The Treatment of Knee Osteoarthritis With Balanced Buttress Absorbable Spacer

NCT ID: NCT03060382

Last Updated: 2017-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2019-01-31

Brief Summary

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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

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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.

Conditions

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Osteoarthritis, Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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balanced buttress absorbable spacer

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

Group Type EXPERIMENTAL

balanced buttress absorbable spacer

Intervention Type DEVICE

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

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

Group Type PLACEBO_COMPARATOR

total knee arthroplasty

Intervention Type BIOLOGICAL

Total knee arthroplasty was conducted for the patients of control group

Interventions

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balanced buttress absorbable spacer

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 DEVICE

total knee arthroplasty

Total knee arthroplasty was conducted for the patients of control group

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hebei Medical University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yingze Zhang, M.D

Role: STUDY_CHAIR

Third Hospital of Hebei Medical University Department of Orthopaedic Surgery

Zhiyong Hou, M.D

Role: STUDY_DIRECTOR

Third Hospital of Hebei Medical University Department of Orthopaedic Surgery

Ruipeng Zhang, M.D

Role: PRINCIPAL_INVESTIGATOR

Third Hospital of Hebei Medical University Department of Orthopaedic Surgery

Locations

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Hebei Medical University Third Hospital

Shijiazhuang, Hebei, China

Site Status RECRUITING

Zhiyong Hou

Shijiazhuang, Hebei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yingze Zhang, M.D

Role: CONTACT

+8613313012888

Ruipeng Zhang, M.D

Role: CONTACT

+8615613390624

Facility Contacts

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Yingze Zhang, M.D

Role: primary

+8613313012888

Zhiyong Hou, M.D

Role: primary

+8618533112800

Other Identifiers

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DP2017

Identifier Type: -

Identifier Source: org_study_id

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