Overview

This trial is active, not recruiting.

Conditions noninflammatory degenerative joint disease, avascular necrosis, rheumatoid arthritis
Treatment posterior lateral approach total hip arthroplasty
Sponsor Biomet, Inc.
Start date November 2014
End date September 2016
Trial size 150 participants
Trial identifier NCT02220478, ORTHO.CR.GH24

Summary

The primary purpose of this pilot study is to evaluate the accuracy of cup placement between two instrumentation technologies: Cutting Guide and Conventional Instrumentation.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Patients indicated for a Posterior Lateral THA utilizing non implantable Signature Cutting Guides during surgery.
posterior lateral approach total hip arthroplasty
All patients enrolled in the study are indicated for a total hip replacement, and will receive this replacement from the surgeon via a Posterior Lateral surgical approach.
(Active Comparator)
Patients indicated for a Posterior Lateral THA utilizing non implantable Conventional Instrumentation during surgery.
posterior lateral approach total hip arthroplasty
All patients enrolled in the study are indicated for a total hip replacement, and will receive this replacement from the surgeon via a Posterior Lateral surgical approach.

Primary Outcomes

Measure
Radiographic evaluations to compare planned cup position to final cup position
time frame: 0-6 Weeks

Secondary Outcomes

Measure
Serious Adverse Events
time frame: Operative - 6 months post operative
Operative Room Time
time frame: Operative

Eligibility Criteria

Male or female participants from 20 years up to 75 years old.

Inclusion Criteria: - Subjects with one of the following indication: - Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis. - Rheumatoid arthritis. - Correction of functional deformity. - Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. Additional inclusion criteria include: - Subjects requiring primary total hip arthroplasty - 20 to 75 years of age - Subjects with a diagnosis of osteoarthritis or traumatic arthritis - Subjects willing to return for follow-up evaluations. - Subjects who can read, understand study information and give written consent without representation of a legally authorized representative. - Bilateral patients are included if staged. - Only Posterior Lateral Approach can be used for inclusion in this study Exclusion Criteria: - Exclusion criteria should be in accordance with Contraindications for the Biomet primary acetabular cup. Absolute contraindications include: infection, sepsis, osteomyelitis, and failure of a previous joint replacement. Additional contraindications include: - Subjects whose bony structure deviates substantially from the general norm sufficiently to require non-standard implants. Specific examples of these are total dislocation of the hip, severe coxa vera deformity, and severe forms of multiple epiphyseal dysplasia - Subjects unable to cooperate with and complete the study - Dementia and inability to understand and follow instructions - Neurological conditions affecting movement - Pregnancy Additional exclusion criteria include: - Surgical approach other than posterior lateral. - Simultaneous bilateral procedures

Additional Information

Official title A Prospective Controlled Study on Signature Anterior Posterior/Lateral Acetabular Cup Placement System in Total Hip Arthroplasty
Description Using a more advanced surgical technique may assist surgeons and patients in a variety of ways including identifying a specific-size for the prosthesis prior to surgery, increasing operating room efficiency, and reducing the number of traditional instruments needed. This may reduce cost associated with the instrument inventory and instrument sterilization. Operating time may also be reduced, potentially decreasing the patient's risk of infection. However, before these hypotheses can be tested, it is important to fully understand the efficacy and accuracy of Signature Custom Guides and their use in Total Hip Arthroplasty.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Biomet, Inc..