Treatment Trials

21 Clinical Trials for Various Conditions

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RECRUITING
Effect of BFR Rehab After Achilles Tendon Rupture
Description

The purpose of this study is to determine if blood flow restriction therapy after Achilles tendon rupture reconstruction decreases post-operative calf atrophy, improves reported outcomes, and ultimately decreases return to play time.

RECRUITING
NMES for Achilles Tendon Rupture
Description

The majority of patients suffering an Achilles tendon rupture develop long term functional deficits in the affected leg. The goal of the proposed study is to evaluate a new rehabilitation protocol using Neuromuscular Electrical Stimulation (NMES) for reducing muscle atrophy and improving tendon properties. If proven beneficial, the proposed protocol can be easily adopted and incorporated as part of routine care for Achilles tendon rupture.

WITHDRAWN
Use of Blood Flow Restriction Therapy in Perioperative Rehabilitation Following Achilles Tendon Rupture
Description

The purpose of this study is to examine the effect of utilizing blood flow restriction (BFR) therapy in the rehabilitation of Achilles tendon rupture (ATR). Muscle atrophy occurs following Achilles tendon rupture, whether managed non operatively or operatively, which has implications on patient outcomes. The goal of physical therapy in the perioperative period is to regain and ultimately return to activity. BFR has been proposed to reduce atrophy and maintain strength, which would theoretically mitigate the deconditioning effects of an injury on surrounding musculature. BFR is proposed to work by restricting arterial inflow leading to an oxygen depleted environment and the ability to induce muscle adaption at lower maximum repetition via reactive hyperemia and induction of growth cytokines, thus leading to muscle hypertrophy. The goal of this investigation is to determine if using BFR as an adjunct in physical therapy following ATR would reduce muscular atrophy and lead to increased and expedited strength gains. Additionally, the investigators would like to determine if BFR accelerates the rehabilitation process and allows patients to perform standard rehabilitative functional tests and return to play sooner. Furthermore, the investigators will investigate patient reported outcomes metrics. The investigators hypothesize that the BFR group will have significantly greater strength gains at all time points in both non operatively and operatively treated ATR. Previous studies have shown that BFR has potential in increasing Achilles tendon stiffness, tendon cross-sectional area, muscle strength and muscle hypertrophy. However, there is a lack of evidence regarding the use of BFR in both the pre and postoperative period specifically relating to ATR. The investigators believe that the use of BFR in the perioperative period surrounding an Achilles tendon rupture and ATR has the potential to significantly decreased muscle atrophy, improve patient satisfaction and lead to earlier return to sport.

TERMINATED
Surgical Treatment for Acute Patella Tendon Rupture
Description

We will compare two groups for acute patella tendon repair: one treated with surgical anchors and the second, with transpatellar tunnels.

COMPLETED
Use of Blood Flow Restriction (BFR) Therapy in Post-operative Rehabilitation Following Distal Biceps Tendon Repair
Description

The goal of this investigation is to determine if using BFR during postoperative therapy would lead to increased and expedited strength gains. Additionally, the investigators would like to determine if BFR is beneficial in preventing muscle atrophy and fatty infiltration in the setting of bicep tendon tears, due to the altered tension-length relationship following surgery. The study will also look at patient reported outcomes metrics and pain scores to determine if BFR has a significant impact on the patient experience surrounding distal biceps tear and surgical repair

ACTIVE_NOT_RECRUITING
Barriers to Efficient PACU Discharge at a Major Academic Orthopaedic Ambulatory Surgery Center
Description

This is a retrospective chart review to determine the etiologies contributing to prolonged PACU discharge at a major Orthopedic Ambulatory Center

COMPLETED
Achilles Tendon Lengthening With Traditional vs. Accelerated Rehab
Description

The purpose of this study is to evaluate the surgically repaired tendon of a ruptured achilles tendon. We will investigate fixation slippage and tendon creep and correlate how these post-repair findings can contribute to outcomes of tendon repairs.

COMPLETED
E-Stim and Achilles Tendon Repair Study
Description

Calf muscle atrophy (muscle degeneration) is common following Achilles tendon repair due to the immobilization period necessary to ensure optimal healing. The purpose of this study is to determine if the use of neuromuscular electrical stimulation (NMES) after Achilles tendon surgery will reduce calf muscle atrophy.

