Clinical Research Directory

Impact of Blood-Flow-Restriction Prehabilitation on Pre- and Postoperative Rehabilitation After Total Knee Arthroplasty

Degenerative and traumatic diseases of the musculoskeletal system lead to increased immobility of a patient, which in turn results in muscle atrophy. BFR training is a training method in which a blood pressure cuff partially blocks the arterial blood flow to the exercising limb and completely blocks the venous blood flow. During exercise, an externally induced venous occlusion occurs. This stimulus increases the metabolic stimulus in the occluded extremity - this means that strength can be increased even with low weights, which is why this training is also suitable for people who should not use high training loads due to injuries or operations.

Patient Pain and Function in Medial Knee Osteoarthritis After Anteromedial vs Anterolateral Intra-Articular Corticosteroid Injection

The primary purpose of this study is to find out if there is a difference in pain experienced in patients with knee arthritis of the inside of their knee if they get a steroid injection on the inside or outside of their knee. Participants will: 1. Be randomly divided into getting their steroid injection on the inside or outside of their knee. 2. Answer a pain survey before their injection as well as over the phone 2 weeks, 6 weeks, and 12 weeks after their injection.

LinkSymphoKnee (LSK) Total Knee Replacement System Study - Ultra-congruent (UC)

To collect information about implant performance and patient clinical outcomes in patients undergoing primary total knee arthroplasty with the LinkSymphoKnee total knee replacement system with ultra-congruent tibial bearing surface.

Impact of Bone-Marrow Aspirate Injections in Knee Arthroscopy

This study will examine whether using bone marrow aspirate (BMA) during knee arthroscopy surgery can improve patient outcomes. The investigators will enroll 50 patients who need knee arthroscopy surgery for meniscus injuries or cartilage damage. Like flipping a coin, patients will be randomly assigned to one of two groups of 25 patients each. One group will receive standard arthroscopic surgery plus an injection of bone marrow aspirate, while the other group will receive standard surgery plus a saline (salt water) injection. During surgery, for patients in the treatment group, approximately 4mL (less than one teaspoon) of bone marrow will be taken from their hip bone using a special needle system. A small amount (1mL) will be sent to the laboratory for testing. Patients will be followed for 12 months after surgery and will complete questionnaires about their pain levels and knee function at several time points: before surgery, 2 weeks, 6 weeks, 3 months, 6 months, and 12 months after surgery. These questionnaires will ask about pain, daily activities, and overall improvement.

Efficacy of Platelet-Rich Plasma Added to Hyaluronic Acid in Knee Osteoarthritis

This prospective, randomized, open-label, single-centre post-market clinical follow-up (PMCF) study evaluates the clinical performance and safety of a single intra-articular injection of hyaluronic acid (HA) combined with autologous platelet-rich plasma (PRP) compared with a single intra-articular injection of HA alone in adults with symptomatic knee osteoarthritis (Kellgren-Lawrence grade II or III). Knee osteoarthritis is a chronic degenerative joint disease associated with pain, functional limitations, and reduced quality of life. Hyaluronic acid is widely used as viscosupplementation therapy, while platelet-rich plasma provides autologous growth factors that may contribute to the modulation of inflammatory processes and tissue healing. The combination of HA and PRP may provide complementary effects and may offer additional clinical benefit compared with HA alone. A total of 50 participants will be randomized in a 1:1 ratio to receive either a single intra-articular injection of 3.8 mL HA combined with 1 mL autologous PRP or a single intra-articular injection of 4.8 mL HA. Participants will be followed for 18 months. The primary endpoint is the between-group difference in change in knee pain measured using the Numeric Rating Scale (NRS) from baseline to Month 6. Secondary outcomes include changes in pain intensity, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Knee injury and Osteoarthritis Outcome Score (KOOS), quality of life measures, and safety assessments throughout the follow-up period. Both medical devices are CE-marked and are used for their intended purpose. The study is conducted as a PMCF investigation in accordance with Regulation (EU) 2017/745 (MDR).

