Pelvic Alignment Level (PAL) Instrument Evaluation

NCT01312428 | Terminated Results

• 1 other identifier: 64
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Arthroplasty, Replacement, Hip

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

Pelvic Alignment Level (PAL)

OTHER

Pelvic Alignment Level Instrument Used

Device: Pelvic Alignment Level (PAL) Instrument

No Pelvic Alignment Level (PAL)

OTHER

No Pelvic Alignment Level Instrument Used

Device: No Pelvic Alignment Level (PAL) Instrument

Interventions

Pelvic Alignment Level (PAL) Instrument DEVICE

Pelvic Alignment Level Instrument Used

Pelvic Alignment Level (PAL)

No Pelvic Alignment Level (PAL) Instrument DEVICE

No Pelvic Alignment Level Instrument Used

No Pelvic Alignment Level (PAL)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stryker Orthopaedics: lead

Study Sites (1)

Healthcare Center for Advanced Medicine

Louisville, Kentucky, 40202, United States

Location

Results Point of Contact

• Title: Director of Clinical Research
• Organization: Stryker Orthopedics

ellen.axelson@stryker.com

201-831-5401

Study Officials

• Arthur L. Malkani, MD

  Healthcare Center for Advanced Medicine

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2011
• First Posted: March 10, 2011
• Study Start: February 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: November 17, 2017
• Results First Posted: August 28, 2014

Record last verified: 2015-02

Locations

US (1)