The Treatment of Knee Osteoarthritis With Balanced Buttress Absorbable Spacer
1 other identifier
interventional
150
1 country
2
Brief Summary
The investigators randomly divided the knee osteoarthritis patients met the inclusive criteria into two groups (study group and control group). Placement of balanced buttress absorbable spacer and total knee arthroplasty were conducted. The clinical outcome of two groups were compared in this study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jan 2017
2 active sites
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
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
February 18, 2017
CompletedFirst Posted
Study publicly available on registry
February 23, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2019
CompletedJune 23, 2017
February 1, 2017
1 year
February 18, 2017
June 22, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
functional outcome
walking distance the patients could bear
12 months
Secondary Outcomes (1)
complication
1 week
Study Arms (2)
balanced buttress absorbable spacer
EXPERIMENTALFor the patients of study group, a balanced buttress absorbable spacer was placed into tibia.
total knee arthroplasty
PLACEBO COMPARATORFor the patients of control group, total knee arthroplasty was conducted.
Interventions
For the patients of study group, a balanced buttress absorbable spacer was placed into the gap after the osteotomy of tibia and fibula to modify the lower limb line.
Total knee arthroplasty was conducted for the patients of control group
Eligibility Criteria
You may qualify if:
- years old
- Medial stenosis of the knee
- Varus deformity less than 20 degrees
You may not qualify if:
- Lateral stenosis of the knee
- Hepatic renal dysfunction
- Refuse to participate the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Hebei Medical University Third Hospital
Shijiazhuang, Hebei, 050051, China
Zhiyong Hou
Shijiazhuang, Hebei, 050051, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Yingze Zhang, M.D
Third Hospital of Hebei Medical University Department of Orthopaedic Surgery
- STUDY DIRECTOR
Zhiyong Hou, M.D
Third Hospital of Hebei Medical University Department of Orthopaedic Surgery
- PRINCIPAL INVESTIGATOR
Ruipeng Zhang, M.D
Third Hospital of Hebei Medical University Department of Orthopaedic Surgery
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 18, 2017
First Posted
February 23, 2017
Study Start
January 1, 2017
Primary Completion
January 1, 2018
Study Completion
January 1, 2019
Last Updated
June 23, 2017
Record last verified: 2017-02
Data Sharing
- IPD Sharing
- Will share