Total Knee Replacement

22

Review clinical trials related to Total Knee Replacement. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

Suzetrigine in TKA

Total knee replacements are among the most common and painful orthopedic procedures performed worldwide, often requiring intensive analgesia to support early ambulation and recovery. Despite widespread use of multimodal regimens, many patients still rely on opioids, which can cause sedation, nausea, constipation, and long-term dependency. Evaluating suzetrigine in this high-need population may improve recovery trajectories, reduce opioid consumption, and support enhanced recovery protocols. Given the growing surgical volume and the emphasis on opioid-sparing strategies, rigorous investigation of suzetrigine's efficacy in total knee replacement is of high clinical value. In this confirmatory (phase III) trial, patients undergoing primary total knee replacement will be randomized to receive either suzetrigine or placebo for 2 weeks (14 days), with the loading dose administered prior to surgery. The primary outcome is cumulative 48-hour opioid consumption in oral morphine equivalents starting from entry into the post-anesthesia care unit (PACU).

Participants needed: 148
Trial details
Phase: Phase 3Age: 18-80Biological sex: AllType: InterventionalSponsor: Hospital for Special Surgery, New YorkUpdated: Oct 13, 2026Locations: 1
Eligibility criteria

Patients undergoing primary TKA with participating surgeons [+5]

ASA greater than 3 [+15]

Status: Recruiting

Binaural Beats for Postoperative Pain and Anxiety Reduction

To deliver a 30-minute binaural beats audio intervention in PACU and collect pain and anxiety outcomes immediately following surgery, and 4 hours following surgery completion in adults undergoing ambulatory total knee arthroplasty and total hip arthroplasty (TKA and THA).

Participants needed: 50
Trial details
Age: 18-99Biological sex: AllType: InterventionalSponsor: University of MiamiUpdated: Sep 30, 2026Locations: 1
Eligibility criteria

American Society of Anesthesiologists Physical Status Classification System (ASA... [+3]

Moderate-severe hearing impairment or use of hearing aids [+3]

Status: Recruiting

Comparison of the Effects of Apixaban on Thrombin Generation in Patients With de Novo Multiple Myeloma

Patients with multiple myeloma (MM) are at high risk of venous thromboembolism (VTE) and these patients require adequate thromboprophylaxis. Following the publication of the AVERT clinical study, Apixaban is strongly recommended as a prophylactic treatment option for patients with cancer, based on high quality of evidence and a favorable efficacy/safety profile. A multicenter and ancillary study - APIXABOR - that measured the plasmatic concentration of Apixaban in patients with MM and treated with preventive dose has been conducted. The peak drug concentration was superior in MM plasma, as compared to non-myeloma patients under prophylaxis. Therefore, the present study evaluated whether differences in pharmacokinetics have an impact on pharmacodynamics (i.e. decrease in coagulability in MM patients as compared to non-MM patients undergoing a surgery for total knee replacement who also have VTE prophylaxis). In fine, this study may inform to better manage thromboprophylaxis in MM patients.

Participants needed: 36
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Centre Hospitalier Universitaire de Saint EtienneUpdated: Sep 21, 2026Locations: 1
Eligibility criteria

Age ≥ 18 years old, [+4]

Curative doses of anticoagulation treatment, [+4]

Status: Recruiting

Femoral Component TKA: Extramedullary vs Conventional Intramedullary Guide

The study wants to evaluate the performance of this EM guide in comparison to a traditional IM guide. 75 patients will be included in the extramedullary group (to be compared with a corresponding previous group of 75 patients treated with intramedullary guide).

Participants needed: 150
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUpdated: Sep 11, 2026Locations: 3
Eligibility criteria

Male or female ≥ 18 years old [+3]

Revision surgery of knee arthroplasty [+4]

Status: Recruiting

A Study to Compare Different Ways of Steroid Administration After Total Knee Implantation

We are going to evaluate the difference between perioperative intravenous steroid supplementation, perioperative periarticular steroid supplementation, and standard anaesthesia protocols. We'll evaluate the outcome of patients with knee osteoarthritis who are undergoing Total Knee Arthroplasty to understand which of the three treatments give more benefits to the patient.

