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The Treatment of Knee Osteoarthritis With Balanced Buttress Absorbable Spacer

Primary Purpose

Osteoarthritis, Knee

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
balanced buttress absorbable spacer
total knee arthroplasty
Sponsored by
Hebei Medical University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 40-80 years old
  • Medial stenosis of the knee
  • Varus deformity less than 20 degrees

Exclusion Criteria:

  • Lateral stenosis of the knee
  • Hepatic renal dysfunction
  • Refuse to participate the study

Sites / Locations

  • Hebei Medical University Third HospitalRecruiting
  • Zhiyong HouRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

balanced buttress absorbable spacer

total knee arthroplasty

Arm Description

For the patients of study group, a balanced buttress absorbable spacer was placed into tibia.

For the patients of control group, total knee arthroplasty was conducted.

Outcomes

Primary Outcome Measures

functional outcome
walking distance the patients could bear

Secondary Outcome Measures

complication
vascular nerve bundle injury

Full Information

First Posted
February 18, 2017
Last Updated
June 22, 2017
Sponsor
Hebei Medical University Third Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03060382
Brief Title
The Treatment of Knee Osteoarthritis With Balanced Buttress Absorbable Spacer
Official Title
The Treatment of Knee Osteoarthritis With Balanced Buttress Absorbable Spacer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (Actual)
Primary Completion Date
January 2018 (Anticipated)
Study Completion Date
January 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hebei Medical University Third Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Knee osteoarthritis, caused by non-uniform settlement of medial and lateral tibial plateau, was not uncommon in clinic. Medial stenosis was the most type of the disease. The symptoms included knee pain during walking and varus deformity of lower limbs. Total knee arthroplasty and tibial osteotomy were two common conventional treatment of the knee osteoarthritis, which were not minimally invasive and bring great financial burden to patients' family. The investigators planned to recruit 150 patients of knee osteoarthritis into this study, which were randomly divided into two groups (study group and control group). 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. However, total knee arthroplasty was conducted for the patients of control group. The patients were followed up and the clinical outcomes were compared in this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
balanced buttress absorbable spacer
Arm Type
Experimental
Arm Description
For the patients of study group, a balanced buttress absorbable spacer was placed into tibia.
Arm Title
total knee arthroplasty
Arm Type
Placebo Comparator
Arm Description
For the patients of control group, total knee arthroplasty was conducted.
Intervention Type
Device
Intervention Name(s)
balanced buttress absorbable spacer
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
total knee arthroplasty
Intervention Description
Total knee arthroplasty was conducted for the patients of control group
Primary Outcome Measure Information:
Title
functional outcome
Description
walking distance the patients could bear
Time Frame
12 months
Secondary Outcome Measure Information:
Title
complication
Description
vascular nerve bundle injury
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 40-80 years old Medial stenosis of the knee Varus deformity less than 20 degrees Exclusion Criteria: Lateral stenosis of the knee Hepatic renal dysfunction Refuse to participate the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yingze Zhang, M.D
Phone
+8613313012888
Email
yzzhangdr@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ruipeng Zhang, M.D
Phone
+8615613390624
Email
zhangruipengdoctor@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yingze Zhang, M.D
Organizational Affiliation
Third Hospital of Hebei Medical University Department of Orthopaedic Surgery
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Zhiyong Hou, M.D
Organizational Affiliation
Third Hospital of Hebei Medical University Department of Orthopaedic Surgery
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ruipeng Zhang, M.D
Organizational Affiliation
Third Hospital of Hebei Medical University Department of Orthopaedic Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hebei Medical University Third Hospital
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050051
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yingze Zhang, M.D
Phone
+8613313012888
Email
yzzhangdr@126.com
Facility Name
Zhiyong Hou
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050051
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhiyong Hou, M.D
Phone
+8618533112800
Email
houzhiyong1234@126.com
First Name & Middle Initial & Last Name & Degree
Ruipeng Zhang, M.D

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

The Treatment of Knee Osteoarthritis With Balanced Buttress Absorbable Spacer

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