46 Clinical Trials for Various Conditions
To analyze outcomes between patients with Z2FT injuries following repair, randomized to two groups. The first group will be the negative control, with no tendon wrap. The second group will have a VersaWrap Tendon Protector applied over the site of the tendon repair. VersaWrap is current SOC at UF.
Flexor Tendon
Human clinical trial to measure the effect of long duration therapeutic ultrasound on tendon injuries. The hypothesis is that use of long duration ultrasound will relieve pain, increase tendon strength, and improve quality of life for patients with tendon injury.
Tendon Injuries, Musculoskeletal Pain
Platelet rich plasma has been used in previous studies to stimulate faster healing of torn ligaments and tendons in order to help reduce pain and restore normal function. This study aims to prove that non-operative treatment of acute and chronic ligament and tendon injuries with platelet rich plasma will reduce the time needed for participants to heal these injuries and restore function. We are currently enrolling patients with PATELLAR TENDON INJURIES in the KNEE.
Tendinopathy
The objective of this study is to assess whether recreational rock climbers experience thickening of the flexor digitorum tendon in the 2nd 3rd and 4th fingers. In these fingers the study will also assess whether there is thickening of the A2 annular pulley and if there is a measurable increase in the tendon to bone distance at the level of the A2 pulley when the fingers are placed into flexion against mild resistance. This study aims to provide clinicians with an understanding of how exposure to rock climbing can lead to chronic anatomical changes to the soft tissue structures of the finger. These changes have been demonstrated in the elite rock climber population, but have yet to be studied in the much larger and growing recreational rock climbing population which consisted of nearly 10 million participants in 2021. If significant, these anatomical variations might guide the assessment of imaging and clinical decision making when managing finger injuries in patients with exposure to rock climbing. Portable ultrasound probes will be used to scan and measure the dimensions of various soft tissue structures in the hands of both rock climbers and a control population, this data will be paired with data collected in a brief survey asking about exposure to rock climbing, history of finger injuries, and style of climbing.
Flexor Tendons Injuries
A multi-center, prospective post-market clinical follow-up study: subscapularis repair augmented with Tapestry Biointegrative Implant after shoulder arthroplasty. The primary objective of this study is to evaluate the long-term integrity of the subscapularis tendon repair after shoulder arthroplasty augmented with Tapestry Biointegrative Implant, assessed by ultrasound 6 months postoperatively. Secondary objectives are to assess shoulder function (internal rotation strength), safety, and patient reported outcomes. Patients will be evaluated preoperatively, at the time of surgery, 3, 6, 12 and 24 months after surgery.
Tendon Injuries- Subscapularis
The study will be looking at acute changes in Achilles tendon properties and changes in a vertical single leg hop following an exercise intervention. The three exercise interventions will be randomized and take place on separate days 1 week apart. The three exercise interventions are AAROM, slow load, and plyometrics.
Tendon Injuries
Blood flow restriction (BFR) therapy is a brief and partial restriction of venous outflow of an extremity during low load resistance exercises. It is a safe and effective method of improving strength in healthy and active individuals, recovering from orthopedic pathologies and procedures. This prospective, randomized study will look at the implications this form of treatment has on the rehabilitation of Achilles injuries.
Achilles Injuries Tendon
The purpose of this study is to investigate whether providing patients with a question prompt list (QPL) prior to their orthopaedic surgery clinic appointment improves their perceived involvement in care (PICs) score compared to being given 3 questions from the AskShareKnow model
Tendon Injuries, Fracture, Arthritis, Sprains, Strains, Tumor, Pain
The purpose of this study is to evaluate the use of NuShield in subjects requiring surgical tendon repair.
Tendon Injuries, Tendinopathy
Conflicting evidence exists regarding the recommendations from the Orthopaedic section of the American Physical Therapy Association for treatment of Achilles tendinitis. Trigger point dry needling is effective in reducing pain in several body regions, but no published (TDN) studies are found reporting the effect on Achilles tendinopathy. The purpose of this study is to investigate whether a treatment program performed including TDN, manual therapy and exercise will result in a significant improvement in pain, strength and function compared to a treatment program including manual therapy and exercise for Achilles tendinopathy. Subjects with Achilles tendinopathy that receive treatment including TDN, manual therapy and exercise will demonstrate a significant improvement in pain, strength and functional outcomes compared to the group that receives manual therapy and exercise.
