 50% over a 5 years span 48. Unfortunately, surgically repaired rotator cuff tears fail in at least 20% and up to 94% of individuals 3, 9, 13, 20, 28, 40, 52, 58. While many non-modifiable variables have been associated with failure of repair, postoperative rehabilitation is a modifiable variable that has received little attention. The investigators propose a multicenter randomized controlled trial to study one important strategy for postoperative rehabilitation: early versus delayed onset of physical therapy. This pilot study will enroll patients with isolated supraspinatus tears who undergo a standard surgical repair technique. The investigators hypothesize that delaying the onset of physical therapy will improve healing and patient outcomes. Our primary outcome variable is the Western Ontario Rotator Cuff (WORC) Index (a disease specific validated outcome measure). Because outcome measures may not always correlate with healing of rotator cuff repairs 50, our secondary outcome measure will be healing based on MRI scans 12 months after surgery.

NCT ID: NCT01333527 Completed - Rotator Cuff Tear Clinical Trials

Early Mobilization Following Arthroscopic Rotator Cuff Repair

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

Shoulder rotator cuff (RC) tears are a significant cause of pain and disability. Surgery is done to reconnect the torn RC tendon(s) to the bone. The goals of RC surgery are to decrease pain, and to increase range of motion (ROM) and strength. This is done arthroscopically; through a small incision in the patient's shoulder. After surgery, patients are usually placed in a sling for up to 6 weeks to protect the repaired shoulder tendons. During this time, ROM exercises are only done by using the un-operated arm for assistance. Voluntary or active shoulder movement is usually not permitted to allow the repaired tendons to heal. Unfortunately, some patients develop shoulder stiffness while wearing the sling, which can delay rehabilitation. Any delays in rehabilitation may result in reduced shoulder function, a slower return-to-work or daily activities, and may also impact the health care system, through increased use and cost of rehabilitation. This study's purpose is to determine if patients can safely stop wearing their sling as early as pain and comfort allow following RC surgery. A total of 200 patients (100 per group) will be randomly assigned to one of two study groups: Patients in Group A (accelerated rehab) will wear their sling for comfort only following surgery. Self-assisted ROM exercises are allowed at any time. This means that patients may stop wearing their sling if pain and comfort allow, and start active movement for activities of daily living only. Patients in Group B (standard rehab) will wear their sling for 6 weeks. Like in group A, self-assisted ROM exercises are allowed at any time, but active movement will not be allowed until 6 weeks after surgery. Patients in both groups will be given the same self-assisted ROM exercises after surgery. Patients who agree to participate in the study will see their surgeon and the study physical therapist/research coordinator on 6 occasions (pre-surgery, 2 weeks, 6 weeks, 3, 6, 12 months post-surgery). Each visit will take about 30 minutes and will include a ROM assessment, strength assessment (as appropriate) and disease-specific quality of life questionnaires. Patients will also undergo an Ultrasound exam to verify that their RC repair is intact at 12-months. Differences in ROM, strength, questionnaire scores, RC integrity, and adverse events will be examined between the two groups. Differences will also be examined according to RC tear size and patient characteristics.