Knee Arthroplasty

10

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

Condition / disease
Location
Status: Recruiting

Development of an Outcome Score for Patients With Knee Osteoarthritis and Knee Joint Endoprosthesis Using an App

Total knee arthroplasty (TKA) and total hip arthroplasty (THA) is one of the most frequent orthopedic procedures. Over 50% of patients report higher expectations than their surgeons, and 10-50% remain dissatisfied postoperatively. Persistent pain, functional limitations, and unmet expectations are key drivers. Identifying risks pre- and early postoperatively is essential, alongside empowering patients through self-management. Existing scoring systems integrate PROMs, demographics, and sometimes imaging but within limited timeframes. They rarely capture functional deficits or long-term trajectories. Digital health solutions for TKA (pre-)rehabilitation exist, yet most focus on physiotherapy and education rather than predictive outcome modeling. To address this gap, the study team has developed a novel mobile application that enables the documentation and analysis of movement data up to 10 years before surgery and throughout long-term follow-up. These data are combined with PROMs and functional test results, providing a unique basis for outcome prediction and risk stratification in TKA/THA. Primary Objective The aim of this pilot study is to develop a composite outcome score for TKA/THA patients. This score will integrate demographic variables, PROMs, and objective functional measures (knee joint angles, gait parameters, walk tests) to identify risk factors for dissatisfaction and support predictive modeling. A machine learning algorithm will be trained using the collected dataset to predict patient satisfaction after TKA/THA. Endpoints Primary endpoint: Overall patient satisfaction Secondary endpoints: Age, height, weight, step count, step length, gait asymmetry, gait speed, double support phase, knee joint ROM, walk test, KOOS, SF-36, EQ5d, satisfaction with the app, and satisfaction with app use. Study Population App-Group: Inclusion criteria are patients ≥18 years before or after TKA/THA. Exclusion criteria include missing consent, ineligible diagnosis, lack of smartphone, age \<18 years, or insufficient German language skills (as no English version of the app is currently available). Planned enrollment: 450 patients. Non-App-Group: Inclusion criteria are patients ≥18 years before or after TKA/THA. Exclusion criteria include missing consent, ineligible diagnosis, age \<18 years, or insufficient German language skills (as no English version of the app is currently available). Planned enrollment: 450 patients. Healthy-group: Inclusion criteria are healthy proband ≥18 years with no lower limb conditions. The overall procedure is identical to that of the AppGroup. Exclusion criteria include missing consent, ineligible diagnosis, no smartphone, age \<18 years, or insufficient German language skills (as no English version of the app is currently available). Planned enrollment: 450 patients. Methods Design: Single-center, prospective pilot study. The app collects patient-authorized movement data already stored on smartphones as well as future data. Participants choose which data to share. In addition, they are prompted to complete gait tests and knee function tests. PROMs (KOOS, SF-36, satisfaction) are administered at regular intervals.

Participants needed: 1,250
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Technical University of MunichUpdated: Apr 6, 2026Locations: 1
Eligibility criteria

aged 18 years or older [+3]

age below 18 years. [+3]

Status: Not yet recruiting

The Impact of Patient Education Delivered Through Virtual Reality

Objective: A randomized controlled trial was designed to determine the effect of virtual reality-based education provided to patients undergoing knee arthroplasty on preoperative surgical fear, postoperative pain, and patient satisfaction. Materials and Methods: The study was designed as a randomized controlled experimental study, with the group receiving animation-based patient education via virtual reality goggles serving as the experimental group and the group receiving routine patient education at the clinic serving as the control group. Research data will be collected using a patient characteristics form prepared by the researcher based on a literature review, a surgical fear scale, a visual analog scale, and a patient education satisfaction scale. Virtual reality glasses will be used as the application tool in the study.