Achilles Tendon Injury
As per non-clinical studies, prolyl hydroxylase inhibitor GSK1278863 can protect muscle from unaccustomed exercise induced muscle damage and enhance functional muscle repair. This study is designed to investigate arm function, pain and other pharmacodynamic (PD) markers after unaccustomed maximal eccentric exercise with concurrent administration of GSK1278863 or placebo. Primary objective of the study is to evaluate the protective effects of GSK1278863 on eccentric exercise induced muscle injury. Subjects will be randomized in a 1:1 ratio (1 subject on GSK1278863 for every 1 subject on placebo). Each subject will be given five oral doses of GSK1278863/placebo in total. The first dose will be administered immediately after completion of eccentric exercise and then 4, 8, 24, and 48 hours later. Subjects will be housed till day 4 in unit and will return for a follow-up visit 7-10 days after discharge. After enrolment of approximately 30 subjects, enrolment will be paused and planned interim analysis will be performed to decide whether to terminate enrolment/study, continue dosing or to reduce the dose to 5 milligrams (mg).
Tendon Injuries
This clinical trial aims to determine the effects of a 6-day low-dose methylprednisolone course on pain, nausea, and total opioid consumption in patients undergoing foot and ankle surgeries. The secondary objective of the study is to determine and monitor the effects of the course on complications following surgery and patient-reported outcomes
Foot Injuries and Disorders, Ankle Injuries and Disorders, Achilles Tendon Injury
This is a prospective, single-center study design with enrollment of 15 subjects. The 15 subjects will all undergo standard gluteus medius repair that includes augmentation with the biointegrative implant. This is a small observational study. As such, we expect that the results from 15 subjects will give an adequate understanding of post surgical healing.
Hip Injuries, Tendon Injuries, Orthopedic Procedures
The purpose of this study is to evaluate continuous ultrasound treatment with diclofenac coupling patch during routine care of musculoskeletal injuries which failed conservative treatment to better understand clinical utilization of the treatment on types of injuries, how the treatment helps patients (pain, function and quality of life), and information on healthcare provider ordering the therapy and general workflow. Low-intensity continuous ultrasound (LICUS) is a bio regenerative technology used when normal rehabilitation is insufficient, applied with a wearable device (SAM, Zetroz Systems LLC) for daily use. The treatment provides long-duration ultrasound for approximately four hours. The objective of this study is to examine the real-world outcome data on symptoms improvement and return to function using SAM during routine care.
Musculoskeletal Injury, Pain, Chronic, Pain, Acute, Sport Injury, Soft Tissue Injuries, Arm Injury, Back Pain, Tendon Injuries, Muscle Injury
The proposed research will focus on determining the effect of methylsulfonylmethane (MSM) on knee laxity changes through the menstrual cycle in young active females. As an extension to recent discovery, that MSM reverses the negative effect of estrogen on engineered ligament function, the proposed work is designed to determine whether MSM can decrease the negative effect of estrogen on knee laxity in females. Ligament function is determined by the content and cross-linking of collagen, which is influenced by a milieu of biochemical and mechanical parameters. The greater the amount and cross-linking the greater the stiffness and strength of these connective tissues. In engineered ligaments it has been previously shown that the high levels of estrogen, normally present in the days before and after ovulation, can inhibit the cross-linking enzyme lysyl oxidase. This decrease in collagen cross-linking likely increases connective tissue laxity and contributes to observed 4-fold greater occurrence of anterior cruciate ligament (ACL) rupture in females. Conversely, MSM increases collagen cross-linking and recent work conducted by the Baar lab in engineered human ligaments treated with high estrogen demonstrated that MSM could completely reverse the effects of estrogen on ligament mechanics. The proposed research aims to advance this promising pre-clinical data and apply in a clinical trial. This research also proposes to quantify that knee laxity increases up to 5mm between the first day of menstruation and the day after ovulation and also that the magnitude of the increase in laxity is directly related to the magnitude of the change in estrogen. Importantly, a direct relationship between knee laxity and ACL rupture exists. For every 1.3mm increase in anterior-posterior knee displacement, the odds of ACL rupture increase 4-fold. Therefore, any treatment that decreases knee laxity could be expected to reduce ACL ruptures and have widespread application across the general active population and high-level athletics.
Ligament Injury, Ligament; Laxity, Tendon Rupture, Tendon Injuries
This study is a prospective, single center, postmarket study to evaluate the safety and effectiveness of NeoPatch used as a tissue cover in foot and ankle tendon revision and repair surgery.