Participants needed: 159
Trial details
Phase: Phase 4Age: 50-85Biological sex: AllType: InterventionalSponsor: Christian CandrianUpdated: Sep 11, 2026Locations: 1
Eligibility criteria

Patients undergoing unilateral primary TKA at the Ospedale Regionale di Lugano. [+3]

Contraindications to steroids. [+10]

Status: Recruiting

Dressing-related Experiences and Surgical Site Self-care in Hip and Knee Replacement: an Observational Cohort Study

The goal of this prospective observational cohort study is to investigate dressing-related experiences and surgical site self-care in patients who are undergoing a total hip or knee replacement. The main objectives of the study are: * To evaluate patient adherence to the ISWCAP self-care checklist after total hip or knee replacement within an ERAS pathway. * To explore patient-reported outcomes related to the performance and comfort of advanced dressings. * To assess the perceived adequacy and usefulness of post-discharge wound care education. * To identify the incidence and types of wound-related complications in the 12 weeks following surgery. Participants will give informed consent before surgery and will start the study once the dressing has been applied following surgery. There will be follow up study visits at discharge, 7 days, 12 days, 6 weeks and 12 weeks post-surgery. Data relating to vital signs, medical history, surgery and medication will be taken from routine data.

Participants needed: 100
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Bournemouth UniversityUpdated: Aug 24, 2026Locations: 2
Eligibility criteria

Adults (18+) undergoing primary total hip or knee replacement [+2]

Requiring revision replacement [+2]

Status: Recruiting

Yale Steroid Enhanced Versus Exparel Nerveblock TKA Part 2

The objective of this study is to investigate the efficacy of Dexamethasone sodium phosphate plus Methylprednisolone acetate in combination with plain bupivacaine ((B-DEX-MPA) compared with Liposomal Bupivacaine in combination with plain bupivacaine (B-LB) on post-surgical pain control among patients undergoing bilateral total knee arthroplasty (TKA) to asses if perineural B-DEX-MPA will result in superior analgesia efficacy as compared to B-LB. This study will also assess if perineural B-DEX-MPA results in improved quality of postoperative recovery as compared to B-LB.

Participants needed: 66
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Yale UniversityUpdated: Jul 23, 2026Locations: 2
Eligibility criteria

American Society of Anesthesiologists status I, II and III, elective, primary, b...

Refusal of consent [+13]

Status: Recruiting

Yale Steroid Enhanced Versus Exparel Nerveblock TKA RCT Study

The objective of this phase 2 study is to investigate the efficacy of Dexamethasone sodium phosphate (DEX) plus Methylprednisolone acetate (MPA) in combination with plain bupivacaine (B) compared with Liposomal Bupivacaine (LB) in combination with plain bupivacaine on post-surgical pain control among patients undergoing unilateral total knee arthroplasty (TKA) to asses if perineural B-DEX-MPA will result in superior analgesia efficacy as compared to B-LB. This study will also assess if perineural B-DEX-MPA results in improved quality of postoperative recovery as compared to B-LB.

Participants needed: 250
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Yale UniversityUpdated: Jul 23, 2026Locations: 2
Eligibility criteria

American Society of Anesthesiologists status I, II and III, elective, primary, u...

Refusal of consent [+13]

Status: Not yet recruiting

Digitally Supported Short-Term Prehabilitation Before Total Knee Replacement

This study evaluates the feasibility of a short-term, digitally supported prehabilitation program for patients scheduled for elective total knee replacement (TKR). Osteoarthritis is a leading cause of disability, and recovery following TKR remains heterogeneous, with a substantial proportion of patients experiencing delayed functional recovery. Prehabilitation may improve perioperative outcomes, but its implementation is often limited by short preoperative time windows. The Prehab2Rehab-KneeTEP trial is a single-center, two-arm, randomized controlled feasibility study conducted in Austria. Patients will be randomized (1:1) to either a multimodal video-supported prehabilitation program or usual care. The intervention consists of a 10 to 14-day preoperative exercise program including strength, endurance, coordination, and gait training, supported by a digital application, and is complemented by a digitally supported transition phase after hospital discharge until the start of inpatient rehabilitation. The primary objective is to assess feasibility in terms of recruitment, retention, adherence, fidelity, acceptability, and safety. Secondary exploratory outcomes include clinical recovery indicators, functional performance, and patient-reported outcomes assessed across the perioperative pathway.

Participants needed: 60
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Ludwig Boltzmann Institute for Digital Health and PreventionUpdated: Jul 14, 2026Locations: 1
Eligibility criteria

Age ≥18 years at the time of enrolment. [+7]

Pregnancy at the time of enrolment. [+5]

Status: Not yet recruiting

Circulatory Exercise After Total Knee Replacement

Total knee replacement is commonly associated with early postoperative inflammation, edema, pain, and reduced mobility. This randomized controlled trial will evaluate whether adding a simple circulatory exercise program to standard postoperative rehabilitation reduces early limb edema and inflammatory response after unilateral primary total knee replacement. Participants will be randomized to standard rehabilitation alone or standard rehabilitation plus seated and supine knee-extension exercises with alternating ankle dorsiflexion. The primary endpoint is change in limb edema measured by standardized limb circumference at postoperative day 14.