Efficacy of Platelet-Rich Plasma Combined With Hyaluronic Acid in Knee Osteoarthritis

This prospective, randomized, open-label, single-centre post-market clinical follow-up (PMCF) study evaluates the clinical performance and safety of a single intra-articular injection of hyaluronic acid (HA) combined with autologous platelet-rich plasma (PRP) compared with a single intra-articular injection of HA alone in adults with symptomatic knee osteoarthritis (Kellgren-Lawrence grade II or III). Knee osteoarthritis is a chronic degenerative joint disease associated with pain, functional limitations, and reduced quality of life. Hyaluronic acid is widely used as viscosupplementation therapy, while platelet-rich plasma provides autologous growth factors that may contribute to the modulation of inflammatory processes and tissue healing. The combination of HA and PRP may provide complementary effects and may offer additional clinical benefit compared with HA alone. A total of 50 participants will be randomized in a 1:1 ratio to receive either a single intra-articular injection of 3.8 mL HA combined with 1 mL autologous PRP or a single intra-articular injection of 4.8 mL HA. Participants will be followed for 18 months. The primary endpoint is the between-group difference in the change in knee pain, measured using the Numeric Rating Scale (NRS), from baseline to Month 6. Secondary outcomes include changes in pain intensity, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), the Knee Injury and Osteoarthritis Outcome Score (KOOS), quality-of-life measures, and safety assessments throughout the follow-up period. Both medical devices are CE-marked and are used for their intended purpose. The study is conducted as a PMCF investigation in accordance with Regulation (EU) 2017/745 (MDR).

A Study to Assess Safety and Tolerability of PCRX-201 in Subjects With Painful Osteoarthritis of the Knee

The goal of this clinical trial is to learn if a single knee injection of different doses (Dose A and Dose B) of an investigation product PCRX-201, following steroid pretreatment, is safe and tolerable in male of female patients 45 to 80 years old with osteoarthritis of the knee. It will also learn how the body reacts to the PCRX-201 injection and how effective the treatment is. Researchers will compare Dose A and Dose B of PCRX-201 versus placebo from Week 1 through Week 52 to assess adverse events. Researchers will also explore how PCRX-201 may impact knee pain and joint function over time. Participants will be asked to * Visit the clinic for pretreatment and drug administration * Visit the clinic for checkups and tests: 1. Screening through Week 52: intially weekly, bi-weekly, later monthly 2. Week 53 through Week 260 (Year 5): 8 visits throughout the period

Evaluation of Choose to Move Replacement Ready (CTM-RR)

Choose to Move (CTM) is a 3-month, choice-based health-promoting program for low active older adults being scaled-up across British Columbia (BC), Canada. Recently, the investigators adapted CTM for the \>14000 people in BC who are on surgical waitlists for total knee replacement or total hip replacement (TKR/THR) for osteoarthritis (OA). The primary goals of this observational study are to describe how the adapted program, Choose to Move Replacement Ready (CTM-RR), is implemented in BC and determine if the adapted program improves health outcomes in people with hip and/or knee osteoarthritis who are on surgical waitlists for TKR/THR. The investigators will also evaluate whether any health benefits achieved by CTM-RR participants are maintained three months after they finish the program and also during the remaining time that they wait for their TKR/THR surgery. The investigators will work with referral partners from hospitals and orthopaedic clinics in BC to recruit participants into CTM-RR. Participants who enrol in CTM-RR will answer online survey questions about the program and about their physical activity, mobility, pain, function, quality of life, willingness to undergo surgery, overall perception of their joint condition, psychosocial health, self-efficacy, social isolation, loneliness, and sedentary time. CTM-RR activity coaches will also answer online survey questions about the program. CTM-RR participants, activity coaches, and referral partners will also participate in interviews about the program.

GENicular Nerve Block in KNEE Arthroplasty

The goal of this clinical trial is to learn whether a preoperative genicular nerve block (GNB) can reduce pain after knee replacement surgery in adults with knee osteoarthritis (OA) undergoing total knee arthroplasty (TKA). It will also assess whether this treatment can reduce opioid use and improve recovery. The main questions it aims to answer are: * Does a preoperative GNB reduce pain during movement 24 hours after surgery compared with placebo? * Does it reduce opioid consumption and improve physical activity and functional outcomes after surgery? Researchers will compare patients receiving a GNB to patients receiving a placebo injection to see if the nerve block improves postoperative pain and recovery. Participants will: * Be randomly assigned to receive either a GNB or a placebo injection before surgery * Undergo standard knee replacement surgery and postoperative care * Report pain levels at regular intervals after surgery * Complete questionnaires on function, quality of life, and recovery * Wear an activity monitor to measure physical activity after surgery * Attend follow-up assessments at 1 week, 1 month, and 3 months

Novel Extended-Release Bupivacaine Polymer for Sustained Pain Relief Following Total Knee Arthroplasty

