Signature Acetabular Posterior/Lateral Data Collection

NCT02220478 | Terminated Results

• 1 other identifier: ORTHO.CR.GH24
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Noninflammatory Degenerative Joint Disease; Avascular Necrosis; Rheumatoid Arthritis

Keywords

hip; Signature

Outcome Measures

Primary Outcomes (1)

• Operative Room Time

  Average operative time

  Surgery

Study Arms (2)

Signature Cutting Guides

ACTIVE COMPARATOR

Patients indicated for a Posterior Lateral THA utilizing non implantable Signature Cutting Guides during surgery.

Device: Posterior Lateral Approach Total Hip Arthroplasty

Conventional Instrumentation

ACTIVE COMPARATOR

Patients indicated for a Posterior Lateral THA utilizing non implantable Conventional Instrumentation during surgery.

Device: Posterior Lateral Approach Total Hip Arthroplasty

Interventions

Posterior Lateral Approach Total Hip Arthroplasty DEVICE

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.

Conventional Instrumentation; Signature Cutting Guides

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Subjects requiring primary total hip arthroplasty
• 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.

You may not qualify if:

• 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
• Surgical approach other than posterior lateral.
• Simultaneous bilateral procedures

Sponsors & Collaborators

• Zimmer Biomet: lead

MeSH Terms

Conditions

Osteonecrosis; Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arthritis; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed

Results Point of Contact

• Title: Hillary Overholser
• Organization: Zimmer Biomet

hillary.overholser@zimmerbiomet.com

574-933-4180

Study Officials

• Russell Schenck, Ph.D.

  Zimmer Biomet

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: August 18, 2014
• First Posted: August 20, 2014
• Study Start: November 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: October 25, 2022
• Results First Posted: October 25, 2022

Record last verified: 2022-09