Clinical Research Directory

Tourniquet Vs. No-Tourniquet Technique in Total Knee Arthroplasty at the University Hospital of the West Indies

The goal of this clinical trial is to determine whether performing total knee replacement surgery (total knee arthroplasty, TKA) without a tourniquet is clinically equivalent to performing the procedure with a tourniquet in adults with symptomatic knee osteoarthritis. A tourniquet is commonly used during surgery to reduce bleeding and improve the surgeon's view. However, some studies suggest it may be associated with certain complications. It is currently unclear whether using a tourniquet meaningfully changes outcomes compared to not using one. This study aims to assess whether both approaches result in similar outcomes within a clinically acceptable range. The main question this study aims to answer is: Is total blood loss during surgery equivalent between TKA performed with a tourniquet and TKA performed without a tourniquet, within a predefined margin of ±100 mL? Additional questions include: Are surgical field quality, postoperative pain, functional recovery, and complication rates comparable between the two techniques? Researchers will compare: TKA performed with a pneumatic tourniquet TKA performed without a tourniquet to determine whether outcomes between the two approaches are equivalent rather than whether one is superior to the other. Participants will: Be randomly assigned to one of the two surgical groups using a computer-generated process Undergo standard total knee replacement surgery and routine perioperative care Have blood loss assessed during and after surgery Be monitored for pain, recovery of function, wound healing, and complications during hospital stay and follow-up visits This study is designed as a randomized controlled equivalence trial to determine whether both surgical approaches produce comparable outcomes within clinically acceptable limits, in a standardized local setting.

Cross-Education From Unilateral Strength and Balance Training in Older Adults With Bilateral Knee Osteoarthritis

Kinesitherapy is one of the main tools in the rehabilitation of knee osteoarthritis, but is often limited due to pain, reduced functionality, and fear of falling in older adults. This study will, through three sub-studies, examine the effects of unilateral training programs on strength, movement control, balance, and pain in the contralateral leg, as well as on functionality, fall risk, and kinesiophobia in older adults with bilateral knee osteoarthritis through three sub-studies. A total of 45 participants (aged 60-80 years) with bilateral knee osteoarthritis will be randomly assigned to one of three groups: 1. combined unilateral strength and balance training; 2. unilateral balance training; 3. unilateral strength training. Strength will be measured with maximal voluntary contraction, balance using a single leg stance test on an unstable surface, movement control with an active joint position reproduction test, and functionality using the six-minute walk test and the Western Ontario and McMaster Osteoarthritis Index questionnaire. Pain will be assessed with the Visual Analog Scale and the Intermittent and Constant Osteoarthritis Pain questionnaire, fall risk with the Timed Up and Go test and the Falls Efficacy Scale-International questionnaire, and kinesiophobia using the TAMPA questionnaire. This study will expand knowledge on cross-transfer and its effects on symptoms in the rehabilitation of older adults with bilateral knee osteoarthritis. This research is a part of a doctoral thesis conducted under the supervision of assoc. prof. Tatjana Trošt, PhD.

A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Knee Osteoarthritis Lose Weight and Reduce Pain

The purpose of this clinical study is to find out if NNC0487-0111 is safe and effective for treating people who have excess body weight and knee osteoarthritis. There are 2 study treatments in this study taken as injections under the skin once a week. Participants will either get NNC0487-0111 (the treatment being tested) or Placebo (a treatment that has no active medicine in it). Which treatment participants get is decided by chance.

Altered Joint Mechanics and Biological Response in Osteoarthritic Knees.

Osteoarthritis (OA) stands out as the most prevalent joint disease. It manifests as a progressive degradation of articular cartilage, new bone growth and often synovial tissue proliferation, resulting in pain and compromised joint functionality, ultimately leading to disability. Misalignment of the lower limb (varus or valgus knees) are recognised as a risk factor for osteoarthritis onset and progression. High tibial osteotomy (HTO) is a surgical technique that allows to shift the load from the affected area to other areas with intact cartilage. Similarly to HTO, braces realign the lower limb, without the need for surgical intervention. These corrective treatments are recommended for the youngest group of patients as it allows them to stay active, as opposed to Total Knee Replacement (TKR). Until today, the effects of braces and HTO on the subchondral bone microstructure and cartilage are not well understood. Investigating these aspects to better understand treatment failures is becoming more and more crucial because global prevalence of knee OA is expected to increase with the ageing of populations.