Participants are being invited to take part in a research study about pain control after total knee replacement surgery (also called total knee arthroplasty or TKA). The goal of this study is to see if a new long-acting medication, called Zynrelef, can control pain after surgery as well as or better than two other common pain treatments - a nerve block or a standard injection into the knee during surgery. Knee replacement is done to reduce pain and improve movement in people with severe knee arthritis. While the surgery can be very successful, pain during the first few days after surgery can make recovery harder. Many patients need strong opioid pain medicines, but these medicines can have side effects and may lead to dependence. The investigators want to find ways to control pain that reduce or even remove the need for opioids. If participants join this study, they will be randomly placed (like flipping a coin) into one of three groups: Standard injection (PAI) - a mix of medicines injected into the knee during surgery. Zynrelef - a new long-acting medicine put directly into the knee during surgery, along with a smaller dose of the standard injection. Nerve block (ACB) - medicine given near a nerve in the leg before surgery to block pain. All participants will get the same medicines before and after surgery, follow the same physical therapy program, and have the same follow-up visits. Participants will be asked to record their pain scores and the pain medicines they take for several weeks after surgery. The risks of joining are small and similar to those of routine care. All three pain control methods are already used in regular knee replacement surgery. Possible side effects may include temporary numbness, weakness, or soreness from the injections, and the usual surgical risks such as infection. Participants may benefit from better pain control, less need for opioids, and a smoother recovery. The results from this study may also help future patients have safer and more comfortable knee replacements. Taking part is voluntary. Participants can leave the study at any time without affecting their medical care.

Total Osteo-Cartilage Replacement for the Treatment of Osteoarthritis of Knee

Young patients who require total knee arthroplasty with metallic and plastic implants will undergo femoral condyle cartilage and top of the tibia with meniscus replacement. With the proposed surgery patients will have increased range of movements so that they can sit on the ground to fulfill their social was of life, which is not possible with the standard of care total knee replacement.

Optimization of Obesity for Total Knee Replacement With Glucagon-like Peptide-1 Receptor Agonist

Studies have shown that obese patients undergoing total knee replacement (TKR) surgery face a higher risk of perioperative issues such as increased use of pain medication, surgical site infections, and the need for revision surgeries compared to non-obese patients. Obesity is also linked to more significant preoperative pain and lingering symptoms post-surgery. Consequently, there's a growing interest in weight loss interventions prior to TKR to enhance perioperative care and outcomes. Recent retrospective studies have indicated that such interventions can improve physical function post-TKR. Research focusing on weight loss interventions before joint replacement surgery is limited. There is currently a gap in research regarding RCTs on weight loss interventions using anti-obesity drugs before TKR, particularly in Asian populations. One promising avenue under exploration involves the use of glucagon-like peptide 1 receptor agonists (GLP-1RAs) as anti-obesity medication before total knee replacement (TKR) surgery. However, there are currently no randomized controlled trials (RCTs) examining the effects of GLP-1RAs on knee arthroplasty outcomes. Large database studies have indicated that GLP-1RAs may decrease the likelihood of certain post-surgery complications but increase the risk of others. In summary, addressing obesity through weight loss interventions, particularly with GLP-1RAs, holds promise for improving outcomes in TKR patients. However, further research, including randomized controlled trials, is necessary to fully understand the effects of GLP-1RAs on perioperative outcomes and patient health.

Systemic Oral Glucocorticoids for the Treatment of Acute Osteoarthritis Pain in the Emergency Department

The purpose of this clinical trial is to compare the analgesic effects (relief of pain) of glucocorticoids (steroids) and pain medication versus pain medication alone in adult patients presenting to the emergency department with joint pain due to osteoarthritis. Steroids are drugs that can reduce inflammation and are used commonly for many different medical conditions. In brief, the central aims of the study are to: 1. Assess the efficacy of adding oral glucocorticoid medications to the standard pain medications used to treat the pain of osteoarthritis. 2. Assess the safety and tolerability of oral glucocorticoid medication for the short-term treatment of osteoarthritis pain. We hypothesize that: 1) The addition of glucocorticoids to standard pain medications will improve reported pain scores at 3 days following the initiation of treatment compared to standard pain medications alone and 2) The use of glucocorticoids will be well tolerated. Participants in the study will be randomized (like flipping a coin) into one of three groups: 1. Study Group 1 (Control) receiving placebo pills (no active ingredient) once a day for 5 days, plus ibuprofen (pain medication) for 5 days. 2. Study Group 2 (Intervention A) who will receive prednisone (steroid) once a day for 5 days, plus ibuprofen (pain medication) for 5 days. 3. Study Group 3 (Intervention B) who will receive one dose of dexamethasone (steroid) followed by placebo pills (no active ingredient) once a day for 4 days, plus ibuprofen (pain medication) for 5 days. In all groups, acetaminophen (a different pain medication) can be taken as needed for pain that is not controlled with ibuprofen. Participants will: * Receive follow up phone calls at 1, 3, 7 and 14 days. * Report pain scores related to joint pain. * Report the number of pills taken of the various medications used in the study. * Report any adverse events incurred during the follow up period.

