NCT04731077

Brief Summary

The main objectives of this study are to confirm the long-term safety, performance and clinical benefits the Avenir Complete femoral stem and its instrumentation when used in primary total, hemi, and revision hip arthroplasty.

Trial Health

82
On Track

Trial Health Score

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

Enrollment
275

participants targeted

Target at P75+ for not_applicable

Timeline
123mo left

Started Sep 2021

Longer than P75 for not_applicable

Geographic Reach
6 countries

9 active sites

Status
active not recruiting

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 Progress31%
Sep 2021Jun 2036

First Submitted

Initial submission to the registry

January 28, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 29, 2021

Completed
8 months until next milestone

Study Start

First participant enrolled

September 27, 2021

Completed
13.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2035

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2036

Last Updated

June 18, 2025

Status Verified

June 1, 2025

Enrollment Period

13.7 years

First QC Date

January 28, 2021

Last Update Submit

June 13, 2025

Conditions

Osteoarthritis, HipAvascular Necrosis of HipAvascular Necrosis of the Femoral HeadPost-traumatic; Arthrosis

Outcome Measures

Primary Outcomes (1)

  • Survival of the study device; whether or not it is still implanted in the subject

    Survival is classified as removal of the study device for any reason

    10 years

Secondary Outcomes (5)

  • Incidence of treatment-emergent Adverse Events (safety)

    10 years

  • Harris Hip Score

    3 years

  • Patient Quality of Life

    10 years

  • Radiographic analysis

    10 years

  • Oxford Hip Score

    10 years

Study Arms (1)

Avenir Complete Femoral Stem

OTHER

All enrolled subjects receive the study implant

Device: Avenir Complete Femoral Stem

Interventions

Avenir Complete Femoral StemDEVICE

All enrolled subjects will receive the Avenir Complete Femoral Stem

Avenir Complete Femoral Stem

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient is at least 20 years old or older and skeletally mature.
  • Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases;
  • Failed previous hip surgery including
  • Joint reconstruction (osteotomy)
  • Arthrodesis
  • Hemi-arthroplasty or total hip replacement (THR)
  • Acute traumatic fracture of the femoral head or neck;
  • Avascular necrosis of the femoral head.
  • Patients capable of understanding the surgeon's explanations and following his instructions, able and willing to participate in the follow-up program and who gave consent to take part in the study;

You may not qualify if:

  • Acute, chronic, local, or systemic infections;
  • Severe muscular, neural, or vascular diseases that endanger the limbs involved;
  • Patient is at least 20 years old or older and skeletally mature.
  • Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases;
  • Failed previous hip surgery including
  • Joint reconstruction (osteotomy)
  • Arthrodesis
  • Hemi-arthroplasty or total hip replacement (THR)
  • Acute traumatic fracture of the femoral head or neck;
  • Avascular necrosis of the femoral head.
  • Patients capable of understanding the surgeon's explanations and following his instructions, able and willing to participate in the follow-up program and who gave consent to take part in the study;
  • Acute, chronic, local, or systemic infections;
  • Severe muscular, neural, or vascular diseases that endanger the limbs involved;
  • Lack of bony structures proximal or distal to the joint, so that good anchorage of the implant is unlikely or impossible;
  • Total or partial absence of the muscular or ligamentous apparatus;
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Mississippi Sports Medicine and Orthopaedic Center PLLC

Jackson, Mississippi, 39202, United States

Location

Heartland Regional Medical Center d.b.a. Mosaic Life Care

Saint Joseph, Missouri, 64506, United States

Location

Orthopedic & Fracture Clinic, PC

Portland, Oregon, 97225, United States

Location

Copenhagen University Hospital, Hvidovre

Copenhagen, DK-2650, Denmark

Location

Nissan Tamagawa Hospital

Setagaya-Ku, Tokyo, 410-0302, Japan

Location

Okayama City Hospital

Okayama, 700-0962, Japan

Location

Ikazia Ziekenhuis

Rotterdam, South Holland, 3083 AN, Netherlands

Location

Sykehuset Innlandet HF

Tynset, 2500, Norway

Location

Sahlgrenska University Hospital - Molndal

Mölndal, 43180, Sweden

Location

MeSH Terms

Conditions

Osteoarthritis, HipFemur Head NecrosisOsteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesOsteonecrosisBone DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2021

First Posted

January 29, 2021

Study Start

September 27, 2021

Primary Completion (Estimated)

June 1, 2035

Study Completion (Estimated)

June 1, 2036

Last Updated

June 18, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)US(3)NL(1)NO(1)SE(1)JP(2)