Ultra-Short Anatomic and Conventional Cementless Stems Cementless Stems in Patients Younger Than Fifty-Five Years Old
Primary Purpose
Hip Replacement, Total, Osteonecrosis of Femoral Head, Coxarthrosis
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Total hip replacement
Sponsored by
About this trial
This is an interventional treatment trial for Hip Replacement, Total
Eligibility Criteria
Inclusion Criteria:
- End stage hip arthritis
Exclusion Criteria:
- Age above 50 years old
- Inflammatory arthritis
- Coexisting foot or ankle disorder limiting walking
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Conventional stem
Ultra-Short stem
Arm Description
total hip replacement operated with conventional stem (Profile; DePuy, Leeds, United Kingdom)
total hip replacement operated with ultra-short stem (Proxima; DePuy, Leeds, United Kingdom)
Outcomes
Primary Outcome Measures
Thigh pain
thigh pain,in visual analog scale 0 to 10.
Secondary Outcome Measures
Harris hip score
Full Information
NCT ID
NCT02338596
First Posted
January 12, 2015
Last Updated
January 13, 2015
Sponsor
Ewha Womans University
1. Study Identification
Unique Protocol Identification Number
NCT02338596
Brief Title
Ultra-Short Anatomic and Conventional Cementless Stems Cementless Stems in Patients Younger Than Fifty-Five Years Old
Official Title
Comparison of the Outcomes of Ultra-Short Anatomic and Conventional Cementless Stems in Patients Younger Than Fifty-Five Years Old
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
June 2001 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ewha Womans University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
As clinical and radiographic performance of an ultra-short anatomic cementless stem have been investigated only two randomized controlled studies, well-designed trials should aim for a thorough comparison of the outcomes of ultra-short and conventional cementless stems. The purpose of this study was to compare the outcomes of ultra-short and conventional stems in the same young patients who underwent simultaneous bilateral sequential total hip arthroplasties.
Detailed Description
Conventional cementless femoral stems are known to provide a high rate of satisfactory clinical outcomes at long-term follow-ups. However, they may have potential clinical consequences related to stress shielding, thigh pain, periprosthetic fractures, proximal/distal dimensional mismatch, an easier access pathway for wear debries and removal during revision. In an effort to reduce the risk of stress shielding, thigh pain, periprosthetic fracture, proximal/distal stem mismatch, and to facilitate removal of well fixed stem, a new ultra-short anatomic metaphyseal-fitting cementless femoral stem was developed. It was designed to provide closely mimicking the original functioning hip. The absence of the diaphyseal anchorage attempt proximal load transfer to reduce stress shielding, thigh pain and proximal distal/mismatch. Furthermore, it attempts to preservation of the femoral canal and femoral elasticity and ease of revision. The question thus arises whether it is possible to obtain strong and long-lasting fixation of the femoral component without diaphyseal anchoring.
As clinical and radiographic performances of this ultra-short stem have been investigated only in a few studies and at short-term follow-ups, it remains to be elucidated whether an ultra-short stem shows a low incidence of implant loosening, stem misalignment, intraoperative fractures and revision rate. The purpose of this randomized controlled study to compare: (1) the clinical results, including Harris hip score, thigh pain, Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index score, and patients' satisfaction; (2) radiographic results, including stress shielding, implant loosening, stem misalignment; and (3) intraoperative fractures and revision rates of cementless total hip arthroplasty using an ultra-short anatomic metaphyseal-fitting cementless femoral stem versus a conventional metaphyseal and diaphyseal fitting anatomi proximal porous-coated cementless stem in the same patients who underwent bilateral simultaneous sequential total hip arthroplasty under one anesthetic.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Replacement, Total, Osteonecrosis of Femoral Head, Coxarthrosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
111 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional stem
Arm Type
Experimental
Arm Description
total hip replacement operated with conventional stem (Profile; DePuy, Leeds, United Kingdom)
Arm Title
Ultra-Short stem
Arm Type
Active Comparator
Arm Description
total hip replacement operated with ultra-short stem (Proxima; DePuy, Leeds, United Kingdom)
Intervention Type
Procedure
Intervention Name(s)
Total hip replacement
Intervention Description
Simultaneous bilateral sequential total hip arthroplasties under the same anesthetic.
Randomization to treatment with an ultra-short or a convnetional cementless stem was accomplished with use of study numbers in sealed envelope, which were opened in the operating room before the skin incision was made.
The pore size was 250㎛. A 28-mm-diameter Biolox forte ceramic femoral head (CeramTec AG, Polchingen, Germany) ) was used in all hips. A cementless cup and a 28mm internal-diameter Biolox forte ceramic liner was used in all hips in both groups.
Primary Outcome Measure Information:
Title
Thigh pain
Description
thigh pain,in visual analog scale 0 to 10.
Time Frame
10 year after the operation
Secondary Outcome Measure Information:
Title
Harris hip score
Time Frame
10 year after the operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
End stage hip arthritis
Exclusion Criteria:
Age above 50 years old
Inflammatory arthritis
Coexisting foot or ankle disorder limiting walking
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young-Hoo Kim, M.D.
Organizational Affiliation
Professor
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Ultra-Short Anatomic and Conventional Cementless Stems Cementless Stems in Patients Younger Than Fifty-Five Years Old
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