Ignite Creation Date:
2024-05-06 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 1:52 PM
Study NCT ID:
NCT04685239
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-03-27
First Post:
2020-12-15
Brief Title:
Dual Mobility Cup Versus Unipolar Cup
Sponsor:
Northern Orthopaedic Division Denmark
Organization:
Northern Orthopaedic Division Denmark
Study Overview
Official Title:
Risk of Dislocation After Total Hip Replacement Dual Mobility Cup vs Unipolar Cup A Randomized Controlled Trial With Patients 65 Years Operated for Hip Osteoarthritis With Primary Total Hip Replacement THR
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The general purpose of this study is to examine whether the dual mobility cup Novae Serf reduces the number of hip dislocations after total hip replacement both early dislocation 1 year and late dislocation 1 year after primary THR compared with a conventional cup design Trabecular MetalTM Modular Acetabular System
Detailed Description:
Surgery with THR for arthritis and other hip disorders has long been one of the most successful orthopedic surgical treatments The majority of the patients gain pain relief and experience improved hip function In 2017 a total of 10691 THRs were implanted in Denmark annual report 2018
Hip dislocation is a known complication after THR It is a painful condition which may have far-reaching consequences for the patient who may experience both physical and mental discomfort Ultimately multiple hip dislocations may result in reoperation
In the literature the incidence of hip dislocation is reported at 2-6 and a more recent review reports a risk of 05-10
In Denmark recurrent hip dislocation is the cause of 21 of the reoperations per year according to The Danish Hip Arthroplasty Register According to the British National Joint Registry NJR and the Australian register AOANJRR hip dislocation is the cause of 155 and 21 respectively of the reoperations
The best method to avoid reoperation due to instability is to choose the correct implant for the individual patient and thereby spare the patient of having to endure a painful complication and yet another procedure There are multiple risk factors for instability after THR and increased use of dual mobility cups DMC is already documented
Hip dislocation is a known complication after THR It is a painful condition which may have far-reaching consequences for the patient who may experience both physical and mental discomfort Ultimately multiple hip dislocations may result in reoperation
In the literature the incidence of hip dislocation is reported at 2-6 and a more recent review reports a risk of 05-10
In Denmark recurrent hip dislocation is the cause of 21 of the reoperations per year according to The Danish Hip Arthroplasty Register According to the British National Joint Registry NJR and the Australian register AOANJRR hip dislocation is the cause of 155 and 21 respectively of the reoperations
The best method to avoid reoperation due to instability is to choose the correct implant for the individual patient and thereby spare the patient of having to endure a painful complication and yet another procedure There are multiple risk factors for instability after THR and increased use of dual mobility cups DMC is already documented
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None