Osteoarthritis, Hip Clinical Trial
Official title:
The ACTIVE Trial: A Prospective Randomised Control Trial Of The H1 Implant Versus Total Hip Replacement
The goal of this randomised controlled trial is to compare the success of two types of hip replacement in patients with hip arthritis. The main question it aims to answer is whether a new type of hip replacement (called a hip resurfacing) can be as successful as an existing hip replacement (called a total hip replacement). Patients will be given either the new hip resurfacing or the existing total hip replacement and researchers will compare their function, complication rate and physical activity.
The H1 Implant is a cementless, ceramic hip resurfacing arthroplasty (HRA) device. The intended purpose of the H1 Implant is to provide an artificial substitute for a disease-damaged hip joint to replace the articulating surfaces of the hip while preserving the underlying femoral head and natural femoral neck. This is standard for a resurfacing hip prosthesis. This study will randomise patients to receive either The H1 Implant or a primary cementless ceramic-on-poly or ceramic-on-ceramic total hip replacement (THR). Composite clinical success (CCS) scores, physical activity levels and patient reported outcome measures (PROMs) will be compared for the two groups. The primary objective of the study is to determine whether the H1 Implant is non-inferior to cementless THR in terms of CCS. The key secondary objective is to determine whether the H1 Implant is superior compared to cementless THR in terms of physical activity and PROMs. Other secondary objectives are to compare the H1 Implant and THR with respect to: safety, through collection of all device-related, operative site-related and systemic adverse events; and noise generation, through patient survey. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT05773261 -
Clinical Investigation Comparing Two Different Ultra-porous Coated Surfaces of Uncemented Cups
|
N/A | |
| Recruiting |
NCT05223777 -
KINCISE™ Surgical Automated System in Total Hip Arthroplasty (THA)
|
N/A | |
| Recruiting |
NCT04731077 -
Avenir Complete Post-Market Clinical Follow-Up Study
|
N/A | |
| Not yet recruiting |
NCT04448106 -
Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs) for Osteoarthritis
|
Phase 2 | |
| Completed |
NCT05070871 -
A Clinical Trial Investigating the Effect of Salmon Bone Meal on Osteoarthritis Among Men and Women
|
N/A | |
| Withdrawn |
NCT02743208 -
Evaluation of a Short Femoral Stem in Total Hip Arthroplasty
|
N/A | |
| Completed |
NCT02944448 -
A Study Evaluating Pain Relief and Safety of Orally Administered CR845 in Patients With Osteoarthritis of Hip or Knee
|
Phase 2 | |
| Active, not recruiting |
NCT02229279 -
Evaluation of Teleconsulting on Rehabilitation After Hip and Knee Surgical Procedures
|
N/A | |
| Active, not recruiting |
NCT02851992 -
A Prospective Study to Evaluate Long-term Clinical Outcomes of the GTS Cementless Femoral Stem
|
N/A | |
| Completed |
NCT01618708 -
A Study of the Safety and Effectiveness of Synvisc-One® (Hylan G-F 20) in Patients With Primary Osteoarthritis of the Hip
|
N/A | |
| Completed |
NCT01700933 -
Dose-response: Exercise Therapy on Hip Osteoarthritis
|
N/A | |
| Completed |
NCT01214954 -
Early Rehabilitation After Total Hip Replacement
|
N/A | |
| Active, not recruiting |
NCT00294424 -
Study on Costs and Effects of Waiting Time in Total Hip and Knee Replacements
|
N/A | |
| Terminated |
NCT00588861 -
Total Hip Replacement With the Answer® Hip Stem and Ranawat/Burnstein® Shell Using Simplex® or Palacos® Bone Cement
|
N/A | |
| Withdrawn |
NCT05054595 -
Audio-Recorded vs. Nurse-Led Brief Mindfulness-Based Intervention
|
N/A | |
| Terminated |
NCT00973141 -
A Dose-ranging Study of the Safety and Effectiveness of JNJ-42160443 as add-on Treatment in Patients With Osteoarthritis-related Pain
|
Phase 2 | |
| Recruiting |
NCT05014113 -
H-28 DELTA ST-C and Minima Retrospective Study.
|
||
| Completed |
NCT01066936 -
Mini Stem DEXA (Dual Energy X-ray Absorptiometry)
|
||
| Recruiting |
NCT06185036 -
Histological Validation of dGEMRIC Indices as a Quantitative Biomarker for Cartilage Damage in the Hip Joint
|
||
| Recruiting |
NCT05530551 -
Effect of Single vs Multiple Prophylactic Antibiotic Doses on PJI Following Primary THA in Patients With OA
|
N/A |