Pelvic Alignment Level (PAL) Instrument Evaluation

Arthroplasty, Replacement, Hip Clinical Trial

— PAL  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01312428
• Other study ID #: 64
• Status: Terminated
• Phase: N/A
• First received: March 8, 2011
• Last updated: October 16, 2017
• Start date: February 2011
• Est. completion date: April 2012

Study information

• Verified date: February 2015
• Source: Stryker Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Hip

Intervention

Device:
• Pelvic Alignment Level (PAL) Instrument
Pelvic Alignment Level Instrument Used
• No Pelvic Alignment Level (PAL) Instrument
No Pelvic Alignment Level Instrument Used

Locations

Country	Name	City	State
United States	Healthcare Center for Advanced Medicine	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Stryker Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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