MedDataX Logo

Pelvic Alignment Level (PAL) Instrument Evaluation

NCT ID: NCT01312428

Last Updated: 2017-11-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2012-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The study is conducted to evaluate the performance of the Pelvic Alignment Level (PAL) instrument in achieving desired acetabular position, desired leg length and offset after Total Hip Replacement (THR) reconstruction.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Total hip replacement (THR) has been a sucessful treatment for cases of degenerative joint diseases. However, post operative complications such as dislocations, osteolysis, component wear and migration are still a concern. It has been noted in the scientific literature that precise acetabular cup position helps reduce such post operative complications. The Pelvic Alignment Level (PAL) offers this solution by assessing pelvic motion and optimizing implant position without the need for intra-operative fluoroscopy or a large capital expenditure. The focus of this study is to evaluate the clinical outcomes (acetabular cup placement, femoral offset, and leg length) of using the PAL instrument to those without using PAL instrument during total hip replacement. This will be a prospective, post market, randomized multi-center clinical study.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Arthroplasty, Replacement, Hip

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pelvic Alignment Level (PAL)

Pelvic Alignment Level Instrument Used

Group Type OTHER

Pelvic Alignment Level (PAL) Instrument

Intervention Type DEVICE

Pelvic Alignment Level Instrument Used

No Pelvic Alignment Level (PAL)

No Pelvic Alignment Level Instrument Used

Group Type OTHER

No Pelvic Alignment Level (PAL) Instrument

Intervention Type DEVICE

No Pelvic Alignment Level Instrument Used

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pelvic Alignment Level (PAL) Instrument

Pelvic Alignment Level Instrument Used

Intervention Type DEVICE

No Pelvic Alignment Level (PAL) Instrument

No Pelvic Alignment Level Instrument Used

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patient has signed an IRB approved, evaluation specific Informed Patient Consent Form.
* Patient is a male or non-pregnant female age 18 years or older at time of enrollment.
* Patient clinically qualifies for total hip arthroplastic surgery, based on physical examination and medical history.
* Patient must have a diagnosis of: osteoarthritis, traumatic arthritis, avascular necrosis, slipped capital epiphysis, pelvic fracture, failed fracture fixation or rheumatoid arthritis.

Exclusion Criteria

* Patient's anatomy precludes a cup placement of 45° inclination and 20° anteversion.
* Patient has an active infection within the affected hip joint.
* Patient is a prisoner.
* Patient has plans to relocate to another geographic area before the completion of the evaluation.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Stryker Orthopaedics

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Arthur L. Malkani, MD

Role: STUDY_CHAIR

Healthcare Center for Advanced Medicine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Healthcare Center for Advanced Medicine

Louisville, Kentucky, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

64

Identifier Type: -

Identifier Source: org_study_id