NCT04599582

Brief Summary

Patients will be randomised to either operation with a Corail stem or a SP-CL stem. The groups are examined with RSA, conventional x-rays, PROM-data and DXA. First evaluation will be done at two years.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable

Status
completed

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

April 1, 2016

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2019

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 13, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 22, 2020

Completed
Last Updated

October 22, 2020

Status Verified

October 1, 2020

Enrollment Period

3.2 years

First QC Date

October 13, 2020

Last Update Submit

October 19, 2020

Conditions

Hip Osteoarthritis

Keywords

hip arthroplastyJoint replacementUncemented stemAnatomical stem

Outcome Measures

Primary Outcomes (1)

  • Oxford hip score

    Patient reported outcome measure

    two years

Secondary Outcomes (4)

  • RSA-examination

    two years

  • Conventional X-rays

    two years

  • Harris hip score

    two years

  • DXA

    Two years

Study Arms (2)

SP-CL

ACTIVE COMPARATOR
Device: Hip Arthroplasty

Corail

ACTIVE COMPARATOR
Device: Hip Arthroplasty

Interventions

Hip ArthroplastyDEVICE

Patients are operated with hip replacement.

CorailSP-CL

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary osteoartritis Secondary osteoartritis

You may not qualify if:

  • Ongoing treatment with corticoid steroids, Active cancer disease, previously known osteoporosis or osteomalacia, inflammatory arthritis, unsuitable anatomy, difficulties to speak or understand the Swedish language.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis, Hip

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 13, 2020

First Posted

October 22, 2020

Study Start

April 1, 2016

Primary Completion

May 31, 2019

Study Completion

May 31, 2019

Last Updated

October 22, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share