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Tibial plateau hybrid fixation prosthesis for primary total knee arthroplasty in patients with osteoporosis: a multicenter observational study

Tibial plateau hybrid fixation prosthesis for primary total knee arthroplasty in patients with osteoporosis: a multicenter observational study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500103111
Enrollment
Unknown
Registered
2025-05-26
Start date
2025-06-01
Completion date
Unknown
Last updated
2025-06-02

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

Conditions

Osteoarthritis of knee joint

Interventions

TMK mixed fixed prosthesis:None
TMK cement fixed prosthesis:None

Sponsors

The First Affiliated Hospital, College of Medicine, Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. The age is over 50 years old. 2. According to the physical examination and the history of knee osteoarthritis confirmed by clinical and radiology 3. The first total knee arthroplasty is proposed. 4. Diagnosed osteoporosis / osteopenia

Exclusion criteria

Exclusion criteria: 1. There have been deformities caused by severe joint trauma in the past. 2. Hemiplegia of limbs and poor muscle strength of lower extremities. 3. Can't tolerate surgery 4. There is a bone defect in the knee joint before operation. 5. Body mass index (BMI) is higher than 40kg/m^2 6. Any joint or whole body has active infection or suspected infection 7. Refuse to sign informed consent form and fail to complete regular follow-up

Design outcomes

Primary

MeasureTime frame
Displacement of tibial plateau;KSS score;VAS pain score;Joint amnesia score and joint range of motion;

Secondary

MeasureTime frame
Basic information;

Countries

China

Contacts

Public ContactPengfei Lei

The First Affiliated Hospital, College of Medicine, Zhejiang University

leipengfei@zju.edu.cn+86 571 8723 3531

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026