NCT01921309

Brief Summary

To demonstrate the safety and effectiveness of the Trinity™ BIOLOX delta™ Ceramic-on-Ceramic Total Hip System in comparison to the Trinity™ Acetabular Hip System,which is FDA cleared for use in the U.S. The comparison will be based upon clinical success at the Month 24 endpoint.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
342

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2012

Longer than P75 for not_applicable

Geographic Reach
2 countries

10 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 13, 2013

Completed
8.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

March 11, 2021

Status Verified

July 1, 2020

Enrollment Period

8.8 years

First QC Date

June 10, 2013

Last Update Submit

March 10, 2021

Conditions

OsteoarthritisAvascular NecrosisRheumatoid ArthritisCDH

Keywords

osteoarthritisavascular necrosisrheumatoid arthritiscorrection of functional deformitydysplasia of the hip

Outcome Measures

Primary Outcomes (1)

  • Composite Clinical Success

    * HHS ≥ 80 at Month 24 (good/excellent) * No serious, definitely device related complications with onset on or prior to Month 24 * No radiographic failure at Month 24 * No removal, replacement, or modification of any component on or prior to Month 24.

    24 months post-operative

Secondary Outcomes (5)

  • HHS

    24 months post-operative

  • HOOS score

    24 months

  • Subjective pain

    24 months

  • survival

    24 months

  • adverse events

    24 months

Study Arms (2)

Trinity CoC Total Hip System

EXPERIMENTAL

total hip replacement with a ceramic femoral head and ceramic acetabular cup liner

Device: Trinity CoC Total Hip System

Trinity Ceramic-on-Poly THR

ACTIVE COMPARATOR

total hip replacement with a ceramic femoral head and polyethylene acetabular cup liner

Device: Trinity Ceramic-on-Poly THR

Interventions

Trinity CoC Total Hip SystemDEVICE

total hip replacement with a ceramic femoral head which moves on a ceramic acetabular cup liner

Trinity CoC Total Hip System
Trinity Ceramic-on-Poly THRDEVICE

total hip replacement with a ceramic femoral head which moves on a highly cross-linked ultra high molecular weight polyethylene acetabular cup liner

Trinity Ceramic-on-Poly THR

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • preoperative Harris Hip Score of ≤ 70.
  • preoperative Harris Hip Total Pain score of at least moderate.
  • diagnosed with non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, rheumatoid arthritis, correction of functional deformity, developmental hip dysplasia (DDH) and congenital hip dysplasia (CDH).
  • pain rating of none or slight and are at least 12 months post-operative in the contralateral hip, if applicable.
  • have sufficient femoral and acetabular bone stock as determined by a clinician, and are suitable to receive implants as confirmed by x-rays.

You may not qualify if:

  • have a nutritional problem (protein, calorie, or vitamin/mineral deficiency) that may impair wound healing mechanisms as determined by the clinician /investigator.
  • have a neurological disorders which may interfere or adversely affect gait, balance, or weight bearing (e.g. muscular dystrophy, multiple sclerosis).
  • diagnosed with metabolic disorders (e.g. osteomalacia), which may impair bone metabolism.
  • diagnosed systemic disease that would affect their welfare or the overall outcome of study (i.e. Paget's disease, renal osteodystrophy)
  • immunologically suppressed.
  • receiving systemic steroid therapy, excluding inhalers, within 3 months prior to surgery.
  • diagnosed Charcot's disease, metastatic or neoplastic disease.
  • evidence of active infections that may spread to other areas of the body (e.g. osteomyelitis, pyogenic infection of the hip joint, overt infection, untreated urinary tract infection, etc.).
  • presence of a previous prosthetic hip replacement device (any type, including surface replacement arthroplasty, endoprosthesis, etc.) in the hip joint to be operated.
  • previous Girdlestone procedure (resection arthroplasty) or surgical fusion of the hip to be operated.
  • diagnosed with systemic lupus erythematosus, pigmented villonodular synovitis, juvenile rheumatoid arthritis or other diagnoses with autoimmune etiology.
  • diagnosed with osteoporosis or as evidenced on a DEXA scan for males over 75 or females over 65 years of age (within the last 12 months).
  • require structural bone grafts in order to support the prosthetic component(s) or to shape the bone to receive the implant(s).
  • have acute femoral neck fracture or hip fractures.
  • have an above the knee amputation of the contralateral and/or ipsilateral leg.
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Arkansas Specialty Orthopaedics

Little Rock, Arkansas, 72205, United States

Location

Denver Hip and Knee, Inc.

Parker, Colorado, 80134, United States

Location

Connecticut Joint Replacement Institute (CJRI)

Hartford, Connecticut, 06105, United States

Location

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224, United States

Location

Florida Orthopaedic Institute

Tampa, Florida, 33609, United States

Location

FMC Orthopedic Division

Tampa, Florida, 33613, United States

Location

Resurgens Orthopaedics

Austell, Georgia, 30106, United States

Location

OrthoCarolina Hip & Knee Center

Charlotte, North Carolina, 28207, United States

Location

Memorial Bone & Joint

Houston, Texas, 77043, United States

Location

Elective Orthopaedic Centre

Epsom, Surrey, KT18 7EG, United Kingdom

Location

MeSH Terms

Conditions

OsteoarthritisOsteonecrosisArthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBone DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and SymptomsConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Kathy Trier, Ph.D.

    Corin

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2013

First Posted

August 13, 2013

Study Start

December 1, 2012

Primary Completion

September 1, 2021

Study Completion

December 1, 2021

Last Updated

March 11, 2021

Record last verified: 2020-07

Locations

GB(1)US(9)