PROPRIOCEPTION, KINESIOPHOBIA AND FUNCTIONAL RECOVERY AFTER GONARTHROSIS SURGERY

This observational study aims to investigate the relationships between proprioception, causes of kinesiophobia, sensory processing characteristics, and functional recovery in individuals undergoing gonarthrosis surgery. Postoperative functional recovery can be influenced by sensorimotor and psychological factors such as impaired proprioception, fear of movement, and changes in sensory processing. However, the interaction between these factors has not been sufficiently clarified. Participants will complete a sociodemographic and clinical information form, the Western Ontario and McMaster University Osteoarthritis Index (WOMAC), the Causes of Kinesiophobia Scale, and the Adolescent/Adult Sensory Profile. Proprioception will be assessed using the Joint Position Perception Test.

Recombinant Human Growth Hormone (rHGH) for Knee Osteoarthritis (KORR)

The goal of this clinical trial is to see if people with knee osteoarthritis would be willing to comply and adhere to incorporating Recombinant Human Growth Hormone (rHGH), specifically Saizen Somatropin solution, into their treatment plan. Participants will be asked to: * Self-inject the treatment solution (placebo or somatropin) into the abdominal or gluteal area once per day for a total of 6 weeks. * Complete questionnaires related to their knee pain and activities of daily living. * Provide blood tests. * Complete various measurements including: circumference of thigh, calf, and abdomen; strength of thigh and knee; range of motion of both knees; and gait analysis.

Individual Differences in Gait and Osteoarthritis Pain

The goal of this observational study is to look at inter-individual differences in knee osteoarthritis (OA) walking pain and performance. The main questions this study aims to answer are: Why do some people with knee osteoarthritis have more severe disabling pain than others, even though the degenerative changes in their knees are similar? What are the factors that contribute to walking pain in people with knee osteoarthritis? Participants will complete surveys, perform physical function tasks, get a knee X-ray and MRI, undergo non-invasive brain imaging, and undergo sensory testing.

A Clinical Study to Evaluate the Efficacy of Native CT-II® in Individuals With Knee Osteoarthritis

This randomized, double-blind, placebo-controlled clinical study evaluates the efficacy of Native CT-II® (undenatured type II collagen) in individuals with knee osteoarthritis using a parallel design.Participants are assigned to one of three groups: Group 1 receives Native CT-II® (40 mg daily individed doses), Group 2 receives Glucosamine HCL + Chondroitin Sulphate (2700 mg daily as acomparator), and Group 3 receives a placebo (Microcrystalline Cellulose). All participants take threecapsules after breakfast and three after dinner for 90 days . The study aims to screen approximately 142 participants , randomizing around 114 (considering a 20% dropout rate), with a target of 90completed participants (30 per group). Osteoarthritis (OA) is a degenerative joint disorder causing pain, stiffness, and reduced mobility,primarily affecting older adults. It is a leading cause of disability, with knee OA being the mostprevalent form. The global burden of OA is rising due to aging populations and increasing obesityrates, necessitating improved treatment options. Current management focuses on symptom reliefthrough non-pharmacological (exercise, weight loss) and pharmacological (NSAIDs, analgesics)interventions, though these can have adverse effects. Undenatured type II collagen (NCTII), derived from chicken sternum, has emerged as a potentialsupplement for joint health. It triggers an immune response that reduces inflammation and supportscartilage repair. Clinical studies show that NCTII improves joint function, pain, and quality of life,outperforming glucosamine and chondroitin with fewer side effects. A new study aims to evaluatethe efficacy of Native CT-II® in individuals with Grade II and III knee OA over 90 days, comparing itto glucosamine-chondroitin and placebo groups.

The Effect and Safety of Anti-inflammatories and Dextrose Prolotherapy Injections in Treating Knee Osteoarthritis

