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Modular Dual Mobility Total Hip Arthroplasty Compared with Fixed Bearing Total Hip Arthroplasty for Femoral Neck Fractures in the Healthy Elderly

Status Approved

First Submitted Date

2020/07/03
Registered Date

2021/03/25
Last Updated Date

2021/03/17

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0006028
Unique Protocol ID	PC20OADI0023
Public/Brief Title	Outcome of Modular Dual Mobility Total Hip Arthroplasty in Healthy Elderly
Scientific Title	Modular Dual Mobility Total Hip Arthroplasty Compared with Fixed Bearing Total Hip Arthroplasty for Femoral Neck Fractures in the Healthy Elderly
Acronym
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	PIRB-신20200507-039
Approval Date	2020-05-07
Institutional Review Board Name	Eunpyung St. Mary's Hospital Institutional Review Board
Institutional Review Board Address	405, Byulgwan, Eunpyung Saint Mary's Hospital, 1021, Tongil-ro, Eunpyeong-gu, Seoul, Republic of Korea
Institutional Review Board Telephone	02-2030-3715
Data Monitoring Committee

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Seung-Chan Kim
Title	Assistant professor
Telephone	+82-2-2030-4628
Affiliation	The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Address	Eunpyung Saint Mary's Hospital, 1021, Tongil-ro, Eunpyeong-gu, Seoul, Republic of Korea
Contact Person for Public Queries
Name	Seung-Chan Kim
Title	Assistant professor
Telephone	+82-2-2030-4628
Affiliation	The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Address	Eunpyung Saint Mary's Hospital, 1021, Tongil-ro, Eunpyeong-gu, Seoul, Republic of Korea
Contact Person for Updating Information
Name	Seung-Chan Kim
Title	Assistant professor
Telephone	+82-2-2030-4628
Affiliation	The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Address	Eunpyung Saint Mary's Hospital, 1021, Tongil-ro, Eunpyeong-gu, Seoul, Republic of Korea

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Multi-center Number of center : 2
Overall Recruitment Status	Recruiting
Date of First Enrollment	2021-03-02 Actual
Target Number of Participant	120
Primary Completion Date
Study Completion Date
Name of Study	The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2021-03-02 ,
Recruitment Status by Participating Study Site 2
Name of Study	The Catholic University of Korea, Seoul St. Mary's Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2021-03-02 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Organization Type	Medical Institute
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	Almost all femoral neck fractures require surgery, and bipolar hemiarthroplasties(BPHA) and total hip arthroplasties(THA) are occasionaly used. THAs are preferred in that it show better recovery and lesser inguinal pains than BPHAs, but have complications of dislocations which often leads to revisional surgeries. Over 65 years old population and in turn osteoporotic femoral neck fractures are anticipated to increase exponentially, and older aged patients have higher risk of disclocations, which are recently lowered with the introduction of dual mobility constructs. However, they have concerns of increased articular surface wear due to additional mobile surface compared with fixed bearing arthroplasties. Head-to-head studies have been conducted recently, but multicentered, randomized controll trials have not been yet introduced. Patients admitted via emergency rooms or outpatient departents will be random block (4 to 6 patients in a block) assigned in to two groups: (1) Fixed bearing total hip arthroplasty, and (2) Modular dual mobility total hip arthroplasty. Outcomes will be measured up to 2 years after surgery. Additionaly, duration of anesthesia, estimated blood loss, required transfusions will be compared and also pain measurements (VAS pain scale), clinical scores (Harris hip score, WOMAC score), patient satisfactory measurements, ambulation status (Koval stage) will be evaluated. Above mentioned radiological parameters and clinical evaluations are routinely checked assessment tools. Also operative techniques used in the study is internationally and traditionally used treatment of choice. Therefore unexpected or additionally dangerous complications are not to be worrisome in this study.

