Clinical Research Directory

Programmed Intermittent Epidural Bolus Versus Continuous Epidural Infusion for Postoperative Analgesia After Total Knee Arthroplasty

The goal of this clinical trial is to compare two different epidural analgesia delivery methods for pain control after total knee arthroplasty in adults undergoing elective surgery. The study will evaluate whether programmed intermittent epidural bolus (PIEB) provides better postoperative analgesia and recovery outcomes than continuous epidural infusion (CEI). The main questions it aims to answer are: Does PIEB reduce total epidural local anesthetic consumption during the first 24 postoperative hours compared with CEI? Does PIEB improve postoperative pain control and quality of recovery? Are there differences between the two methods regarding motor block, rescue analgesic requirement, patient-controlled epidural analgesia use, and adverse effects? Researchers will compare PIEB plus patient-controlled epidural analgesia (PCEA) with CEI plus PCEA in patients undergoing total knee arthroplasty. Participants will: Receive combined spinal-epidural anesthesia during surgery Receive postoperative epidural analgesia using either PIEB or CEI Be evaluated for pain scores, motor block, recovery quality, epidural local anesthetic consumption, rescue analgesic requirement, and adverse events during the first 24 postoperative hours

Investigation of the Individual Fatigue Response During Blood Flow Restriction Training

The aim of the present pilot study is to investigate the feasibility of an exercise pressure response approach for assessing physiological strain during BFR training in a clinically supervised setting. Patients undergoing rehabilitation following total knee arthroplasty (TKA) will be included. The results are intended to contribute to an improved evaluation of load management during BFR training.

Proximal Spread in Adductor Canal Block(ACB)

This prospective, randomized clinical study is designed to evaluate the effects of two different injection levels of adductor canal block (ACB) on the proximal spread of local anesthetic and clinical outcomes in patients undergoing total knee arthroplasty. The study will be conducted at Ankara Etlik City Hospital and will include a total of 68 patients. All cases are limited to unilateral elective knee replacement surgeries performed under spinal anesthesia. In this study, the comparison will be based on the application of adductor canal block at two distinct injection levels. In both groups, blocks will be performed under ultrasound (USG) guidance using the same technical principles and standardized conditions; in the first group, the block will be administered at the level where the vasto-adductor membrane is first visualized, while in the second group, it will be performed at the level where the adductor longus ends. The type, concentration, and volume of local anesthetic used in both groups will be standardized as 20 mL of 0.25% bupivacaine. The groups will be compared in terms of the proximal spread of the local anesthetic based on the injection level, the area of spread at the apex of the iliopectineal fossa, the involvement of the femoral nerve, the incidence of postoperative falls, and analgesic consumption.

Efficacy of Genicular Block on Total Knee Arthroplasty Surgery

The aim of this study is to investigate the postoperative pain relieving effect of preoperative genicular block in total knee arthroplasty surgery. The main questions it aims to answer are: 1. Do visual analog scale (VAS) scores decrease in patients who underwent geniculate block? 2. Does opioid consumption decrease in patients who underwent geniculate block? Researchers will compare postoperative pain in patients who received genicular block with those who did not.One group of patients will be administered 0.25% bupivacaine with the geniculate block method. The other group will not undergo any intervention. Both groups will be administered intravenous morphine for postoperative analgesia.

Impact of Chronic Venous Insufficiency on Outcomes After Total Knee Arthroplasty

Total knee arthroplasty (TKA) is an effective treatment for end-stage knee osteoarthritis; however, postoperative complications-particularly wound healing problems-remain a significant concern. Chronic venous insufficiency (CVI) is associated with venous hypertension, impaired microcirculation, and tissue hypoxia, which may negatively affect wound healing and increase complication rates. This prospective observational cohort study aims to evaluate the impact of preoperative CVI on postoperative outcomes following TKA. Patients will be assessed preoperatively using the CEAP classification and Doppler ultrasonography to identify and stratify venous insufficiency. Participants will be followed for 12 months postoperatively. The primary outcome will be wound healing complications in the early postoperative period. Secondary outcomes will include functional outcomes assessed by the Knee Society Score (KSS), patient-reported outcomes using the WOMAC score, and overall complication rates. The findings of this study are expected to clarify the role of venous insufficiency as a potential risk factor in TKA and may contribute to improved preoperative risk stratification and postoperative management strategies.

