The Treatment of Knee Osteoarthritis With Balanced Buttress Absorbable Spacer

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03060382

Enrollment

150

Registered

2017-02-23

Start date

2017-01-31

Completion date

2019-01-31

Last updated

2017-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Knee

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.

Interventions

DEVICEbalanced 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.

BIOLOGICALtotal knee arthroplasty

Total knee arthroplasty was conducted for the patients of control group

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

40 Years to 80 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
functional outcome	12 months	walking distance the patients could bear

Secondary

Measure	Time frame	Description
complication	1 week	vascular nerve bundle injury

Countries

China

Contacts

Primary ContactYingze Zhang, M.D

yzzhangdr@126.com+8613313012888

Backup ContactRuipeng Zhang, M.D

zhangruipengdoctor@126.com+8615613390624

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026