NCT02656771

Brief Summary

The purpose of this study is to measure quantitatively the implant stability and implant related remodeling of the periprosthetic femoral bone of the new uncemented Echo® Bi-Metric® Full proximal Profile total hip arthroplasty (THA) stem, and compare it to the classical uncemented Bi-Metric® Porous Primary THA stem by measuring migration of the stem assessed by model-based radiosteriometric analysis (MB-RSA) and measuring the periprosthetic adaptive bone remodeling assessed by dual-energy x-ray absorptiometry (DXA).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

January 1, 2016

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

January 13, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 15, 2016

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

February 25, 2020

Status Verified

February 1, 2020

Enrollment Period

3.5 years

First QC Date

January 13, 2016

Last Update Submit

February 21, 2020

Conditions

Osteoarthritis, Hip

Keywords

THAHiparthroplasties

Outcome Measures

Primary Outcomes (1)

  • Migration of the stem

    The differences between the two stem designs are evaluated by measurements of migration of the stem assesed by Radiosteriometric analysis (RSA)

    2 years

Secondary Outcomes (2)

  • Adaptive bone remodeling

    2 years

  • Hip function

    2 years

Study Arms (2)

Echo Bi-Metric THA stem

ACTIVE COMPARATOR

Uncemented titanium alloy press-fit stem with a proximal plasma spray porous titanium coating designed for bone ingrowth and the distal part of the stem has a roughened titanium surface for bone on-growth. It is a relatively new implant that is now in routine clinical use. The stem uses many of the features of the known and used Integral® and Bi-Metric® hip stems while integrating new design features to further enhance clinical performance such as a reduced neck geometry to allow for increased ROM and decreased risk of neck impingement, a polished neck designed to reduce debris should impingement occur and a polished bullet-shape distal tip to reduce distal stresses.

Device: Echo Bi-Metric

Bi-Metric Porous Primary THA stem

NO INTERVENTION

Uncemented titanium alloy press-fit stem with a proximal plasma spray porous titanium coating designed for bone ingrowth and the distal part of the stem has a roughened titanium surface for bone on-growth. It was introduced in 1984 and have shown good clinical results and excellent stem survival in register studies

Interventions

Echo Bi-MetricDEVICE

The insertion of the Echo® Bi-Metric® THA stem

Echo Bi-Metric THA stem

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients bound to undergo total hip arthroplasty at the Department of Orthopedic - Surgery, Gentofte Hospital, Denmark.
  • Patients who have consented in writing to participate after having understood what it entails.
  • Patients diagnosed with primary osteoarthritis of one or both hips.

You may not qualify if:

  • Infection including osteomyelitis and sepsis.
  • Diseases affecting the bone metabolism (osteoporosis, Pagets disease, hyperparathyreoidism etc.).
  • Uncooperative patient or patients with neurological disorders who are considered incapable of following directions.
  • Patients with alcohol or drug abuse, estimated by the investigators.
  • Patients considered unable to understand the information in patients-papers, or who do not want to participate in the study.
  • Patients who do not speak nor understand Danish.
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gentofte Hospital

Hellerup, 2900, Denmark

Location

Related Publications (9)

  • Haugan K, Husby OS, Klaksvik J, Foss OA. The migration pattern of the Charnley femoral stem: a five-year follow-up RSA study in a well-functioning patient group. J Orthop Traumatol. 2012 Sep;13(3):137-43. doi: 10.1007/s10195-012-0187-x. Epub 2012 May 11.

    PMID: 22576838BACKGROUND

  • Nieuwenhuijse MJ, Valstar ER, Kaptein BL, Nelissen RG. Good diagnostic performance of early migration as a predictor of late aseptic loosening of acetabular cups: results from ten years of follow-up with Roentgen stereophotogrammetric analysis (RSA). J Bone Joint Surg Am. 2012 May 16;94(10):874-80. doi: 10.2106/JBJS.K.00305.

    PMID: 22617914BACKGROUND

  • O'Neill SC, Queally JM, Devitt BM, Doran PP, O'Byrne JM. The role of osteoblasts in peri-prosthetic osteolysis. Bone Joint J. 2013 Aug;95-B(8):1022-6. doi: 10.1302/0301-620X.95B8.31229.

    PMID: 23908414BACKGROUND

  • Jiang Y, Jia T, Wooley PH, Yang SY. Current research in the pathogenesis of aseptic implant loosening associated with particulate wear debris. Acta Orthop Belg. 2013 Feb;79(1):1-9.

    PMID: 23547507BACKGROUND

  • Nelissen RG, Pijls BG, Karrholm J, Malchau H, Nieuwenhuijse MJ, Valstar ER. RSA and registries: the quest for phased introduction of new implants. J Bone Joint Surg Am. 2011 Dec 21;93 Suppl 3:62-5. doi: 10.2106/JBJS.K.00907.

    PMID: 22262426BACKGROUND

  • Selvik G. Roentgen stereophotogrammetry. A method for the study of the kinematics of the skeletal system. Acta Orthop Scand Suppl. 1989;232:1-51.

    PMID: 2686344BACKGROUND

  • Ryd L. Micromotion in knee arthroplasty. A roentgen stereophotogrammetric analysis of tibial component fixation. Acta Orthop Scand Suppl. 1986;220:1-80.

    PMID: 3461667BACKGROUND

  • Snorrason F, Karrholm J. Primary migration of fully-threaded acetabular prostheses. A roentgen stereophotogrammetric analysis. J Bone Joint Surg Br. 1990 Jul;72(4):647-52. doi: 10.1302/0301-620X.72B4.2199453.

    PMID: 2199453BACKGROUND

  • Stiehl JB. Early cup instability with RSA predicts long-term aseptic loosening: commentary on an article by Marc J. Nieuwenhuijse, BSc, MD, et al.: "Good diagnostic performance of early migration as a predictor of late aseptic loosening of acetabular cups. Results from ten years of follow-up with Roentgen stereophotogrammetric analysis (RSA)". J Bone Joint Surg Am. 2012 May 16;94(10):e70. doi: 10.2106/JBJS.L.00080. No abstract available.

    PMID: 22617936BACKGROUND

Related Links

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Michael M Petersen, Professor

    Rigshospitalet, Denmark

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 13, 2016

First Posted

January 15, 2016

Study Start

January 1, 2016

Primary Completion

July 1, 2019

Study Completion

December 1, 2022

Last Updated

February 25, 2020

Record last verified: 2020-02

Locations

DK(1)