The Effects of Mir Shakeel Teleintegrated Therapy Plan in Patients Undergoing Total Knee Arthroplasty

This randomized controlled trial aims to evaluate the effectiveness of a newly developed Modified Structured Telerehabilitation Intervention Protocol (MSTITP) compared with conventional in-person physical therapy in patients recovering from Total Knee Arthroplasty (TKA). The study also explores whether a hybrid rehabilitation approach may further optimize patient outcomes. A total of eligible participants aged 50-65 years who have undergone primary TKA will be randomly assigned to one of two groups: Group A (Intervention): Telerehabilitation-based structured exercise program (MSTITP) delivered through digital platforms with remote supervision. Group B (Control): Standard conventional face-to-face physiotherapy in a clinical setting. Both groups will receive rehabilitation programs of equal duration focusing on pain management, range of motion (ROM), muscle strengthening, gait training, and functional mobility. The primary objective is to compare the effectiveness of telerehabilitation and conventional therapy in improving pain, ROM, and gait performance. Secondary objectives include evaluation of exercise adherence, kinesiophobia, functional outcomes, quality of life, and patient satisfaction. Additionally, the study will explore whether integrating telerehabilitation with conventional rehabilitation could provide superior outcomes. Outcome assessments will be conducted using validated tools including pain scales (VAS), goniometric ROM measurements, gait analysis, functional performance tests, and standardized questionnaires for quality of life, exercise adherence, and fear of movement. This study addresses the increasing burden of osteoarthritis and the growing number of TKA procedures in Pakistan. Telerehabilitation may offer a cost-effective, accessible, and scalable rehabilitation model that ensures continuity of care and improved access to physiotherapy services, particularly in resource-limited settings. The findings of this trial are expected to provide evidence for developing standardized, technology-assisted rehabilitation protocols to improve post-TKA recovery outcomes and reduce healthcare burden.

Comparison of Ultrasound-Guided Lumbar ESPB and ACB for Knee Arthroplasty

Total knee arthroplasty (TKA) is a surgical procedure frequently associated with moderate-to-severe postoperative pain. While Adductor Canal Block (ACB) has demonstrated analgesic efficacy in TKA, the Erector Spinae Plane Block (ESPB) is also being utilized as part of multimodal analgesia for postoperative pain management in lower extremity surgeries. Currently, there is a gap in the literature as no studies have directly compared the efficacy of ACB and ESPB for pain management following TKA. The primary objective of this study is to compare the efficacy of these two analgesic methods in the context of postoperative analgesia management after total knee arthroplasty.

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.

Liposomal Bupivacaine Versus Ropivacaine With Perineural Dexamethasone or Dexmedetomidine as Adjuncts for Adductor Canal Block Combined With IPACK Block in Total Knee Arthroplasty

Effective postoperative pain management remains a cornerstone of enhanced recovery protocols following total knee arthroplasty (TKA). Inadequate analgesia not only compromises patient satisfaction but also impedes early mobilization and rehabilitation, thereby increasing the risk of perioperative complications. Current multimodal analgesic strategies frequently incorporate regional techniques, with the adductor canal block (ACB) and infiltration between the popliteal artery and capsule of the knee (IPACK) block emerging as established modalities that provide motor-sparing analgesia. Despite their widespread adoption, the optimal local anesthetic regimen for these blocks remains undefined. While liposomal bupivacaine has garnered interest for its extended duration of action, its clinical efficacy relative to conventional local anesthetics combined with perineural adjuncts remains a subject of ongoing debate. Specifically, perineural dexamethasone and dexmedetomidine have each demonstrated the capacity to prolong the analgesic duration of ropivacaine; however, direct comparative data among these three distinct strategies-liposomal bupivacaine alone versus ropivacaine supplemented with either adjunct-are notably limited. Given the absence of head-to-head randomized trials evaluating these three clinically viable techniques, the optimal approach to maximize analgesic duration while minimizing opioid-related adverse effects remains unclear. This study therefore aims to compare the analgesic efficacy and safety profiles of liposomal bupivacaine, ropivacaine with perineural dexamethasone, and ropivacaine with perineural dexmedetomidine when administered via ACB and IPACK blocks in patients undergoing TKA.

Effect of Combined Adductor Canal and AFCN Block on Postoperative Inflammation

The aim of this thesis is to evaluate the effects of adding an anterior femoral cutaneous nerve (AFCN) block to the adductor canal block used for postoperative analgesia after total knee arthroplasty on the postoperative inflammatory response, as assessed by inflammatory biomarkers including NLR, PLR, AISI, and CAR.

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.