Tendinopathy, Tendon Tear, Tendon Injuries, Foot Ankle Injuries
Determine if volume imaging can diagnose bone, ligament, muscle injuries.
Bone Injuries, Muscle Injuries, Tendon Injuries
The objective of the study is to assess mechanical strength and function in subjects undergoing Musculotendinous Tissue Unit Repair and Reinforcement (MTURR) with the use of biologic scaffolds for the restoration of both mechanical strength and function in these subjects. This study will formally evaluate healing and return of function after an extracellular matrix device implantation in 40 male and female subjects participating at 4-5 military sites who suffer from injury with loss of skeletal muscle tissue. The University of Pittsburgh under the Department of Plastic and Reconstructive Surgery is the Coordinating Center for this multi-site study.
Traumatic Injury, Muscle Injury, Tendon Injury, Soft Tissue Injury, Extremity Injury
The objective of the study is to assess mechanical strength and function in subjects undergoing Musculotendinous Tissue Unit Repair and Reinforcement (MTURR) with the use of biologic scaffolds for the restoration of both mechanical strength and function in these subjects. This study formally evaluated healing and return of function after an extracellular matrix device implantation in 17 male and female subjects participating at the University of Pittsburgh under the Department of Plastic and Reconstructive Surgery who suffer from injury with loss of skeletal muscle tissue.
Traumatic Injury, Muscle Injury, Tendon Injury, Soft Tissue Injury, Extremity Injury
Hypothesis: The use of cascade platelet-rich fibrin matrix (PRFM) on medium and large sized rotator cuff tears will improve patient results versus the control results by 50%. The purpose of this study is to examine the effect of PRFM on rotator cuff repairs. Since locally applied platelet-derived growth factor (PDGF) has shown early promise in enhancing tendon and ligament healing in anterior cruciate ligament (ACL) and medial collateral ligament (MCL) reconstruction, the investigators believe that locally applied PRFM will enhance the quality of rotator cuff repairs.
Rotator Cuff, Tendon Injuries
Posterior tibial tendon dysfunction (PTTD) is a problem with the tendon connecting one of the lower leg muscles to the foot bone. PTTD can cause pain, swelling, and a flattened foot and may require surgery if left untreated. Normal treatment for PTTD includes physical therapy exercise. In treating similar conditions in the lower leg, exercises that are active, like strengthening, seem to have better results than exercises that are passive, like stretching. This study will determine whether adding strengthening exercises to a normal PTTD treatment that includes wearing a brace and stretching is more beneficial than just wearing a brace and stretching.
Posterior Tibial Tendon Dysfunction
The purpose of this study is to evaluate the effect of a ketoprofen topical patch on the pain associated with tendonitis or bursitis of the shoulder, elbow or knee
Tendonitis, Bursitis
The purpose of this study is to evaluate the effect of a ketoprofen topical patch on the pain associated with tendonitis or bursitis of the shoulder, elbow or knee.
Tendonitis, Bursitis
This study is attempting to understand whether or not splinting after a fingertip injury improves recovery.
Injury Distal to Flexor and Extensor Tendon Insertions
Reverse total shoulder arthroplasty (RTSA) can reliably restore active forward elevation, abduction, and external rotation, which are often lost in patients with massive rotator cuff tears. However, functional internal rotation (i.e., functional movements of the hand behind the body) is often unsatisfactorily restored and/or lost after RTSA. This study aims to compare the standard surgical approach for RTSA to RTSA with conjoint tendon resection with the targeted metric being postoperative functional internal rotation.
Shoulder Injuries, Patient Satisfaction, Internal Rotation Contracture-shoulder
The choice of autograft for ACL reconstruction continues to be debated. To date, there has only be one completed randomized controlled trial with quad tendon to BTB and the tendon included a bone plug. There has been no study to date comparing an all soft tissue quad tendon to patellar tendon in a randomized controlled trial for ACL reconstruction.