Anti-Diabetic Drug, Exercise and Healthy Diet for Knee Osteoarthritis With Overweight/Obesity

Obesity is associated with increased pain with knee osteoarthritis and increase progression of knee osteoarthritis while weight loss intervention has been shown to reduce pain and requirement of total knee replacement. In this study, the investigators will assess using diet modification with exercise, and metformin, a common, safe, diabetes mellitus medication that has been in use for 70 years to achieve better weight control to reduce knee pain. This helps the investigators to understand whether the combined treatment can reduce joint pain, reduce body weight and improve symptoms and requirement of total knee replacement.

Cohort of Lower-Extremity Sports Injuries and Degeneration(Yongjiang Cohort)

This is an observational cohort study conducted at Ningbo No. 2 Hospital. The study will include patients with knee-related sports injuries or degenerative knee conditions who receive routine clinical care. The purpose is to build a standardized real-world clinical cohort and evaluate knee injury, degeneration, recovery, and long-term outcomes. After informed consent, participants will undergo baseline data collection, including medical history, laboratory tests, questionnaires, X-ray and MRI imaging, and functional assessments. Patients younger than 50 years will mainly be assessed for sports injury and functional recovery, while patients aged 50 years or older will receive additional sarcopenia-related assessments such as grip strength, DXA testing, and gait evaluation. No experimental treatment, randomization, or intervention will be assigned. Participants will be followed at about 6, 12, and 24 months after treatment or surgery to assess knee function, imaging changes, reinjury, reoperation, pain, quality of life, falls, and functional decline. The study plans to enroll about 500 participants.

Imageless Navigation Versus Image-Based Navigation in Robotic-Assisted Total Knee Arthroplasty for Knee Osteoarthritis

The goal of this clinical trial is to learn if imageless navigation is not inferior to image-based navigation in robotic-assisted total knee arthroplasty (RA-TKA) for treating patients with knee osteoarthritis. The main questions the study aims to answer are: 1. Does imageless procedure provide functional results comparable to those of image-based navigation? 2. Are there differences in postoperative complications patients may experience after RA-TKA with imageless and image-based navigation? Researchers will compare imageless navigation with image-based navigation used in total knee arthroplasty to assess whether imageless navigation is comparable for the treatment of knee osteoarthritis. Participants will: 1. Answer survey questions about knee pain and function before RA-TKA. 2. Undergo RA-TKA with imageless navigation or image-based navigation. 3. Visit the Clinic after 6 months and 12 months after surgery for checkups and to answer the same survey questions about postoperative knee pain and function.

Comparison of Postoperative Functional Outcomes Between Subvastus and Medial Parapatellar Approach in Total Knee Arthroplasty

This study aims to compare the effects of the medial parapatellar approach (MP) and the subvastus approach (SV) on postoperative clinical function in total knee arthroplasty (TKA). A total of 84 patients, who visit the Joint Surgery Department of Peking University Third Hospital and are diagnosed with end-stage knee osteoarthritis and require unilateral, primary total knee arthroplasty, will be recruited. The patients will be randomly assigned to two groups, with 42 patients in each group. TKA will be performed using the MP and SV approaches respectively. Postoperative data such as quadriceps muscle strength, the time of first unassisted straight leg raise (SLR), joint range of motion (ROM), KSS score, WOMAC score, SF-12 score, VAS score, and shear wave elastography (SWE) of the medial thigh muscle will be collected. The patients will be followed up for 2 years postoperatively to compare the short-term and long-term clinical functional outcomes of the two surgical approaches.

ASKC200 for Knee Osteoarthritis Pain

This is a Phase II clinical trial designed to evaluate the efficacy and safety of ASKC200 Lotion in patients with knee osteoarthritis (KOA) pain. A total of 175 eligible patients will be randomly assigned to three groups at a 1:2:2:2 ratio: the experimental group1 (treated with 1% ASKC200 Lotion), the experimental group 2(treated with 5% ASKC200 Lotion), the active control group (treated with Diclofenac Diethylamine Emulgel), and the placebo group (treated with matching placebos).