Participants needed: 70
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Ankara Yildirim Beyazıt UniversityUpdated: Jan 22, 2026
Eligibility criteria

Be 18 years of age or older, [+4]

Bilateral Total Knee Arthroplasty. [+1]

Status: Not yet recruiting

Knee Arthroplasty Recovery With Transcranial Direct Current Stimulation

Total knee arthroplasty (TKA) is widely performed to reduce pain from advanced osteoarthritis, yet many patients experience severe postoperative pain and up to 25-44% develop chronic postsurgical pain (CPSP). Transcranial direct current stimulation (tDCS), a non-invasive neuromodulation technique, has shown promise in reducing pain and opioid use in early studies but has not been evaluated using comprehensive perioperative, home-based protocols. This study will test whether a home-based tDCS intervention delivered before and after TKA can improve acute pain management and reduce the development of CPSP.

Participants needed: 70
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Women's College HospitalUpdated: Jan 20, 2026Locations: 1
Eligibility criteria

18 years of age or older. [+3]

History of brain surgery, central nervous system tumors, seizures (including epi... [+22]

Status: Not yet recruiting

Effectiveness, Satisfaction, and Usability of Virtual Reality in the Management of Postoperative Pain in Patients Undergoing Knee Arthroplasty

The goal of this clinical trial is to evaluate the effectiveness of using virtual reality glasses to reduce the need for rescue analgesia in patients with acute postoperative pain after knee arthroplasty. The main questions it aims to answer are: * What is the impact of virtual reality use on postoperative pain perception as measured by the Visual Analogue Scale (VAS)? * What potential adverse effects are associated with the use of virtual reality in the postoperative context? * What is the level of satisfaction and acceptance of virtual reality as a complementary strategy for pain management? * How does virtual reality influence quality of life and psychosocial variables in patients with acute postoperative pain after knee arthroplasty?

Participants needed: 45
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Universidad Francisco de VitoriaUpdated: Dec 16, 2025
Eligibility criteria

Adults ≥18 years of age, both sexes [+3]

Neurological or psychiatric disorders (history of epilepsy, seizures, psychosis,... [+6]

Status: Not yet recruiting

The Effect of Rehabilitative Nursing Care Practices on Frail Patients Undergoing Knee Arthroplasty and Their Caregivers

This study was designed to holistically examine the effects of curative nursing care practices based on human caring theory on frail patients and their caregivers undergoing knee arthroplasty.

Participants needed: 50
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Ataturk UniversityUpdated: Oct 1, 2025Locations: 1
Eligibility criteria

Literate [+6]

Developing serious surgical complications (e.g., infection, embolism, prosthesis... [+7]

Status: Recruiting

Effect of Music Listened During Knee Arthroplasty With Spinal Anesthesia on Anxiety, Pain and Cortisol Levels

The aim of this study is to examine the effects of binaural beat music played during spinal anesthesia knee arthroplasty on anxiety, pain and cortisol levels. The study was planned as a randomized controlled experimental design study. The hypotheses of the study are as follows; * Binaural beat music played during spinal anesthesia knee arthroplasty has no effect on anxiety. * Binaural beat music played during spinal anesthesia knee arthroplasty has an effect on anxiety. * Binaural beat music played during spinal anesthesia knee arthroplasty has no effect on pain levels. * Binaural beat music played during spinal anesthesia knee arthroplasty has an effect on pain levels. * Binaural beat music played during spinal anesthesia knee arthroplasty has no effect on cortisol levels. * Binaural beat music played during spinal anesthesia knee arthroplasty has an effect on cortisol levels. A sample group will be formed with 20 patients in the intervention group and 20 patients in the control group. Binaural beat music will be played in the intervention group during the surgical procedure, and routine interventions will be applied to the control group. Data collection in the intervention group is as follows; * Patients will be interviewed in the surgery clinic before surgery and the descriptive characteristics form and the State Anxiety Inventory Form will be filled out. * The 1st measurement of hemodynamic data will be recorded immediately before the surgery * A musical concert will be started as soon as the surgery begins * The musical concert will end when the surgery ends * The 2nd measurement will be recorded immediately after the surgery ends * In the post-surgery collection unit, the State Anxiety Inventory Form and the Visual Comparison Scale will be used, and a blood sample will be taken to determine cortisol values. The control group data collection methods are as follows; * Patients will be interviewed in the surgical clinic before surgery and the descriptive characteristics form and the State Anxiety Inventory Form will be filled in * The first measurement of hemodynamic data will be recorded immediately before the surgical procedure * The second measurement will be recorded immediately after the surgical procedure is completed * Blood samples will be taken in the post-surgical recovery unit to determine the State Anxiety Inventory Form, Visual Comparison Scale and cortisol values.