Knee Flexionater to Avoid Motion Restoring Surgery

The goal of this clinical trial is to learn whether adding a stretching device to standard physical therapy can help people regain knee bending after total knee replacement surgery. Some people have difficulty bending their knee during recovery. When this happens, doctors may recommend another procedure called motion-restoring surgery to improve knee movement. This study aims to answer two main questions. First, does adding a hydraulic high-intensity stretching device to physical therapy help people regain knee bending after surgery? Second, does using the device affect recovery, daily activities, or the chance of needing another procedure? Researchers will compare two treatment approaches. One group will receive standard physical therapy alone. The other group will receive standard physical therapy and will also use a hydraulic high-intensity stretching device called the Ermi Knee Flexionater at home. Participants who receive the device will use it at home each day in addition to attending their physical therapy sessions. Researchers will measure how well participants can bend their knee and will ask questions about pain, daily function, and activity level. Participants will also complete simple walking and mobility tests. Study visits will occur about four weeks after surgery when participants enroll, and again at about eight weeks, twelve weeks, six months, one year, and two years after surgery. Researchers will compare results between the two groups to see whether the stretching device improves recovery after knee replacement.

Monocentric Randomised Controlled Trial Assessing Cryocompression Following Total Knee Replacement

Immediately following surgery, icepacks are commonly used to decrease inflammation and reduce pain and have demonstrated to decrease post-operative opioid consumption. New cryocompression devices have been introduced as a non-invasive and non-pharmacological modality used to manage acute inflammation and pain, demonstrating benefits in the post- operative setting promoting vasoconstriction, reducing blood flow and inflammation. The addition of compression may further decrease inflammation and pain, revealed in studies on anterior cruciate ligament reconstruction, total hip replacement, and lumbar fusion. Recently, an RCT was published by Marinova et al. that compared cryocompression to icepacks following TKR in terms of pain on VAS, range of motion (ROM), knee circumference, and opioid consumption, but only found significant differences in extension ROM at day 1 and at 2 weeks. Due to the small sample size of Marinova et al. and high rates of losses to follow-up due to COVID-19, there remains doubt on the efficacy of cryocompression for TKR. Furthermore, cryocompression require additional investment in terms of cost to acquire the devices, and in time to train the hospital staff, and the devices may not be available for every patient. Finally, the authors are unsure how cryocompression affects wound healing in the short- and long-term. The hypothesis was that both cryocompression and regular icepacks would grant equivalent pain on numeric rating scale at 48 hours postoperatively.

Using a Smart Implantable Device to Compare Early Recovery in Two Different Knee Arthroplasty Approaches

This is a single-institution, prospective, randomized study comparing the medial parapatellar and subvastus approaches in primary total knee arthroplasty using continuous, implant-based gait monitoring. Patients receiving a Zimmer Persona IQ smart implant will be followed preoperatively and through the first 30 days post-operatively, with extended follow-up to 6 months. Preoperative activity is captured using iPhone Health step-count data, while post-operative recovery is assessed using continuous tibial implant data, including step count, range of motion, cadence, walking speed, stride length, and distance. These objective metrics are correlated with PROMs. The primary outcome is daily step count. Secondary outcomes include early functional milestones, pain, and patient-reported functional scores. This study is designed to characterize early recovery trajectories and determine whether meaningful differences exist between surgical approaches.

Drain Removal Before Versus After CPM in Primary Total Knee Arthroplasty

The aim of this prospective randomized controlled study was to determine whether the timing of drain removal in relation to continuous passive motion (CPM) application influences postoperative residual hematoma formation following primary total knee arthroplasty (TKA). Our primary hypothesis was that removing the drain after initiating CPM would result in less residual hematoma, as CPM-induced intra-articular fluid and blood mobilization would be evacuated through the drain before its removal, thereby reducing postoperative fluid accumulation.

The Sacral Erector Spinae Plane Block in Total Knee Arthroplasty

The goal of this observational study is to learn about the analgesic efficacy and postoperative recovery of two locoregional anesthesia combinations in patients \> 18 years (ASA I-III), scheduled for unilateral TKA under spinal anesthesia with expected hospitalization \> 24 hours: * ACB + sacral ESP block * ACB + iPACK block The main question it aims to answer is: Does the ACB + sacral ESP block combination produce effective postoperative recovery and analgesic effect? Participants already taking ACB + sacral ESP block as part of their regular peri-operative care for TKA will be followed in the postoperative period for 48 hours.

