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Rotator Cuff Tear clinical trials

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NCT ID: NCT05906004 Not yet recruiting - Rotator Cuff Tears Clinical Trials

Retrospective Data Collection and Prospective Clinical Investigation for the Augmentation or Reinforcement of the Rotator Cuff Using the Pitch-Patch

Start date: November 2024
Phase:
Study type: Observational [Patient Registry]

This is a clinical investigation study. It will verify the long-term safety and performance of the Pitch-Patch when implanted to reinforce partially repairable rotator cuff tears and used as described by the manufacturer's instructions. The medical device in this study is already on the market and is manufactured by Xiros Ltd. The Pitch-Patch is a single-use polyester prosthesis available in two sizes (30x20mm and 35x25mm). It is reinforced around the perimeter and around each eyelet to provide strength and stability to the device and repair. The study will collect data on patients who meet the entry criteria and have received the device. This is a single-armed study, meaning all patients will have a Pitch-Patch. The total length of the is expected to be 4 years; this includes a recruitment period of 2 years, and a follow-up period (for the prospective clinical investigation) of 2 years. A minimum of 32 patients will be enrolled into the study. Follow-up data will be collected at (if available for retrospective data) 3 months, 6 months, 1 year, 2 years and final follow-up (maximum 2.5 years for prospective study; maximum of 5 years for retrospective study).

NCT ID: NCT03738735 Not yet recruiting - Rotator Cuff Tear Clinical Trials

Randomized, Controlled Trial of Hyperosmotlar Saline for Rotator Cuff Repair Irrigation Solution

Start date: January 2019
Phase: Phase 4
Study type: Interventional

The goal of this project is to perform a randomized, double-blinded study investigating postoperative pain after arthroscopic rotator cuff using hyperosmolar saline as opposed to lactated ringer's solution (normal osmolarity) as arthroscopy irrigation solutions. Hyperosmolar saline is an irrigation solution with a higher concentration of solutes that will be used intraoperatively to washout the surgical field. It will be used in place of lactated ringer's solution, which has an osmolarity comparable to that of normal saline. This study will help determine whether or not postoperative pain from rotator cuff repair can be mitigated by altering the osmolarity of the intraoperative irrigation solution. This knowledge is significant because the postoperative pain can be intense, so much so that patients may depend on narcotics for pain relief. Consequently, this study may provide benefit by helping to find new ways to minimize the need for narcotics. The main hypothesis of this is study is that hyperosmolar saline will reduce perceived pain and narcotic use in the postoperative period.

NCT ID: NCT03616340 Not yet recruiting - Rotator Cuff Tear Clinical Trials

Efficacy of Intra-articular NSAID Versus Corticosteroid in the Treatment of Shoulder and Knee Conditions: A Randomized, Double-Blind, Prospective Study

Start date: August 2018
Phase: Phase 3
Study type: Interventional

The proposed study will compare the efficacy of Triamcinolone versus Ketorolac for intra-articular injection of the knee and shoulder

NCT ID: NCT03358316 Not yet recruiting - Rotator Cuff Tear Clinical Trials

Correlation Analysis Between Rotator Cuff Tear and the Superior Migration of Humeral Head

Start date: January 1, 2018
Phase: N/A
Study type: Observational

To evaluate the association between rotator cuff tear and the proximal migration of humeral head

NCT ID: NCT03300531 Not yet recruiting - Rotator Cuff Tear Clinical Trials

Impact of Autologous Pure Platelet-rich Plasma in the Treatment of Tendon Disease

Start date: December 1, 2017
Phase: Phase 2
Study type: Interventional

This is a randomized parallel controlled double-blind phase 2 clinical study.All subjects are recruited from the patients of rotator cuff tear, lateral epicondylitis or chronic achilles tendonitis. Patients will be randomly divided into three groups. Autologous pure platlet-rich plasma (P-PRP) and platlet-rich plasma (PRP) are purified from the peripheral blood .Patients of case groups will receive P-PRP or PRP injection once a week for three times while the control group received the same dose compound betamethasone injection. Follow up visit will occur at 1 month,3 months, 6 months,12 months after the last injection. Clinical quantitative assessment will measure by the visual analogue scale(VAS). The secondary outcomes are the constant-murley score(CMS) and the rating scale of the American shoulder and elbow surgeons(ASES) and the disability of arm shoulder and hand(DASH). The objective evaluation methods is that the examination of MRI or ultrasound were accomplished before the first injection and at 6 and 12 months afterwards.

