NCT03060382

The Treatment of Knee Osteoarthritis With Balanced Buttress Absorbable Spacer

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Hebei Medical University Third Hospital · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-01-01
• Primary completion: 2018-01-01
• Completion: 2019-01-01
• First posted: 2017-02-23
• Last updated: 2017-06-23

Locations

2 sites across 1 country: China