COMPLETED
Prospective Biceps Study
Description

The primary goal of this study is to determine if surgical repair of the distal biceps fully restores the supination strength of the forearm. Secondarily, the investigators want to examine the insertion site location of the tendon and determine if it correlates with the patients' functional outcome as determined by Disabilities of the Arm, Shoulder, and Hand (DASH), Visual Analog Pain Scale (VAPS), and isometric supination torque testing.

TERMINATED
Prospective Study on Artelon® Tissue Reinforcement in Repair of Chronic Ruptures and Re-ruptures of the Achilles Tendon
Description

The aim of this study is to evaluate the surgical and clinical outcome of Artelon® Tissue Reinforcement in repair of chronic ruptures or re-ruptures of the Achilles tendon, with regard to lower leg and foot function, pain and quality of life.

NOT_YET_RECRUITING
BFR After Biceps Tendon Repair and MPFLR
Description

The purpose of this study is to examine the effect of utilizing blood flow restriction (BFR) therapy after distal biceps tendon repair or medial patellofemoral ligament reconstruction (MPFLR) following a tear.

COMPLETED
Grappler Interference Screw Post-Market Collection of Patient Reported Outcome Measures
Description

Ambispective, multi-surgeon, single site, consecutive case series to determine the safety, performance, and benefits of the Grappler(R) Interference Screw.

COMPLETED
Effectiveness of Virtual Reality in Hand Therapy
Description

The purpose of this study is to determine if the use of Virtual Reality as an intervention for patients following specific hand injuries will positively affect patients with decreased hand function and reduce pain and improve outcomes. Participants will be recruited from 3 different clinics in central Kentucky.

RECRUITING
Quantitative and Clinical Assessment of Flexor Tendon Gliding Following Application of a Bioresorbable Hydrogel: A Prospective, Randomized Study in Patients Undergoing Distal Radius Fracture Repair
Description

The investigators will be evaluating the use of versawrap in the setting of distal radius fractures by placing membrane between plate and flexor tendons. Investigators will then evaluate tendon gliding morphology and number of tendon ruptures

COMPLETED
Grappler® Interference Screw Post-Market Clinical Follow-Up Study
Description

Ambispective, multi-surgeon, single site, consecutive case series to determine the safety, performance, and benefits of the Grappler(R) Interference Screw.

ENROLLING_BY_INVITATION
E-CEL UVEC Cells As an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in Adults
Description

This is a phase 1b investigator-initiated clinical trial that will evaluate the safety and feasibility of E-CEL UVEC® cells with the aim of improving outcomes for patients with full-thickness rotator cuff tears who undergo arthroscopic surgical repair. Allogeneic E-CEL UVEC cells will be delivered to the tendon repair site and to the muscle adjacent to the tendon repair site.

COMPLETED
Methylsulfonylmethane on Knee Laxity
Description

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.

WITHDRAWN
MRI Review of ACLR With and Without Lateral Extra-articular Tenodesis
Description

The purpose of the proposed study is to evaluate the effect of lateral extra-articular tenodesis (LET) on anterior cruciate ligament reconstruction through evaluation of postoperative magnetic resonance imaging (MRI). This will be a single-center non-randomized controlled study. The study is comparing postoperative graft MRI findings in two cohorts: patients undergoing isolated ACLR and patients undergoing ACLR with lateral extra-articular tenodesis (LET). Postoperative MRIs will be obtained at 6, 9 and 12 months postoperatively.

COMPLETED
Adductor Canal Block and IPACK Block vs. Isolated Adductor Canal Block for Post-Operative Analgesia Following ACL Reconstruction With Bone Patellar Tendon Bone Autograft:
Description

A randomized, single-blind, single-center study measuring the effects of adductor canal block combined with IPACK infiltration compared to adductor canal block alone on post-operative pain and opioid consumption in patients undergoing ACL reconstruction with Bone Patellar Tendon Bone Autograft

ACTIVE_NOT_RECRUITING
Tendon-Bone Versus All-Soft-Tissue for ACL Reconstruction: A Patient-Blinded Randomized Clinical Trial
Description

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.

COMPLETED
BioCleanse Tibialis Tendon Anterior Cruciate Ligament (ACL) Study
Description

To compare the outcome of Anterior Cruciate Ligament (ACL) reconstruction performed using the tibialis allograft to historical outcomes of ACL reconstruction patients and to establish if any correlation exists between the age of the graft donor and the clinical outcomes.