Prospective Randomised Study of a New an Uncemented Stem. | NCT04599582

Studies
Prospective Randomised Study of a New an Uncemented Stem.

NCT04599582

Sponsor

Sahlgrenska University Hospital

Status

Completed

Last Update Posted

Oct 22, 2020Actual

Enrollment

80Actual

Phase

Not Applicable

Conditions

Hip Osteoarthritis

Interventions

Hip Arthroplasty

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2016Actual

Primary Completion Date

May 31, 2019Actual

Completion Date

May 31, 2019Actual

First Submitted Date

Oct 13, 2020

First Submission Date that Met QC Criteria

Oct 19, 2020

First Posted Date

Oct 22, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 19, 2020

Last Update Posted Date

Oct 22, 2020Actual

Name	Class
Link America, Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SP-CL	Active Comparator		Device: Hip Arthroplasty
Corail	Active Comparator		Device: Hip Arthroplasty

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hip Arthroplasty	Device	Patients are operated with hip replacement.	Corail SP-CL

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Oxford hip score	Patient reported outcome measure	two years

Secondary Outcomes

Measure	Description	Time Frame
RSA-examination	Migration of stem	two years
Conventional X-rays	Detection of radiolucent lines	two years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Primary osteoartritis Secondary osteoartritis

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015207	Osteoarthritis, Hip

Ancestor Terms

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019644	Arthroplasty, Replacement, Hip

Ancestor Terms

ID	Term
D019643	Arthroplasty, Replacement
D001178	Arthroplasty
D019637	Orthopedic Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided