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An open, single-group, dual-center clinical trial of the safety and efficacy of customized individualized finger joint prosthesis for finger joint replacemen

An open, single-group, dual-center clinical trial of the safety and efficacy of customized individualized finger joint prosthesis for finger joint replacemen

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200055884
Enrollment
Unknown
Registered
2022-01-22
Start date
2022-03-01
Completion date
Unknown
Last updated
2023-07-02

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

Conditions

Finger joint bone injury of hand

Interventions

Intervention group:Customized individualized finger joint prosthesis

Sponsors

Shanghai Sixth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1.Aged 18 to 60 years old (including thresholds); 2.Hand finger joint bone injury or planned/removed tumor, resulting in a bone defect of more than 0.5cm below the articular surface, and those who plan to undergo unilateral finger joint replacement; 3.Those who are unsuitable and/or unwilling to accept autologous bone and joint transplantation due to poor general condition and inability to tolerate prolonged anesthesia; 4.The continuity of the tendon around the joint does not affect the early rehabilitation training after finger joint replacement; 5.Those who agreed to participate in the study and signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Pregnant or lactating women; 2.Unable to communicate or cooperate with medical staff due to neurological, mental illness or language disorder; 3.Serious blood system diseases or other serious diseases such as liver and kidney dysfunction; 4.Known to have a history of allergy to one or more implanted materials; 5.Those who have received finger joint replacement; 6.Two or more finger joints are injured, and other injured fingers may affect the judgment of curative effect after single finger joint replacement according to the judgment of the researcher; 7.Acute or potential infection overall or locally; 8.Congenital deformity and contracture of finger joint; 9.The motor nerve injury of the hand of the affected limb, judged by the researcher, affects the judgment of the curative effect after finger joint replacement; 10.Flexor extensor tendon defect or severe adhesion; 11.Patients with poor skin and soft tissue around the affected finger after one-stage treatment; 12.Bone tumor or soft tissue tumor involving tendon and other joint dynamic system; 13.Those who participated in other clinical trials within 1 month before screening; 14.The investigator believes that it is not suitable to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Excellent rate of joint range of motion;

Countries

China

Contacts

Public ContactYang Qingcheng

Shanghai Sixth People's Hospital

tjyqc@163.com+86 18930177328

Outcome results

None listed

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