COntralateral CorticoSTeroid Injection in Total Knee Arthroplasty

Through a triple-blinded randomized control trial, the primary purpose of this pilot study is to assess the efficacy of administering peri-operative contralateral corticosteroid injection in patients undergoing TKA. The secondary outcome was to assess the effect of contralateral corticosteroid injection on pain and functional outcomes of patients undergoing TKA.

Extended Post-operative Oral TXA in Primary THA

The goal of this clinical trial is to learn if extended post-operative oral tranexamic acid (TXA) - a medication that reduces bleeding by slowing the breakdown of blood clots - can improve functional recovery following surgery in adults undergoing primary total knee or hip arthroplasty for osteoarthritis. The main question it aims to answer is: Does extended post-operative oral TXA improve functional outcomes at 6 weeks post-operatively compared to standard perioperative TXA alone? Researchers will compare patients receiving extended oral TXA to patients receiving matching placebo capsules on the same schedule to see if the extended TXA regimen reduces blood loss, improves early functional outcomes, and reduces pain without increasing complication rates. Participants will receive standard perioperative oral TXA (1.95 g) prior to surgical incision, along with standard VTE prophylaxis. They will be randomly assigned to receive either oral TXA or matching placebo capsules once daily on post-operative days 1, 2, and 3. Participants will attend follow-up visits at 2, 6, and 12 weeks post-operatively to complete functional outcome questionnaires, pain assessments, and - for knee replacement patients - range of motion measurements.

Post-Operative Pain Relief: Zynrelef or Periarticular Injections in RATKA

Prospective Cohort of patients who are scheduled for a Robot Assisted Total Knee Arthroplasty (RATKA). A prospective survey of patient reported outcome measures (Numeric Rating Scale) will be obtained postoperatively of 72 hours, as well as at the postoperative opioid consumption after 72 hours.

Pain Perception During Intra-Articular Knee Joint Injection: What is the Effect of Needle Gauge and the Use of Ethyl Chloride?

This study aims to investigate factors that affect the subjective experience of pain during and after intra-articular knee joint injection of steroids by comparing needle gauge size (22 G vs 25 G needles), as well as the presence or absence of topical ethyl chloride spray. Additionally, this study will investigate the effects of other various factors on patients' pain associated with the injection. Lastly, this study aims to determine the effect of patients' subjective pain from the injection on long-term clinical outcomes. Specific aims are as follows: Aim 1): Determine the effect of needle gauge size on patient reported pain associated with an ultrasound-guided intra-articular knee injection. Aim 2): Determine the effect of ethyl chloride spray on patient reported pain associated with an ultrasound-guided intra-articular knee injection. Aim 3): Determine the effect of sex, age, BMI, thigh size, severity of OA, and fear of needles on patient pain associated with an ultrasound-guided intra-articular knee injection. Aim 4) Determine the effect of patient pain from the procedure on longer term clinical outcomes after an ultrasound-guided intra-articular knee steroid injection. Researchers will obtain data at various time points, including pre-procedural data, immediately after the procedure, 24-48 hours after, and 6 weeks post-procedure. Participants will: Consent to receiving an intra-articular knee joint injection with steroids if indicated. Score their "procedural" pain immediately following the procedure, score their post-procedural "soreness" 24-48 hours after via telephone call, and score their overall knee pain about 6 weeks after the procedure via telephone call.

Pharmacist-physiotherapist Collaborative Management for Early Knee Osteoarthritis

Osteoarthritis (OA) is a slowly progressive chronic condition that is associated with aging and is characterized as joint pain. Individuals with early-stage OA usually do not seek medical attention. If and when they do, patients more often present to a pharmacy for over-the-counter medications. The investigators want to leverage community pharmacists' accessibility and scope of practice to best support patients with early knee OA. Given there are no disease-modifying treatments for OA, treatment guidelines center on patient education, self-management, and exercise, with medications playing a supporting role. Self-management is an effective strategy that provides a solid foundation for managing this progressive chronic condition and health care professionals like physiotherapists and pharmacists can help with the development and application of these skills.

Percutaneous Neurostimulation in Knee Osteoarthritis

Peripheral nerve stimulation (PNS) is a drug-free pain management procedure that uses electrical impulses to target specific nerves and block pain signals. PNS helps decrease perception of pain, providing real answers to patients dealing with chronic knee pain. The case study discussed in this presentation is of the use of PNS targeting the superior lateral genicular nerve and the saphenous nerve for a patient with moderate to severe knee pain from osteoarthritis