Continuum Ceramic on Ceramic Bearing Post Market Clinical Follow-Up Study

Status Active, not recruiting

Clinical Trial Summary

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.

Clinical Trial Description

The subject of this clinical investigation is the Continuum Ceramic Bearing THA System in primary total hip arthroplasty. This system consists of a cementless modular Trabecular Metal™ (TM) Continuum Acetabular Shell, a modular BIOLOX delta Taper liner, and a modular BIOLOX delta femoral head. The characteristics of this THA system may allow for reduction in wear and osteolysis as compared to other approved and marketed THA systems and thus increase the expected implant life. The study design will be a prospective, multicenter, non-comparative post-market study, involving orthopedic surgeons skilled in hip arthroplasty procedures. A total of 200 patients will be enrolled into the study distributed between 6 study centres. This number of clinical centers will permit assessment of consistency among a multitude of investigators. Follow-up visits will. be performed at 6 weeks, 6 months, 1,2, 3, 5; 7 and 10 years post-operatively. All potential study subjects will be required to participate in the Informed Consent Process. The safety and performance of the Implant System will be assessed as following: implant survivorship based on revision with removal of the study device; safety based on incidence and frequency of adverse events; and Performance will be determined by comparing the overall pain and functional performances, survivorship, subject quality-of-life and radiographic parameters of study subjects who received the Continuum Ceramic Bearing System. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03343171
Study type	Observational
Source	Zimmer Biomet
Contact
Status	Active, not recruiting
Phase
Start date	September 15, 2010
Completion date	September 2025

View Details

See also
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	`NCT02912429` - Onlay vs. Inlay Patellofemoral Arthroplasty	N/A
Recruiting	`NCT02666443` - Low Dose Dexamethasone in Supraclavicular Blocks	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

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.