Participants needed: 68
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Assiut UniversityUpdated: Jul 7, 2026
Eligibility criteria

Adults ≥ 18 years undergoing elective unilateral primary TKR for osteoarthritis. [+2]

Preexisting peripheral vascular disease with severe ischemia or venous insuffici... [+3]

Status: Recruiting

Effect of Physical Therapy Rehabilitation on Gait and Plantar Pressure in Patients After Total Knee Replacement

This study aims to investigate the effects of a structured physical therapy and rehabilitation program on gait temporospatial parameters and plantar pressure distribution in patients who have undergone total knee replacement surgery. Patients undergoing total knee replacement often experience alterations in gait patterns and weight distribution, which may affect functional mobility and recovery outcomes. This study will evaluate whether a targeted rehabilitation program can improve walking performance and restore more symmetrical plantar pressure distribution. Participants will be assessed before and after the intervention using objective gait analysis and plantar pressure measurement tools. The findings of this study may help improve rehabilitation strategies and enhance functional recovery following knee replacement surgery.

Participants needed: 30
Trial details
Age: 40-70Biological sex: FemaleType: InterventionalSponsor: Jouf UniversityUpdated: Apr 29, 2026Locations: 1
Eligibility criteria

Female participants aged between 40 and 70 years [+3]

Neurological disorders affecting gait (e.g., stroke, Parkinson's disease) [+4]

Status: Recruiting

Mako Cementless TKA vs Mako Cemented TKA

The overall aims of this prospective, randomised, single-blinded controlled trial are to compare functional, radiological and clinical outcomes in Mako robotic-arm assisted cementless Total Knee Arthroplasty (TKA) versus Mako robotic-arm assisted cemented TKA.

Participants needed: 120
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: University College, LondonUpdated: Feb 20, 2026Locations: 1
Eligibility criteria

Patient has symptomatic knee osteoarthritis requiring primary TKA [+6]

Patient is not suitable for routine primary TKA e.g. patient has ligament defici... [+9]

Status: Not yet recruiting

Cooling of the Knee After Total Knee Arthroplasty

This study investigates whether cooling the knee after total knee replacement surgery can reduce pain and improve early recovery. After surgery, patients are randomly assigned to one of three groups: cooling with a liquid cooling bandage, cooling with an ice pack, or standard postoperative care without cooling. Cooling begins 24 hours after surgery and continues for two weeks. Pain levels, use of pain medication, blood values, knee swelling, knee movement, and length of hospital stay are recorded. The goal is to determine whether postoperative knee cooling provides additional benefits compared with standard care.

Participants needed: 99
Trial details
Biological sex: AllType: InterventionalSponsor: Clinical Center of VojvodinaUpdated: Feb 18, 2026
Eligibility criteria

• Adults undergoing primary total knee arthroplasty [+4]

• Unregulated or poorly controlled diabetes mellitus [+2]

Status: Not yet recruiting

Analgesic Efficacy of Pre-Operative Dose of Palmitoylethanolamide in Patients Undergoing Total Knee Arthroplasty

Analgesic Efficacy of Pre-Operative Dose of palmitoylethanolamide in Patients Undergoing total Knee Arthroplasty, A Randomized Double-Blinded Controlled Trial.

Participants needed: 1
Trial details
Phase: Phase 1, Phase 2Age: 40-80Biological sex: AllType: InterventionalSponsor: Abdelrahman Gaber Sayed ElkhateebUpdated: Jan 9, 2026Locations: 1
Eligibility criteria

Rheumatoid Arthritis [+3]

Status: Recruiting

Total Knee Replacement Under Spinal Anesthesia, Comparison of Postoperative Recovery Versus General Anesthesia

Intraoperative anesthetic management for total knee replacement (TKR) can be performed under general or spinal anesthesia. These two techniques have their own characteristics and may impact postoperative recovery differently. However, there are no studies in the literature analyzing postoperative functional recovery after TKR surgery according to the type of anesthesia. The objective of this study is to compare postoperative recovery, assessed by the QoR-15F score, in patients undergoing TKR under spinal anesthesia versus surgery under general anesthesia.

Participants needed: 500
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: University Hospital, Strasbourg, FranceUpdated: Dec 10, 2025Locations: 1
Eligibility criteria

Male or female, 18 years of age or older (no upper age limit) [+2]

Subject (and/or their legal representative, if applicable) who expressed their o... [+1]

Status: Recruiting

Effects of Fall Prevention Program on the Number of Falls Among Elderly Following Total Knee Replacement

the aim of the proposed research is to investigate the short and long-term effects of integrating a comprehensive fall prevention programme into conventional physiotherapy on the number of falls, balance, and functional ability among elderly following TKR. the investigator hypothesize that conventional physiotherapy integrated with a fall prevention program is more effective than conventional physiotherapy alone in improving balance and functional ability and preventing the occurrence of falls among elderly following TKR. Study type: The proposed study is a parallel group prospective (24 weeks) randomised single-blinded pragmatic controlled trial. Participants: Older adults operated for TKR at Al-Razi orthopedic hospital, who met the inclusion criteria.

