Clinical trials: PROMs
Knee Arthroplasty, Total
Evaluation of Navigation-Assisted TKA Using Mechanical vs. Restricted Kinematic Alignment
The purpose of this study is to evaluate both clinical measures and PROMs in patients undergoing total knee arthroplasty (TKA) using restricted inverse kinematic alignment (iKA) compared to mechanical alignment (MA), both using…
- Trial name
- NCT05516381
- Testing
- Optetrak Logic CR Knee System
- Where
- Spain
- Volunteers
- 148 people, healthy volunteers welcome
- Sponsor
- Exactech
Arthritis (E.G., Degenerative Joint Disease (DJD), Osteoarthritis, and Rheumatoid Arthritis (RA))
A Prospective, Pre-market, Multi-center Study of Insignia Hip Stem in THA to Determine Implant Survivorship and PROMS.
The purpose of this study is to evaluate the survivorship (revision rates) and patient reported outcomes (PROMs) following implantation of the Insignia hip stem in patients undergoing cementless total hip replacement surgery…
- Trial name
- NCT06108934
- Testing
- Hip stem prosthesis
- Where
- Australia
- Volunteers
- 313 people
- Sponsor
- Stryker Australia Pty Ltd.
Peripheral Artery Disease
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Open label, real-world, prospective, multi-center, single arm, post-market surveillance study of the SELUTION SLR™ (Sustained Limus Release) drug eluting balloon (DEB).
- Trial name
- SUCCESS PTA (NCT04776434)
- Testing
- SELUTION SLR™ (Sustained Limus Release) drug eluting balloon (DEB)
- Where
- 27 sites in Argentina, Germany and 6 more
- Volunteers
- 723 people
- Sponsor
- M.A. Med Alliance S.A.
COPD
Impact of Fixed TRIple Therapy With Beclometasone/Formoterol/Glycopyrronium DPI (Trimbow® in NEXThaler Device) in Chronic Obstructive PulmoNary Disease in rEal-world Settings: Health-related Quality of Life Patient' eXpectations and characterisTics: the TriNEXT Study
This is an observational, prospective, multicentric, cohort study conducted in France to evaluate the QoL in COPD patients treated with TRIMBOW NEXThaler 88/5/9 in a routine clinical practice setting.
- Trial name
- TriNEXT (NCT05948891)
- Testing
- Beclometasone/Formoterol/Glycopyrronium 88 µg/5 µg/9 µg DPI (Trimbow® 88 µg/5 µg/9 µg in NEXThaler device)
- Where
- France
- Volunteers
- 500 people
- Sponsor
- Chiesi SAS
Hip Arthritis, Osteoarthritis, Hip
Observational Study to Collect Safety Data and PROMs on Primary THA
This observational study is designed to collect safety data and PROMs on retrospective primary total hipa arthroplasty surgeries with Trinity cup and Meije Duo cementless hip system
- Conditions
- Hip Arthritis, Osteoarthritis, Hip, Coxitis, Femoral Head Necrosis
- Trial name
- NCT06518993
- Testing
- Total hip arthroplasty with a Trinity cup and a Meije Duo cementless stem
- Where
- France
- Volunteers
- 116 people
- Sponsor
- Corin
Knee Arthroplasty, Patient Engagement
Limited Market Release - MotionSense Clinical Use Evaluation
Prospective evaluation of patient compliance and prescribed home exercise program using MotionSense wearable system during recovery from primary total knee arthroplasty.
- Conditions
- Knee Arthroplasty, Patient Engagement, Patient-Reported Outcome Measures (PROMs)
- Trial name
- FS5 (NCT05091918)
- Testing
- MotionSense
- Where
- 2 sites in United States
- Volunteers
- 101 people
- Sponsor
- Orthosensor, Inc.
Osteoarthritis, Knee, Edema Leg
The Post-operative Effect on Formation of Oedema After Total Knee Arthroplasty With or Without the Use of a Nerve Stimulator (the gekoTM Device)
This study will investigate whether the recovery of muscle function of total knee arthroplasty is accelerated with the use of the gekoTM device along with its effect on reducing symptoms such as oedema and inhibition of the…
- Conditions
- Osteoarthritis, Knee, Edema Leg, Joint Diseases, Rehabilitation
- Trial name
- NCT05042492
- Testing
- gekoTM
- Where
- Belgium
- Volunteers
- 60 people
- Sponsor
- moveUP bv
Osteoarthritis, Knee and Hip
Change in Patient Reported Outcomes and Wish for Joint Surgery
Aim To investigate associations between within-person change in patient reported outcomes (PROMs) and wish for joint surgery during up to 12-month participation in a digital first-line intervention for knee and hip osteoarthritis…
- Trial name
- NCT05455177
- Testing
- Digital first-line intervention for osteoarthritis including exercise and education
- Where
- Sweden
- Volunteers
- 14,018 people
- Sponsor
- Joint Academy
Oral Mucositis, Quality of Life
Effect of a Novel Topical Composition on the Incidence of Severe Oral Mucositis in Head & Neck Cancer Radiated Patients and Quality of Life Assessed by PROMs.
The use of a novel topical mucosa composition (XCM-OM118) comprising 2-(trimethylazaniumyl) acetate; (2R,3R,4S)-pentane-1,2,3,4,5-pentol; Hexadecanoic acid; (9Z, 12Z)-octadeca-9,12-dienoic acid; octadecanoic acid…
- Conditions
- Oral Mucositis, Quality of Life, Mucositis, Pain
- Trial name
- STOPOMP (NCT05635929)
- Testing
- XCM-OM118 Composition comprising olive oil, betaine and xylitol
- Where
- Spain
- Volunteers
- 63 people
- Sponsor
- Mucosa Innovations, S.L.
Vulvar Atrophy, Vulvovaginal Signs and Symptoms
Changes in the Impact of Genitourinary Syndrome of Menopause With a Novel Nonhormonal Vulvovaginal Gel Assessed by PROMs.
The goal of this clinical trial is to improve the management of Genitourinary syndrome of menopause (GSM) to preliminary assess safety and effectivity of a novel hormone-free mucosa composition (XCMIM20m) applied topically to the…
- Conditions
- Vulvar Atrophy, Vulvovaginal Signs and Symptoms, Genitourinary Syndrome of Menopause, Quality of Life
- Trial name
- STOPGSMP (NCT06962345)
- Testing
- Hormone-free vulvovaginal gel with the tested composition XCMIM20m
- Where
- Spain
- Volunteers
- 80 people
- Sponsor
- Mucosa Innovations, S.L.