Study Summary Information

Lay Summary

Almost all femoral neck fractures require surgery, and bipolar hemiarthroplasties(BPHA) and total hip arthroplasties(THA) are occasionaly used. THAs are preferred in that it show better recovery and lesser inguinal pains than BPHAs, but have complications of dislocations which often leads to revisional surgeries. Over 65 years old population and in turn osteoporotic femoral neck fractures are anticipated to increase exponentially, and older aged patients have higher risk of disclocations, which are recently lowered with the introduction of dual mobility constructs. However, they have concerns of increased articular surface wear due to additional mobile surface compared with fixed bearing arthroplasties. Head-to-head studies have been conducted recently, but multicentered, randomized controll trials have not been yet introduced.
Patients admitted via emergency rooms or outpatient departents will be random block (4 to 6 patients in a block) assigned in to two groups: (1) Fixed bearing total hip arthroplasty, and (2) Modular dual mobility total hip arthroplasty. Outcomes will be measured up to 2 years after surgery.
Additionaly, duration of anesthesia, estimated blood loss, required transfusions will be compared and also pain measurements (VAS pain scale), clinical scores (Harris hip score, WOMAC score), patient satisfactory measurements, ambulation status (Koval stage) will be evaluated. Above mentioned radiological parameters and clinical evaluations are routinely checked assessment tools. Also operative techniques used in the study is internationally and traditionally used treatment of choice. Therefore unexpected or additionally dangerous complications are not to be worrisome in this study.

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Treatment
Phase	Not applicable
Intervention Model	Parallel
Blinding/Masking	Open
Allocation	RCT
Intervention Type	/Procedure/Surgery
Intervention Description	Patients admitted via emergency rooms or outpatient departents will be random block (4 to 6 patients in a block) assigned in to two groups: (1) Fixed bearing total hip arthroplasty, and (2) Modular dual mobility total hip arthroplasty. Outcomes will be measured up to 2 years after surgery.
Number of Arms	2
Arm 1	Arm Label Modular Dual Mobility Total Hip Arthroplasty
	Target Number of Participant 60
	Arm Type Experimental
	Arm Description Dual mobility total hip arthroplasties are performed by inserting dual mobility implants: liner & cup. The liner and cup are coupled inside the operative field before insertion to form the implant hip joint.
Arm 2	Arm Label Fixed Bearing Total hip Arthroplasty
	Target Number of Participant 60
	Arm Type Experimental
	Arm Description Traditionally applied fixed bearing total hip arthroplasty technique uses currently widely used fixed bearing liner and cups to form the implant hip joint.

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	(M00-M99)Diseases of the musculoskeletal system and connective tissue 'Femoral Neck Fractures' in healthy elderly
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 50Year~85Year
	Description Patients with femoral neck fractures from age of 50 to 85 years who require total hip arthroplasty Indepent ambulation before the fracture Agrees and willing to participate in ambulation rehabilitation
Exclusion Criteria	High fall risk patients (Parkinson's disesae, dementia, etc.) Previous hip surgery History of local infections, sepsis or severe infections to lower extremity Neurogenic sequelae due to previous cerebrovascular accident Unable to independently ambulate before the onset of fracture 85 years or older Patients who are unable to attend follow up schedules
Healthy Volunteers	Yes

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	/Safety/Efficacy
Outcome	Dislocation rate
Timepoint	6 weeks, 6 months, 1 year, and 2 years after the surgery
Primary Outcome(s) 2
Outcome	Revision surgery rate
Timepoint	6 weeks, 6 months, 1 year, and 2 years after the surgery
Secondary Outcome(s) 1
Outcome	Complication rates (PTE/DVT, pressure sore, surgical site infection, hematome)
Timepoint	6 weeks, 6 months, 1 year, and 2 years after the surgery
Secondary Outcome(s) 2
Outcome	Radiological outcomes
Timepoint	6 weeks, 6 months, 1 year, and 2 years after the surgery
Secondary Outcome(s) 3
Outcome	Readmission rate (30days/90days)
Timepoint	6 weeks, 6 months, 1 year, and 2 years after the surgery
Secondary Outcome(s) 4
Outcome	Mortality rate
Timepoint	6 weeks, 6 months, 1 year, and 2 years after the surgery
Secondary Outcome(s) 5
Outcome	Time of anesthesia
Timepoint	6 weeks, 6 months, 1 year, and 2 years after the surgery
Secondary Outcome(s) 6
Outcome	Estimated blood loss
Timepoint	6 weeks, 6 months, 1 year, and 2 years after the surgery
Secondary Outcome(s) 7
Outcome	Transfusion requirements
Timepoint	6 weeks, 6 months, 1 year, and 2 years after the surgery
Secondary Outcome(s) 8
Outcome	Clinical scores: VAS pain scale, Harris hip score, WOMAC score, EQ-5D index
Timepoint	6 weeks, 6 months, 1 year, and 2 years after the surgery
Secondary Outcome(s) 9
Outcome	Ambulation status (Koval stage)
Timepoint	6 weeks, 6 months, 1 year, and 2 years after the surgery

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

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