Participants needed: 90
Trial details
Age: 60+Biological sex: FemaleType: InterventionalSponsor: Ministry of Health, KuwaitUpdated: Dec 9, 2025Locations: 1
Eligibility criteria

Female gender. [+3]

revision TKR surgery [+6]

Status: Recruiting

TRabecular Metal Economic and Clinical Knee Trial

To compare the differences, if any, in clinical outcome, patient satisfaction and survivorship between cemented and uncemented Total Knee Replacements (TKR)? To investigate if there are health economic implications of using uncemented TKRs in the NHS?

Participants needed: 144
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: NHS Greater Glasgow and ClydeUpdated: Jun 25, 2025Locations: 1
Eligibility criteria

Male or female subjects may be recruited to the evaluation. [+5]

Patients who, in the opinion of the Investigator, have an existing condition tha... [+7]

Status: Recruiting

Movement Dynamics of Knee Osteoarthritis and Total Knee Replacement

This research aims to explore differences in walking and functional movement mechanics, exercise response, and physical activity between people with osteoarthritis (OA), those who have undergone total joint replacement, and healthy individuals.

Participants needed: 36
Trial details
Age: 40-85Biological sex: AllType: ObservationalSponsor: University of PortsmouthUpdated: Feb 21, 2025Locations: 1
Eligibility criteria

Diagnosed symptomatic bilateral or unilateral knee osteoarthritis, self-reported...

Unable to walk at 0.8 m/s, exclusion based on IMO screening, non-English speakin...

Status: Recruiting

Comparison of Pivotal Medial Polyethylene Versus Ultra-congruent in Total Knee Arthroplasty

The aim of this study is to compare the forgotten joint score for the medial pivot polyethylene and ultra-congruent polyethylene which are used in total prosthetic replacement of the knee

Participants needed: 90
Trial details
Age: 18-90Biological sex: AllType: InterventionalSponsor: University Hospital, Clermont-FerrandUpdated: Jan 17, 2025Locations: 1
Eligibility criteria

Subjects 18 to 90 years of age, eligible for a primary total knee replacement fo... [+2]

Infection history of the knee to be replaced [+7]

Status: Not yet recruiting

Remote Multichannel Monitoring of Patients With Chronic DIseAses Using Speech technoLogies Based On Artificial intelliGence

DIALOG is a study to assess the efficacy and safety of remote patient monitoring using virtual operator voice technologies and a business intelligence (BI) system for timely detection, prevention of early complications, worsening of the condition, and other adverse events in patients who have been discharged from the hospital.

Participants needed: 500
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: I.M. Sechenov First Moscow State Medical UniversityUpdated: Oct 16, 2024Locations: 1
Eligibility criteria

Disease diagnosed according to the latest Clinical practice guidelines [+6]

Unwillingness of the patient to continue participating in the study [+1]

Status: Recruiting

A Post-market Observational ORIGIN® CR Clinical Study

The study objective is to evaluate safety and performance of the ORIGIN® CR (cruciate retaining) devices and associated instruments, more precisely to evaluate safety by the proportion of patients requiring a revision (i.e. revision rate) at 1-year post procedure and to evaluate performance by means of a Knee Society Score (KSS) Knee Score at 1 year post procedure and by means of a KSS Function Score also at 1 year post procedure. The hypothesis raised for this study, regarding the scoring, is that patients will experience a marked improvement in the natural feel of the prosthesis during the first year after the surgery, and slightly significant improvement at the following interval of 2 years. The overall patient satisfaction is expected to be improved after 2 years follow-up with ORIGIN® CR.

Participants needed: 199
Trial details
Age: 18-99Biological sex: AllType: ObservationalSponsor: Symbios Orthopedie SAUpdated: Oct 8, 2024Locations: 2
Eligibility criteria

Male and female over 18 years of age [+4]

Acute or chronic, local or systemic infection [+15]

Status: Recruiting

The Effect of Abdominal Massage and Warm Application on Excretory Activity in Patients Undergoing Total Knee Replacement With Spinal Anesthesia

The aim of this study was to determine the effect of abdominal massage and warm application on the excretory activity (time of first bowel sounds, defecation time and the amount of laxative used until discharge) after total knee replacement surgery performed with spinal anesthesia.

Participants needed: 84
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Ayşe DemirtaşUpdated: Aug 30, 2024Locations: 2
Eligibility criteria

Written and verbal permission was obtained to participate in the study, [+8]

Written and verbal permission to participate in the research could not be obtain... [+8]