Ultra-Short Anatomic and Conventional Cementless Stems Cementless Stems in Patients Younger Than Fifty-Five Years Old
Comparison of the Outcomes of Ultra-Short Anatomic and Conventional Cementless Stems in Patients Younger Than Fifty-Five Years Old
1 other identifier
interventional
111
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jun 2001
Longer than P75 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 12, 2015
CompletedFirst Posted
Study publicly available on registry
January 14, 2015
CompletedJanuary 14, 2015
January 1, 2015
12.6 years
January 12, 2015
January 13, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Thigh pain
thigh pain,in visual analog scale 0 to 10.
10 year after the operation
Secondary Outcomes (1)
Harris hip score
10 year after the operation
Study Arms (2)
Conventional stem
EXPERIMENTALtotal hip replacement operated with conventional stem (Profile; DePuy, Leeds, United Kingdom)
Ultra-Short stem
ACTIVE COMPARATORtotal hip replacement operated with ultra-short stem (Proxima; DePuy, Leeds, United Kingdom)
Interventions
1. Simultaneous bilateral sequential total hip arthroplasties under the same anesthetic. 2. 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. 3. 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.
Eligibility Criteria
You may qualify if:
- End stage hip arthritis
You may not qualify if:
- Age above 50 years old
- Inflammatory arthritis
- Coexisting foot or ankle disorder limiting walking
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Young-Hoo Kim, M.D.
Professor
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 12, 2015
First Posted
January 14, 2015
Study Start
June 1, 2001
Primary Completion
January 1, 2014
Study Completion
March 1, 2014
Last Updated
January 14, 2015
Record last verified: 2015-01