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Rotator Cuff Tears 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: NCT05894265 Not yet recruiting - Rotator Cuff Tears Clinical Trials

Prospective Study to Determine the Safety and Effectiveness of a Connective Tissue Allograft Active Matrix (AM) vs. Standard of Care in Arthroscopic Rotator Cuff Repair

Start date: June 5, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to see how well the ActiveMatrix® graft works at improving healing and function of the shoulder following rotator cuff repair surgery

NCT ID: NCT05852093 Not yet recruiting - Rotator Cuff Tears Clinical Trials

Clinical Study on the Effect of Tizanidine on the Function and Pain of Patients After Shoulder Arthroscopy

Start date: June 1, 2023
Phase: Early Phase 1
Study type: Interventional

The perspective, randomized controlled trial is to investigate and evaluate the effect of Tizanidine on the function and pain of patients with rotator cuff tear after shoulder arthroscopy;

NCT ID: NCT05817578 Not yet recruiting - Rotator Cuff Tears Clinical Trials

Profiling the RCRSP Patient: a Pain Phenotype Classification Algorithm

Start date: September 2, 2023
Phase:
Study type: Observational

The aim of this study is to collect a sum of different characteristics that have been mentioned previously in people presenting with RCRSP and by clustering them to create a phenotype system which may assist the individualisation of their management

NCT ID: NCT05800847 Not yet recruiting - Rotator Cuff Tears Clinical Trials

Effect of Gabapentin on Sleep and Opioid Use Following Rotator Cuff Repair

Start date: April 2023
Phase: Phase 4
Study type: Interventional

The goal of this clinical trial is to compare the effects of gabapentin in patients undergoing rotator cuff repair surgery. The main question it aims to answer is whether gabapentin can improve postoperative pain and sleep quality. Participants in this study will be randomized to either take gabapentin after surgery or a placebo after surgery.

NCT ID: NCT05788250 Not yet recruiting - Rotator Cuff Tears Clinical Trials

RC Repair Versus Subacromial Balloon Spacer in Older Adults

Start date: August 2024
Phase: N/A
Study type: Interventional

The purpose of this pilot study is to assess the feasibility of a full randomized trial design.

NCT ID: NCT05670080 Not yet recruiting - Shoulder Pain Clinical Trials

Does MI Have a Therapeutic Role in Arthroscopic Rotator Cuff Repair?

Start date: September 15, 2025
Phase: N/A
Study type: Interventional

Objective: The aim of this study is to investigate the effect of motor imagery on muscle activity, pain, and function in arthroscopic rotator cuff repair. Methods: As a result of the power analysis (G-Power), 36 participants are planned to be included in this study Block randomization will be used to divide participants into 2 groups, each with at least 18 participants: Group 1 (MI group) and Group 2 (Control group) (Randomizer.org). Both groups will receive a 4-week physical therapy program. MI (Motor Imagination) group will receive a motor imagination program in addition to the physical therapy program. Data will collect using the visual analog scale (VAS), goniometric measurement, circumference measurement, Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH), Kinesthetic and Visual Imagery Questionnaire- KVIQ-20, Tampa Kinesiophobia Scale, 3-question satisfaction questionnaire, superficial Electromyography (EMG) (BTS Bioengineering Free EMG 100 RT). Practice Implications: The current study will contribute to understanding how motor imagination affects muscle activity and muscle atrophy.

NCT ID: NCT05484271 Not yet recruiting - Rotator Cuff Tears Clinical Trials

Relationship Between the Arthroscopic Anatomy of the Middle Glenohumeral Ligament and the Rotator Cuff Tear Position

Start date: August 5, 2022
Phase:
Study type: Observational

The main aim and scope of this study is making observation and comparing the difference in the tear position in the patients suffered form rotator cuff tear with different arthroscopic anatomy of the middle glenohumeral ligament. The results may identify the influence of the middle glenohumeral ligament anatomy type on the rotator cuff tear.

NCT ID: NCT05477771 Not yet recruiting - Rotator Cuff Tears Clinical Trials

The Cross-sectional Area of the Long Head of the Biceps Tendon and the Rotator Cuff Tear Position

Start date: July 29, 2022
Phase: N/A
Study type: Interventional

The main aim and scope of this study is making measurement and comparison of the cross-sectional area of the long head of the biceps tendon(LHBT) in the patients suffered form rotator cuff tear with different tear positions, and making observation and comparison of the impairment type of the LHBT in the patients suffered from rotator cuff tear with different tear positions. The results may identify the influence of the tear position on the LHBT.

NCT ID: NCT05009498 Not yet recruiting - Clinical trials for Vitamin D Deficiency

Vitamin D3 Supplementation for Vitamin D Deficiency in Rotator Cuff Repair Surgery

Start date: September 1, 2021
Phase: N/A
Study type: Interventional

Rotator cuff injuries are the most common cause of shoulder disability and is increasingly more prevalent in the aging population. Rotator cuff repair has long been the mainstay of treatment for symptomatic full-thickness tears and medium to large partial thickness tears that do no improve with nonoperative therapies. Approximately 32% of the US population is Vitamin D deficient. This is important for many health reasons, but specifically, Vitamin D has been found to play a critical role in bone mineralization and fracture healing/prevention. There is emerging data to support Vitamin D's role in regulating the inflammatory response throughout the body, which includes soft tissue (i.e. tendons) healing. The role of Vitamin D in tendon to bone healing has yet to be fully investigated, yet it is reasonable to conclude that normal blood levels of Vitamin D would optimize the setting for healing in rotator cuff repair. The investigators hypothesize that Vitamin D deficient patients undergoing shoulder rotator cuff repair will experience more positive outcomes and decreased complications when supplemented with Vitamin D3, compared to Vitamin D deficient patients who do not receive supplementation. The objective of this study is to demonstrate the positive effect of Vitamin D3 in rotator cuff repair healing and patient reported outcomes in patients who are Vitamin D deficient