Osteoarthritis Clinical Trial
Official title:
Continuum™ Ceramic Bearing System in Total Hip Arthroplasty. A Multi-center, Prospective, Non-controlled Post Market Surveillance Study
Verified date | January 2024 |
Source | Zimmer Biomet |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The primary objective of this study is to obtain implant survivorship and clinical outcome data for the commercially available Zimmer® Continuum™ Ceramic-on-Ceramic Bearing System when used in primary hip arthroplasty. This will be done by analysis of standard scoring systems, radiographs and adverse event records. Data will be used to monitor pain, mobility and survivorship, and to confirm the safety and efficacy of the Continuum Ceramic-on-Ceramic Bearing System.
Status | Active, not recruiting |
Enrollment | 203 |
Est. completion date | September 2025 |
Est. primary completion date | July 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 75 Years |
Eligibility | Inclusion Criteria: - Patient is 21 to 75 years of age, inclusive. - Patient is skeletally mature. - Patient qualifies for primary unilateral or bilateral total hip arthroplasty (THA) based on physical exam and medical history including the following: - Avascular necrosis (AVN) - Osteoarthritis (OA) - Inflammatory arthritis (i.e. Rheumatoid arthritis) - Post-traumatic arthritis - Patient has no history of previous prosthetic replacement device (any type, including surface replacement arthroplasty, endoprosthesis, etc.) of the affected hip joint(s). - Patient has a Harris Hip Score <70 in the affected hip - Patient is willing and able to provide written informed consent. - Patient is willing and able to cooperate in the required post-operative therapy. - Patient is willing and able to complete scheduled follow-up evaluations as described in the Informed Consent. - Patient has participated in the Informed Consent process and has signed the Ethics Committee approved informed consent. Exclusion Criteria: - The patient is: - A prisoner - Mentally incompetent or unable to understand what participation in the study entails - A known alcohol or drug abuser - Anticipated to be non-compliant. - The patient has a neuromuscular disorder, vascular disorder or other conditions that could contribute to prosthesis instability, prosthesis fixation failure, or complications in postoperative care. - The patient has a vascular (large and small vessel disease) insufficiency. - The patient has a chronic renal impairment or failure. - The patient has had previous prosthetic hip replacement device (any type, including surface replacement arthroplasty, endoprosthesis, etc.) in the joint to be operated - The patient has a neurologic condition in the ipsolateral or contralateral limb which affects lower limb function. - The patient has a diagnosed systemic disease that could affect his/her safety or the study outcome. - The patient is known to be pregnant. - The patient is unwilling or unable to give informed consent, or to comply with the follow-up program. - The patient has received an investigational drug or device within the previous 6 months. - The patient has undergone a total hip replacement, endoprosthesis, or surface arthroplasty of the contralateral (opposite side) hip within the past 6 months regardless of whether the previous hip was enrolled in this clinical study. - The patient has an active or latent infection in or about the affected hip joint or an infection distant from the hip joint that may spread to the hip hematogenously. - The patient has had previous girdlestone procedure (resection arthroplasty) or surgical fusion of the hip to be operated. - The patient has insufficient bone stock to fix the component. Insufficient bone stock exists in the presence of metabolic bone disease (i.e. osteoporosis), cancer, and radiation. Note: Dual Energy X-ray Absorptiometry (DEXA) may be used to assess the presence of adequate bone stock. - The patient has known local bone tumors and/or cysts in the operative hip. - The patient has a known sensitivity or allergic reaction to one or more of the implanted materials. - The patient is Grade III obese with a Body Mass Index (BMI) > 35. - The patient has osteoradionecrosis in the affected hip joint |
Country | Name | City | State |
---|---|---|---|
Finland | HYKS-instituutti Oy | Helsinki | |
Italy | Dipartimento di Ricerca Traslazionale e delle Nuove Tecnologie in Medicina e Chirurgia, Università di Pisa | Pisa | |
Italy | Policlinico Tor Vergata | Rome | |
United Kingdom | Glasgow Royal Infirmary | Glasgow | |
United Kingdom | Nuffield Department of Orthopaedics, University of Oxford | Oxford | |
United Kingdom | Southampton General Hospital | Southampton |
Lead Sponsor | Collaborator |
---|---|
Zimmer Biomet |
Finland, Italy, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety will be evaluated by adverse events reporting. | Safety will be evaluated by monitoring the frequency and incidence of adverse events (AE), serious adverse events (SAE), adverse device effects (ADE) and serious adverse device effects (SADE) | 10 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04657926 -
A Trial of APPA in the Treatment of Knee Osteoarthritis
|
Phase 2 | |
Completed |
NCT02536833 -
A Study Evaluating the Safety, Tolerability, and Efficacy of SM04690 Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects
|
Phase 2 | |
Completed |
NCT03014037 -
Comparing Mesenchymal Stem Cell Counts in Unilateral vs. Bilateral Posterior Superior Iliac Spine Bone Marrow Aspiration
|
N/A | |
Recruiting |
NCT05937542 -
A Qualitative Investigation of CLEAT Participants
|
||
Completed |
NCT03644615 -
A Mindfulness Program (MBSR) in the Management of Symptomatic Hip and Knee Osteoarthritis
|
N/A | |
Recruiting |
NCT06061367 -
Muscles Strength and Gait Parameteres After TKA
|
||
Withdrawn |
NCT04976972 -
A Comparison of Patients Receiving a Total Knee Replacement With Robotic Assistance or With Conventional Instrumentation
|
N/A | |
Completed |
NCT05496205 -
A SAD Study to Evaluate the Safety, Tolerability and PK/PD of iN1011-N17 in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT03850665 -
Comparison of Functional Outcome in Patients After Hip Arthroplasty Depending on Surgical Approach
|
N/A | |
Completed |
NCT02826902 -
Effect of Anesthesia on Quality of Recovery in Patients Undergoing Correctional Tibial Osteotomy - A Randomized Controlled Trial
|
N/A | |
Completed |
NCT04402502 -
Dynamic 4DCT to Examine Wrist Carpal Mechanics
|
N/A | |
Completed |
NCT02923700 -
Leukocyte-rich PRP vs Leukocyte-poor PRP for the Treatment of Knee Cartilage Degeneration: a Randomized Controlled Trial
|
Phase 4 | |
Completed |
NCT04564053 -
Study of Safety, Tolerability and Pharmacokinetics of LNA043 in Japanese Osteoarthritis Participants
|
Phase 1 | |
Completed |
NCT05070871 -
A Clinical Trial Investigating the Effect of Salmon Bone Meal on Osteoarthritis Among Men and Women
|
N/A | |
Not yet recruiting |
NCT05036174 -
Diphenhydramine Ointment for Knee Osteoarthritis
|
N/A | |
Recruiting |
NCT02666443 -
Low Dose Dexamethasone in Supraclavicular Blocks
|
N/A | |
Recruiting |
NCT02912429 -
Onlay vs. Inlay Patellofemoral Arthroplasty
|
N/A | |
Active, not recruiting |
NCT02723929 -
Effects of tDCS and tUS on Pain Perception in OA of the Knee
|
||
Terminated |
NCT02820766 -
Journey II BCS CMS Total Knee System Compared to Other PS Total Knee Systems in PT Setting
|
N/A | |
Withdrawn |
NCT02921594 -
Kinematic Comparison of Vanguard XP and Vanguard CR Total Knee Arthroplasties
|
N/A |