The Treatment of Knee Osteoarthritis With Balanced Buttress Absorbable Spacer

Phase 3

• Conditions: Osteoarthritis, Knee
• Interventions: Device: balanced buttress absorbable spacer; Biological: total knee arthroplasty

• Registration Number: NCT03060382
• Lead Sponsor: Hebei Medical University Third Hospital

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.

Study Timeline

• Study Start: 2017-01
• Status Verified: 2017-02
• Study First Submitted: 2017-02-18
• Study First Submitted QC: 2017-02-21
• Study First Posted: 2017-02-23
• Last Update Submitted: 2017-06-22
• Last Update Posted: 2017-06-23
• Primary Completion: 2018-01
• Study Completion: 2019-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
balanced buttress absorbable spacer	balanced buttress absorbable spacer	For the patients of study group, a balanced buttress absorbable spacer was placed into tibia.
total knee arthroplasty	total knee arthroplasty	For the patients of control group, total knee arthroplasty was conducted.

Primary Outcome Measures

Name	Time	Method
functional outcome	12 months	walking distance the patients could bear

Secondary Outcome Measures

Name	Time	Method
complication	1 week	vascular nerve bundle injury

Trial Locations

Locations (2)

Hebei Medical University Third Hospital; 🇨🇳 Shijiazhuang, Hebei, China

Zhiyong Hou; 🇨🇳 Shijiazhuang, Hebei, China