Our purpose is to expand upon the results of the pilot study performed at David Grant Medical Center (DGMC) which showed that concomitant non-steroidal NSAID use in adults with knee osteoarthritis (OA) undergoing a three-shot dextrose prolotherapy (DPT) injection series did not negate the efficacy of DPT. Additionally, it showed that giving both treatments simultaneously is safe and efficacious. The small sample size and design of the pilot study limited the conclusions that can be drawn on the concomitant use of non-steroidal anti-inflammatory drugs (NSAIDs) during DPT treatment. This is a double-blinded, randomized, controlled trial that includes a subject population of males and females between the ages of 45-75 years who are DoD beneficiaries empaneled at DGMC with a history of chronic, symptomatic knee osteoarthritis in one or both knees, that meet study criteria. Participants will have study inclusion/exclusion and knee films (within the past 2 years) reviewed by a study investigator to confirm eligibility to participate in the study. Eligible participants will be consented then randomized into treatment groups (ibuprofen, placebo) by the pharmacy. Participants will provide a baseline assessment of pain and dysfunction using the Numeric Pain Rating Scale (NPRS) and Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaires. Participants will then have a series of three injections of 4mL of 25% dextrose mixed with 1% lidocaine into the knee under ultrasound guidance, performed at 0, 4 and 8 weeks (+/- 1 week) in addition to a 7-day supply of the study drug (ibuprofen, placebo) at these time points. NPRS and KOOS scores will be collected at 0, 4, 8 and 12 weeks. During the study period, participants will be counseled to avoid oral analgesics (other than what has been prescribed for them as part of the study) including NSAIDs, acetaminophen, or opioids, in addition to other procedures to treat their knee pain to include other injections, acupuncture, physical therapy, and surgery. The primary outcome is to determine the effect of concomitant oral ibuprofen vs. placebo use on intra-articular knee injections using hypertonic dextrose and the determine the short and long-term outcomes in each treatment group (ibuprofen, placebo) using the NPRS and KOOS questionnaires to assess pain and function.

Knee Osteoarthritis and Spa Therapy

The aim of this clinical trial is to assess the efficacy of the 18-day balneotherapy program (therapeutic indication: Rheumatology) in terms of functional incapacity and the disorders (pain, joint stiffness) induced by osteoarthritis of the knee, and thus improves patients\' quality of life, in patients presented with knee osteoarthritis. The French National Academy of Medicine encourages the re-use of RCT data when available. In this context, the current study is designed as a single-arm prospective study with external comparison using the propensity score. The Control group consists of the patients which were allocated to the Control group of reference randomized clinical trial (RCT) "ANGELLO Study" (NCT05819437). These patients received standard care for knee osteoarthritis, i.e., pain management and exercise recommendations. All patients enrolled in the current study benefit of 18-day balneotherapy program (therapeutic indication: Rheumatology) with Mineral Water of Santenay (Burgundy, France), and examination with a practitioner at enrollment and 6 months after the beginning of spa treatment.

Genicular Artery Embolization for Reducing Pain in Medically Refractory Symptomatic Knee Osteoarthritis

Genicular Artery Embolization for Reducing Pain in Symptomatic Knee Osteoarthritis: A Pilot Randomized Sham-Controlled Study (SHAM-PAIN) is a NIH-NIAMS funded project designed to assess enrollment feasibility and detect any differences between GAE and a similar sham intervention in reducing KOA-related pain at 3 months as measured by the Knee injury and Osteoarthritis Outcome Score (KOOS) pain subscore. Additionally, this study aims to determine the magnitude of difference in pain response between GAE and sham to adequately power a larger, more definitive randomized sham-controlled trial (RCT). The influence of psychosocial and psychocognitive factors, changes in analgesic use, and conditions of knee joint cartilage and effusion will similarly be explored to determine their impacts on perceived pain response to GAE.

Clinical Study on the Combination of Xiaoyu Zhitong Formula and Lymphatic Drainage Technique to Improve the Symptoms of Knee Pain and Swelling in Cold Dampness Obstruction Type

This research project applies a combination of blood stasis relieving and pain relieving formula and lymphatic drainage technique to treat patients with cold dampness obstruction type knee joint pain. The improvement of knee joint pain scores and activity function as well as the degree of soft tissue swelling changes are observed before and after receiving this therapy providing certain ideas for the comprehensive treatment optimization and prognosis judgment of cold dampness obstruction type knee joint pain.

Creation of a Prospective Data Collecting Registry for Genicular Artery Embolization for Arthritis

The goal of this study is to create a prospective registry (\<100 patients) to show the effectiveness of the genicular artery embolization procedure overtime in reducing bilateral or unilateral osteoarthritic knee pain as measured by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score.

Effects of Core Stabilization Exercises Versus Foot-Ankle Strengthening Program in Patients With Knee Osteoarthritis.

Knee osteoarthritis (OA) is also known as degenerative joint disease, is typically the result of wear and tear and progressive loss of articular cartilage. It is most common in the elder population. It results from functional disability and altered knee biomechanics. Risk factors of Knee OA include; older age, genetics and obesity, female gender. The aim of this study is to compare the effects of core stabilization exercises versus foot-ankle strengthening program on pain, physical function and quality of life in patients with knee osteoarthritis.