Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| balanced buttress absorbable spacer | Experimental | For the patients of study group, a balanced buttress absorbable spacer was placed into tibia. |
|
| total knee arthroplasty | Placebo Comparator | For the patients of control group, total knee arthroplasty was conducted. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| balanced buttress absorbable spacer | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| functional outcome | walking distance the patients could bear | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| complication | vascular nerve bundle injury | 1 week |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yingze Zhang, M.D | Contact | +8613313012888 | yzzhangdr@126.com | |
| Ruipeng Zhang, M.D | Contact | +8615613390624 | zhangruipengdoctor@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Yingze Zhang, M.D | Third Hospital of Hebei Medical University Department of Orthopaedic Surgery | Study Chair |
| Zhiyong Hou, M.D | Third Hospital of Hebei Medical University Department of Orthopaedic Surgery | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hebei Medical University Third Hospital | Recruiting | Shijiazhuang | Hebei | 050051 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D019645 | Arthroplasty, Replacement, Knee |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| total knee arthroplasty | Biological | Total knee arthroplasty was conducted for the patients of control group |
|
| Ruipeng Zhang, M.D | Third Hospital of Hebei Medical University Department of Orthopaedic Surgery | Principal Investigator |
| Zhiyong Hou | Recruiting | Shijiazhuang | Hebei | 050051 | China |
|
| D012216 |
| Rheumatic Diseases |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |