Pelvic Alignment Level (PAL) Instrument Evaluation

Stryker

Status: Terminated

Conditions: Arthroplasty, Replacement, Hip

Treatments: Device: Pelvic Alignment Level (PAL) Instrument; Device: No Pelvic Alignment Level (PAL) Instrument

Study type: Interventional

Funder types: Industry

Identifiers

NCT01312428

64

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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7 participants in 2 patient groups

Pelvic Alignment Level (PAL)

Other group

Description:

Pelvic Alignment Level Instrument Used

Treatment:

Device: Pelvic Alignment Level (PAL) Instrument

No Pelvic Alignment Level (PAL)

Other group

Description:

No Pelvic Alignment Level Instrument Used

Treatment:

Device: No Pelvic Alignment Level (PAL) Instrument