The Treatment of Knee Osteoarthritis With Balanced Buttress Absorbable Spacer

Hebei Medical University Third Hospital

Status and phase: Unknown; Phase 3

Conditions: Osteoarthritis, Knee

Treatments: Biological: total knee arthroplasty; Device: balanced buttress absorbable spacer

Study type: Interventional

Funder types: Other

Identifiers

NCT03060382

DP2017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups, including a placebo group

balanced buttress absorbable spacer

Experimental group

Description:

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

Treatment:

Device: balanced buttress absorbable spacer

total knee arthroplasty

Placebo Comparator group

Description:

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

Treatment:

Biological: total knee arthroplasty