The Treatment of Knee Osteoarthritis With Balanced Buttress Absorbable Spacer

Osteoarthritis, Knee Clinical Trial

Official title:

The Treatment of Knee Osteoarthritis With Balanced Buttress Absorbable Spacer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03060382
• Other study ID #: DP2017
• Status: Recruiting
• Phase: Phase 3
• First received: February 18, 2017
• Last updated: June 22, 2017
• Start date: January 2017
• Est. completion date: January 2019

Study information

• Verified date: February 2017
• Source: Hebei Medical University Third Hospital
• Contact: Yingze Zhang, M.D
• Phone: +8613313012888
• Email: yzzhangdr[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: January 2019
• Est. primary completion date: January 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• 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.

Biological:
• total knee arthroplasty
Total knee arthroplasty was conducted for the patients of control group

Locations

Country	Name	City	State
China	Hebei Medical University Third Hospital	Shijiazhuang	Hebei
China	Zhiyong Hou	Shijiazhuang	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Hebei Medical University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	functional outcome	walking distance the patients could bear	12 months
Secondary	complication	vascular nerve bundle injury	1 week