Participants needed: 40
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Nuh Naci Yazgan UniversityUpdated: Aug 20, 2025Locations: 1
Eligibility criteria

Patients who are older than 18 years, [+5]

Patients who refused to participate in the study were those with hearing impairm... [+5]

Status: Not yet recruiting

Risk of Serious Adverse Events Following Unsupervised vs Supervised Rehabilitation After Knee Arthroplasty

SUMMARY Background: After knee arthroplasty (KA), rehabilitation is widely recommended, yet its clinical effectiveness-especially the need for supervision-has been challenged. While some argue that supervised rehabilitation may prevent serious adverse events (SAEs), previous trials show no superiority of rehabilitation, supervised or not, over no rehabilitation in terms of function. However, these trials were underpowered for safety outcomes. A large-scale evaluation is needed to determine if supervision impacts SAE risk, thereby informing rational use of health care resources. Rationale for the proposed study. A conventional randomized trial to assess the safety of supervised versus unsupervised rehabilitation after KA would require an ethically and logistically infeasible sample size. By emulating such a trial using routinely collected registry data, the investigators can estimate the causal effect of supervision on the risk of serious adverse events-while accounting for confounding and preserving real-world relevance. Actionable objective and hypothesis: To test whether unsupervised rehabilitation after knee arthroplasty increases the risk of serious adverse events over a 2-year period compared with supervised rehabilitation. The investigators hypothesize that unsupervised rehabilitation is non-inferior, defined as a hazard ratio for SAE risk below 1.4. Design: Target trial emulation (TTE) using nationwide registry data to replicate the design and intent of a pragmatic randomized trial. Setting: Danish hospitals and municipalities. Patients: Adults undergoing primary total or unicompartmental knee arthroplasty for osteoarthritis, identified from Danish registries. The target trial assumes consecutive recruitment at hospital discharge to mirror real-world referral practices. Interventions: Referral to unsupervised home-based exercise or supervised municipal physiotherapy, defined by referral to rehabilitation pathways initiated at hospital discharge. Methods: Primary outcome is serious adverse events; secondary is number of hospital contacts. Propensity score-based weighting will adjust for confounding using patient and administrative covariates (e.g. age, BMI, comorbidities, surgery year), enabling causal inference from observational data. Results: Findings will inform clinical practice by estimating the comparative safety of unsupervised versus supervised rehabilitation after knee arthroplasty, based on real-world data from over 40,000 patients. Limitations: As with all non-randomized studies, residual confounding is possible. Despite adjustment strategies, causal interpretations should be made with caution due to reliance on observational data. Conclusion: While TTE can provide valuable insight, the causal inferences made with TTE should be interpreted with caution, when not supported with an RCT. Funding: Section for Biostatistics and Evidence-Based Research, the Parker Institute, Bispebjerg and Frederiksberg Hospital is supported by a core grant from the Oak Foundation (OFIL-24-074). External funding: in process. Registration: TBD (registration on ClinicalTrials.Gov)

Participants needed: 40,000
Trial details
Biological sex: AllType: ObservationalSponsor: Copenhagen University Hospital, HvidovreUpdated: Jul 31, 2025Duration: 2 Years
Eligibility criteria

Adults undergoing primary total or unicompartmental knee arthroplasty (KA) for o...

None

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: May 14, 2025Locations: 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: May 14, 2025Locations: 2
Eligibility criteria

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

Refusal of consent [+13]

Status: Not yet recruiting

The Dubousset Functional Test in Total Knee Arthloplasty

The aim of this study is to investigate the validity and reliability of Dubousset Functional Test in the patients with Total Knee Prothesis.

Participants needed: 60
Trial details
Age: 50-70Biological sex: AllType: ObservationalSponsor: Alanya Alaaddin Keykubat UniversityUpdated: Oct 9, 2024
Eligibility criteria

Patients who had Total Knee Arthroplasty [+1]

Patients who didn't have any Total Kne arthroplasty [+1]