Dinalbuphine Sebacate in Postoperative Pain Control After TKA

To evaluate the effectiveness of Dinalbuphine Sebacate for controlling subacute pain after total knee arthroplasty

ACU_Knee: Role of Acupuncture in Knee Prosthetic Surgery

Post-operative analgesia after total knee arthroplasty (TKA) has always been a challenge in the anesthesiological setting, having to combine good pain control and the need for early mobilization, both factors that can affect the quality of rehabilitation treatment, prosthetic functional outcome, the onset of chronic pain, joint stiffness and the consequent quality of life of the patient. Recent loco-regional anesthesia (LRA) techniques have made an essential contribution to peri-operative management in the fast-track perspective of surgery, in terms of optimization of analgesia and rapid functional recovery. Inadequate post-operative analgesia, by affecting the normal rehabilitation pathway, is associated with medium-long term complications, such as chronic pain, joint stiffness and patient dissatisfaction, which often compromise functional autonomy and quality of life of the patient and may require invasive treatments (surgical revision, unlocking under general anesthesia). The local and systemic inflammatory state, evidenced by peri-operative dosage of specific biomarkers, appears to be related to prosthetic outcome.

The Perioperative Outcome of Epinephrine Infusion and Tranexamic Acid in Knee Arthroplasty Surgery

The aim of this clinical trial is to evaluate the effect of administering low-dose epinephrine and tranexamic acid on perioperative blood loss, thromboembolic complications, and hospitalization duration in patients undergoing knee joint arthroplasty. Also aim to evaluate the effect of administering low-dose epinephrine and tranexamic acid on perioperative thromboembolic complications, and hospitalization duration

Comparative Analgesic Effect After Total Knee Arthroplasty Between Intraosseous and Peri-articular Injection

The goal of this RCT is to compare analgesic effect after total knee arthroplasty between intraosseous multimodal analgesic agent injection versus periarticular injection. The main question\[s\] it aims to answer are: Does Intraosseous multimodal analgesic cocktail injection have more post-operative analgesic effect than Peri-articular injection in patients who have done TKA (P)? Participants will randomized to intraosseous injection group or peri-articular injection group and will record the 100-mm VAS pain scores for 2 weeks after TKA. Researchers will compare to peri-articular injection group to see pain and functional outcomes after TKA.

The Effect of Kinesio Taping on Mobility, Pain, Balance and Daily Activities in Total Knee Replacement Patients

Total knee arthroplasty (TKA) is a surgical procedure performed to relieve pain and functional limitations caused by advanced gonarthrosis that cannot be managed with conservative methods. It is known that the postoperative rehabilitation program plays a crucial role in functionality and mobility in the postoperative period. Pain and swelling are the most commonly reported minor complications that lead to functional limitations, often associated with decreased muscle strength. After TKA, various current methods such as compression therapy and electrotherapy are employed to treat postoperative edema. Typically, patients are discharged with a home exercise program once they are ambulatory. However, the return to daily living activities varies among patients, and some may experience prolonged recovery times. In our country and hospital, there is no standardized algorithm for postoperative care following TKA. Patients are often referred to rehabilitation clinics only when complications arise. Due to issues with patient ambulation, there may be a need for inpatient care following TKA. While traditional rehabilitation programs are used, alternative methods to facilitate early ambulation have emerged in recent years, one of which is kinesiology taping (KT). Developed by Kenso Kase in the 1970s, KT is an elastic, wave-textured, waterproof, breathable cotton tape applied directly to the skin. When applied with various techniques, it helps alleviate pain, reduce edema, and provides mechanical support and joint protection. KT does not restrict movement; instead, its elastic structure opens the space between the dermis and fascia, aiding lymphatic and blood flow, thereby reducing swelling in the extremities. There are studies on the use of KT in postoperative patients beyond musculoskeletal pain conditions, particularly regarding its effectiveness in managing pain, swelling, and joint range of motion after shoulder and anterior cruciate ligament surgeries. Although recent studies in the literature have explored the use of KT after TKA, there is still no consensus on its efficacy and application methods. This study aims to investigate the potential effects or complications of KT treatment on balance, pain, mobility, and quality of life in patients undergoing rehabilitation after TKA.

Comparison of Restricted Versus Unrestricted Kinematic Alignment in 1ry TKA

Knee osteoarthritis is a growing socioeconomic burden because of the ageing and obesity. By 2030, the majority of individuals undergoing knee arthroplasty in USA will be those younger than 65 years, with up to 1 million achieved annually. The definitive treatment for knee joint degeneration is total knee arthroplasty.

Prospective, In-Vivo, Post-Market Safety and Efficacy Surveillance Registry of the MAXX Orthopedics, Freedom Total Knee® System

In an effort to satisfy regulatory requirements for post-market surveillance of product safety and efficacy, a representative sample of patients will be recruited for prospective monitoring.