NCT ID: NCT03279796 Not yet recruiting - Rotator Cuff Tear Clinical Trials

Treatment of Tendon Disease Using Autologous Adipose-derived Mesenchymal Stem Cells

Start date: October 1, 2018
Phase: Phase 2
Study type: Interventional

This study was a single-center, randomized, single-blind clinical trial. We plan to include 100 patients who met exclusion criteria of rotator cuff and lateral epicondylosis (tennis elbow) respectively by MRT or ultrasonography. The patients will be randomly divided into two groups. Adipose mesenchymal stem cells will be isolated from adipose tissue, cultured and then transplanted back to the tendon injury site by multiple point injection. 1*10^6 cells as an unit. Patients in the experiment group will be injected into an unit of adipose mesenchymal stem cells (1*10^6/10kg) while the control group received the same dose compound betamethasone injection. Follow up visit for all patients will occur at 1,3,6 and 12 months after the first injection. Clinical quantitative assessment will measure by the visual analogue scale(VAS). The secondary outcomes are the constant-murley score(CMS) and the rating scale of the American shoulder and elbow surgeons(ASES) and the disability of arm shoulder and hand(DASH). The objective evaluation methods is that the examination of MRI or ultrasound were accomplished before the first injection and at 6 and 12 months afterwards.

NCT ID: NCT03060928 Not yet recruiting - Rotator Cuff Tear Clinical Trials

Evaluation of Tendon-to-Bone Healing Potential in Arthroscopic Rotator Cuff Repair Through Biological Stimulation

Start date: March 1, 2017
Phase: N/A
Study type: Interventional

Evaluation of clinical and radiological outcomes in patients undergoing Arthroscopic Rotator Cuff Repair with standard treatment compared to patients receiving biological stimulation with micro-perforations or with the combination of micro-perforations and use of Artelon® Tissue Reinforcement, a synthetic device based on degradable polyurethaneurea. The investigators believe that this kind of tendon-to-bone healing stimulation with the two proposed methods can increase the repair quality by significantly decreasing the lesion recurrence rate (currently described for 15% of patients) and can improve various parameters such as pain, range of motion and strength, thereby hastening the return to daily activities and psycho-physical well-being.

NCT ID: NCT01498198 Not yet recruiting - Rotator Cuff Tear Clinical Trials

Workers Compensation Board: Rotator Cuff Tear Management

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

The overall goal of this proposed randomized study is to determine if surgery at the time of diagnosis or rehabilitation +/- surgery (i.e. surgery only when rehabilitation fails) results in shorter times to claim closure. The study will examine how often non-operative management is successful in resolving symptoms and allowing subjects to return to work without surgery. The investigators will also examine if there are subject, tear or work-related characteristics that affect the outcome of rehabilitation or expedited surgery and predict whether patients should be referred to operative or non-operative management at time of assessment. At study completion, the investigators expect to be able to definitively state the best management for subjects with these less serious RC tears. The specific research questions to be addressed are as follows: 1. In WCB subjects with high grade partial thickness (>50%) or small full thickness (≤ 1 cm.) rotator cuff tears, how does non-operative management (i.e. rehabilitation) or expedited surgery affect time to claim closure? 2. Are there subject, tear or work-related characteristics that affect which patient management approach will be most effective and efficient?

NCT ID: NCT01242761 Not yet recruiting - Rotator Cuff Tear Clinical Trials

Ultrasound as a Diagnostic Tool for Rotator Cuff Tears

Start date: January 2011
Phase: N/A
Study type: Observational

After comparing ultrasound study of rotator cuff injuries that have been evaluated both in the community and in a hospital-based ultrasound service with actual surgical findings, it is expected that specialist performed imaging and evaluation will be most accurate and that those performed in the community will be not accurate enough.