NCT04039984

Brief Summary

This is a prospective study to compare migration of the Microport Prime acetabular cup to a well-established acetabular cup design after total hip replacement. We will enroll 30 patients with the Prime cup and compare migration, function, pain and quality of life to a historical cohort of patients whom had a different cup used during surgery.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2019

Typical duration for not_applicable

Status
withdrawn

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

First Submitted

Initial submission to the registry

July 29, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 31, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

August 1, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

March 15, 2023

Status Verified

March 1, 2023

Enrollment Period

3 years

First QC Date

July 29, 2019

Last Update Submit

March 12, 2023

Conditions

Osteoarthritis, Hip

Keywords

radiostereometric analysisimplant migrationtotal hip replacementarthroplasty

Outcome Measures

Primary Outcomes (1)

  • Implant Migration

    Migration will include translations, rotations and maximum total point motion measured between the 3D CAD models of the cup and the bone bead segment using model-based RSA software

    2 years

Secondary Outcomes (3)

  • Short Form 12

    2 years

  • Western Ontario and McMaster Universities Osteoarthritis Index

    2 years

  • Harris Hip Score

    2 years

Study Arms (1)

Prime Cup

EXPERIMENTAL

The study group will receive a Prime cementless acetabular cup (manufactured by Microport located in Arlington, Tennessee). All patients will also receive a cementless Profemur femoral stem with a 32 mm CoCr femoral head, articulating on a highly crosslinked acetabular liner.

Device: Prime Cup

Interventions

Prime CupDEVICE

Patients in this group will have the Prime cementless acetabular cup used during surgery.

Prime Cup

Eligibility Criteria

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

You may qualify if:

  • hip osteoarthritis
  • scheduled for primary total hip arthroplasty
  • ability to provide informed consent
  • over the age of 18 years

You may not qualify if:

  • prior arthroplasty on the indicated joint
  • individuals who do not speak or understand English
  • individuals with neuromuscular disorders or cognitive impairments
  • individuals ho live \>100km from our centre and/or are unlikely to return for multiple follow-up appointments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Valstar ER, Gill R, Ryd L, Flivik G, Borlin N, Karrholm J. Guidelines for standardization of radiostereometry (RSA) of implants. Acta Orthop. 2005 Aug;76(4):563-72. doi: 10.1080/17453670510041574.

    PMID: 16195075BACKGROUND

  • Pijls BG, Nieuwenhuijse MJ, Fiocco M, Plevier JW, Middeldorp S, Nelissen RG, Valstar ER. Early proximal migration of cups is associated with late revision in THA: a systematic review and meta-analysis of 26 RSA studies and 49 survivalstudies. Acta Orthop. 2012 Dec;83(6):583-91. doi: 10.3109/17453674.2012.745353. Epub 2012 Nov 5.

    PMID: 23126575BACKGROUND

  • Malchau H, Bragdon CR, Muratoglu OK. The stepwise introduction of innovation into orthopedic surgery: the next level of dilemmas. J Arthroplasty. 2011 Sep;26(6):825-31. doi: 10.1016/j.arth.2010.08.007. Epub 2010 Oct 2.

    PMID: 20888183BACKGROUND

  • Naudie DD, Somerville L, Korczak A, Yuan X, McCalden RW, Holdsworth D, Bourne RB. A randomized trial comparing acetabular component fixation of two porous ingrowth surfaces using RSA. J Arthroplasty. 2013 Sep;28(8 Suppl):48-52. doi: 10.1016/j.arth.2013.06.041. Epub 2013 Aug 13.

    PMID: 23953963BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Douglas Naudie, MD

    London Health Sciences Centre

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: This study design will be a prospective cohort with a retrospective control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 29, 2019

First Posted

July 31, 2019

Study Start

August 1, 2019

Primary Completion

August 1, 2022

Study Completion

August 1, 2022

Last Updated

March 15, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

There is currently no plan to share individual participant data.