Pelvic Alignment Level (PAL) Instrument Evaluation (PAL)

A Prospective Clinical Evaluation of Acetabular Cup Placement in Total Hip Replacements Utilizing a Pelvic Alignment Level (PAL) Instrument

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.

Study Overview

• Status: Terminated
• Conditions: Arthroplasty, Replacement, Hip
• Intervention / Treatment: Device: Pelvic Alignment Level (PAL) Instrument; Device: No Pelvic Alignment Level (PAL) Instrument

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Healthcare Center for Advanced Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Pelvic Alignment Level (PAL); Pelvic Alignment Level Instrument Used	Device: Pelvic Alignment Level (PAL) Instrument; Pelvic Alignment Level Instrument Used
Other: No Pelvic Alignment Level (PAL); No Pelvic Alignment Level Instrument Used	Device: No Pelvic Alignment Level (PAL) Instrument; No Pelvic Alignment Level Instrument Used

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To Evaluate the Surgical Accuracy in Placing Acetabular Components at a Target of 45° Inclination and 20° Anteversion While Using the PAL Compared to Surgeries Without Using the PAL Instrument.	6 week follow-up

Secondary Outcome Measures

Outcome Measure	Time Frame
To Evaluate the Surgical Success of Achieving Preoperative Targets for Leg Length and Femoral Offset, or be Able to Document Changes to Pre-operative Leg Length and Offset, Using the PAL Compared to Surgeries Without Using the PAL Instrument.	6 week follow-up

Collaborators and Investigators

• Sponsor: Stryker Orthopaedics
• Investigators: Study Chair: Arthur L. Malkani, MD, Healthcare Center for Advanced Medicine

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: March 8, 2011
• First Submitted That Met QC Criteria: March 8, 2011
• First Posted (Estimate): March 10, 2011

Study Record Updates

• Last Update Posted (Actual): November 17, 2017
• Last Update Submitted That Met QC Criteria: October 16, 2017
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: 64