Treatment Trials

12 Clinical Trials for Various Conditions

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RECRUITING
MDR - PMCF Study for Echo FX Stem With RingLoc Bipolar Acetabular Cup and Femoral Head
Description

The objective of this retrospective enrollment and prospective follow-up study is to confirm safety, performance, and clinical benefits of the Echo FX Stem with the RingLoc Bipolar Acetabular Cup and Femoral Head in hip hemiarthroplasty (implants and instrumentation) at a minimum of 10 years follow-up. All available retrospective data will be collected from each patient and a prospective aspect to the study will be necessary to reach the 10-year time point.

RECRUITING
Dual Mobility Acetabular Cups in Revision TJA
Description

The aim of this study is to the compare clinical outcomes of patients undergoing a revision total hip arthroplasty (THA) with the use of a dual mobility bearing versus a single bearing design with the use of a large femoral head (36mm or 40mm). We hypothesize the use of dual-mobility components in revision THA will be associated with a lower dislocation rate in the first year following surgery.

UNKNOWN
A Prospective RSA and Clinical Evaluation of the Trident II Acetabular Cup
Description

The objective of this study is to use radiostereometric analysis (RSA) and clinical outcome measures to evaluate early post-operative implant stability and the clinical performance of Stryker's Trident II Acetabular Cup.

TERMINATED
Survivorship, Radiographic, and Functional Outcomes of the Multihole Revision Acetabular Cup
Description

This study will evaluate patients receiving a multihole revision acetabular implant for total hip arthroplasty (THA) and will be followed for 10 years to collect data on survivorship of the implanted prosthesis.

COMPLETED
Correlation of Spinopelvic Parameters and Acetabular Cup Orientation
Description

In total hip arthroplasty, cup anteversion is an important factor in stability. Lewinnek's safe zone and functional anteversion are often used to assess appropriate orientation. However, these approaches do not consider the effect of the spinopelvic chain and lumbar mobility when in the seated position. This study will measure functional anteversion when standing and sitting with patient-specific computer models and define a quantitative relationship between the change in functional anteversion and spinopelvic parameters. This will challenge the historical paradigm of the safe zone and provide a tool to define anteversion based on a patient's mechanics and reduce risk of dislocation.

UNKNOWN
A Prospective Radiostereometric Analysis and Clinical Evaluation of the Zimmer® Continuum® Acetabular Cup With Vitamin E Stabilized Polyethylene
Description

The purpose of this study is to use Radiostereometric Analysis (RSA) and clinical outcome measures to evaluate early, post-operative implant stability, post-operative implant fixation, clinical performance, and in-vivo wear of the Zimmer® Continuum® Cup with vitamin E stabilized polyethylene.

COMPLETED
36 mm Ceramic-on-Ceramic Acetabular Cup Total Hip Replacement
Description

This study is a supplement to the 28 mm Ceramic-on-Ceramic study which was designed to evaluate artificial hips with a 28 mm ceramic head and liner to determine whether they perform as well as artificial hips with a 28 mm ceramic head and a polyethylene liner. This arm of the study is designed to compare a 36 mm ceramic head and sleeve with a subset of the control (28mm ceramic head and a polyethylene sleeve) from the original study (G030075) (NCT#00208507) with additional follow-up, to determine if they perform as well.

COMPLETED
Multi-Center Comparative Trial of the ASR™-XL Acetabular Cup System vs. the Pinnacle™ Metal- on- Metal Total Hip System
Description

The primary objective of this investigation is to evaluate the clinical and radiographic outcomes of the ASR™-XL Acetabular Cup System compared to the Pinnacle™ Acetabular Cup with a 28mm or 36mm ULTAMET™ metal insert.

COMPLETED
Clinical Study Evaluating an Acetabular Cup System After Total Hip Replacement
Description

This study is a clinical evaluation of survivorship of an acetabular cup system after total hip replacement using patient examinations and questionnaires.

COMPLETED
28 mm Ceramic-on-Ceramic Acetabular Cup Total Hip Replacement Study
Description

The study is designed to evaluate artificial hips with a 28 mm ceramic head and a ceramic liner to determine whether they perform as well as artificial hips with a 28 mm ceramic head and a polyethylene liner.

Conditions
COMPLETED
Acetabular Shell Positioning Using Patient Specific Instruments
Description

The proposed study is a double-blinded randomized controlled trial comparing patient specific instruments with solely standardized instruments and pre-operative planning used for the placement of the acetabular cup prosthesis used in total hip arthroplasty. The investigators will enroll 36 patients who have consented to total hip arthroplasty for treatment of hip pathology. This treatment is a standard of care. Patients will receive standard of care pre- and post-operative care and placement of standard of care implants all of which are commercially available and FDA approved for general use for the clinical indications used in these patients. All patients will receive a pre-operative CT scan for surgical planning and comparison with post-operative CT scan. The difference in intervention between the groups will be the creation and use of patient specific instruments from the pre-operative planning session. These instruments will be used for placement of an indexing peripheral guide wire to direct acetabular preparation and placement of the shell assisting standard surgical instruments. Print-offs from the pre-operative plan will also be used in the treatment group. The post-operative scan will be performed within two weeks of the surgery for both the treatment and control groups. The investigators will analyze the difference in acetabular shell placement (acetabular version and abduction angle) from the pre-operatively planned CT scan. These differences will be compared between the control and experimental groups.

COMPLETED
Durom(R) Hip Resurfacing System Multicenter Trial
Description

The purpose of the study is to gather clinical information on the safety and efficacy of the resurfacing devices in the young, active patient with advanced hip disease. Study enrollment has been temporarily suspended due to a change in the surgical technique.