Pelvic Alignment Level (PAL™) Instrument Evaluation

This study has been terminated.
Sponsor:
Information provided by:
Stryker Orthopaedics
ClinicalTrials.gov Identifier:
NCT01312428
First received: March 8, 2011
Last updated: October 7, 2011
Last verified: March 2011
  Purpose

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


Condition Intervention
Arthroplasty, Replacement, Hip
Procedure: Pelvic Alignment Level (PAL) Instrument
Procedure: Total Hip Replacement

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Clinical Evaluation of Acetabular Cup Placement in Total Hip Replacements Utilizing a Pelvic Alignment Level (PAL™) Instrument

Resource links provided by NLM:


Further study details as provided by Stryker Orthopaedics:

Primary Outcome Measures:
  • 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. [ Time Frame: 6 week follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 6 week follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: February 2011
Arms Assigned Interventions
PAL
The cases randomized into the PAL group will have total hip replacement surgery performed utilizing the PAL™ instrument.
Procedure: Pelvic Alignment Level (PAL) Instrument
Total hip replacement surgery will be performed utilizing the PAL Instrument.
No PAL
The cases randomized into the no PAL group will have total hip replacement surgery performed without the use of the PAL™ instrument. This group will serve as the control group.
Procedure: Total Hip Replacement
Total hip replacement surgery will be performed without utilizing the PAL Instrument.

Detailed Description:

Total hip replacement (THR) has been a sucessful treatment for cases of degenrative 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, multi-center clinical study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01312428

Locations
United States, Kentucky
Healthcare Center for Advanced Medicine
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
Stryker Orthopaedics
Investigators
Study Chair: Arthur L. Malkani, MD Healthcare Center for Advanced Medicine
  More Information

No publications provided

Responsible Party: Ellen Axelson/ Director, Clinical Research, Stryker Orthopaedics
ClinicalTrials.gov Identifier: NCT01312428     History of Changes
Other Study ID Numbers: 64
Study First Received: March 8, 2011
Last Updated: October 7, 2011
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on August 19, 2014