Orthopedic Disorder, Anterior Cruciate Ligament Injuries
It is estimated that 48 out of 10,000 people, in the United States, will tear their anterior cruciate ligament (ACL) annually and undergo ACL reconstruction (ACLR). Surgeons have several graft options, surgical techniques, and fixation methods to consider when planning how to reconstruct a patient's ACL. Graft options vary greatly and include allografts and autografts with good evidence that are good choices. Further, autografts include several different specific grafts including; bone-patellar tendon-bone (BPTB), hamstring tendons, and quadriceps tendon. There is no clear consensus on which graft type is superior, as each graft has associated positives and negatives. Historically, autologous BPTB grafts have been the preferred choice of surgeons given its ability to restore rotational stability for the knee, the robust healing with direct bone-to-bone contact at both ends of the graft, and low failure rates. However, there are drawbacks to ACLR using a BPTB graft. Complications following BPTB graft harvesting include patella fractures, patellar tendon ruptures, increased risk of patellofemoral osteoarthritis, lack of terminal extension, and donor-site morbidity. The majority of these complications are associated with low-risk rates, except for donor-site morbidity which may be prevalent in 37-51% of BPTB graft patients. Donor-site pain can manifest as anterior knee, patellofemoral pain, loss of sensory input, or discomfort with kneeling and can negatively influence subjective as well as objective measures of knee function. Filling bony defects with bone graft is a procedure that is commonly conducted within orthopedics. However, its use in treating the bony defects caused during BPTB graft harvesting is less common as patella and tibial harvest sites are routinely left unfilled. Significant methodological differences in treatment interventions for the patella harvest site, the tibial harvest site, or both and conflicting results have made it difficult to determine if these treatments have clinical utility. To the best of the investigators' knowledge, there has been no investigation looking at the incidence of donor site morbidity treated with autologous bone grafting of the harvest sites. Therefore, the purpose of this study is to determine if filling the harvest site defect is associated with a lower rate of donor site morbidity and better patient reported functional outcomes compared to patients whose harvest site remains unfilled. The purpose of this study is to compare the rate of donor site morbidity between patients who have their harvest sites bone grafted with autologous bone (BG) and those whose harvest sites remain unfilled (nBG).
ACL Injury
The overall objective of the proposed research is to conduct a prospective, randomized controlled trial to investigate whether the addition of BFR therapy to standard post-operative rehabilitation regimen significantly improves clinical outcomes following anterior cruciate ligament reconstruction (ACLR) standardized with respect to both surgical technique and graft selection. Patients indicated for ACLR will be screened and offered enrollment into this prospective, randomized controlled trial. MRI of bilateral thighs will be performed within 7 days of ACLR. Patients will be randomized to either REHAB or REHAB + BFR (study intervention) using a block randomization scheme. Patients will undergo repeat MRI of bilateral thighs pre-surgery, at 12 weeks, and at 52 weeks post-operatively (primary outcome measure.) Patient reported outcome (PRO) instruments will be administered pre-operatively to establish pre-operative debility related to ACL injury and subsequently after ACLR at 24 weeks, 36 weeks, and 52 weeks post-operative (secondary outcome measures).
ACL Injury
In primary pediatric Anterior cruciate ligament (ACL) reconstruction, the quadriceps tendon with either tendon and patellar bone or an all-tendon graft is commonly employed. However, no randomized control trial has sought to discern the superior graft option in regards to both short-term and long-term patient outcomes.The purpose of this study is to assess the differences between these two widely used surgical techniques in ACL reconstruction by examining short, intermediate, and long term outcomes of both approaches.
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Tear
Anterior cruciate ligament (ACL) rupture is one of the most common musculoskeletal injuries in young individuals, particularly those that are active in sports. Up to 30% of individuals under the age of 20 years suffer a re-injury to the reconstructed ACL. Revision ACLR has been associated with degeneration of the articular cartilage and increased rates of meniscal tears, increasing the risk of post-traumatic osteoarthritis (PTOA), additional surgical procedures, reduced physical function and quality of life. As such, strategies to reduce ACLR failure, particularly in young active individuals, are critical to improving short and long-term outcomes after ACL rupture. There is ongoing debate about the optimal graft choice and reconstructive technique. Three autograft options are commonly used, including the bone-patellar-tendon-bone (BPTB), quadriceps tendon (QT) and hamstring tendon (HT). Additionally, a lateral extra-articular tenodesis (LET) may provide greater stability to the ACLR; however, its effect on failure rate is unclear and surgery-induced lateral compartment OA is a concern. To definitively inform the choice of autograft and the need for a LET, this multicenter, international randomized clinical trial will randomly assign 1236 young, active patients at high risk of re-injury to undergo ACLR using BPTB or QT autograft with our without LET.
Anterior Cruciate Ligament Injury, Anterior Cruciate Ligament Reconstruction, Joint Instability