3D-Printed Grafts for Knee Cartilage Repair

Condition(s) studied

Investigational drug(s) / intervention(s)

3D-Printed Scaffold-Assisted PRP Combined with Autologous Periosteal-Bone Grafting: 3D-Printed Scaffold-Assisted PRP Combined with Autologous Periosteal-Bone Grafting

3D Printing-Assisted Autologous Periosteal-Bone Grafting: 3D Printing-Assisted Autologous Periosteal-Bone Grafting

Study summary

Research Title:A study on 3D printing-assisted platelet-rich plasma combined with autologous periosteum-bone grafting in the treatment of knee cartilage injury Objectives:(1) To evaluate the accuracy of cartilage damage repair by measuring the chimerism and surface curvature matching degree of 3D printing reconstruction. (2) 3D printing assisted platelerichplasma (PRP) combined with autologous periosteumBone grafting in patients with knee cartilage injury was evaluated for functional and imaging scores to evaluate the clinical effect and cartilage repair effect.

Design Type:Prospective randomized controlled trial Research Objects:Unilateral knee cartilage injury area\>2CM2, international cartilagerepair society (ICRS) grade 3-4 patients Sample size: 60 cases (30 patients with 3D printing-assisted autologous periosteum-bone grafting, 3D printing-assisted PRP combined with autologous periosteum.) - 30 patients with bone grafting).Selection Criteria:(1) Age 18\~65 years old; (2) The body mass index (BMI) is 18\~30kg/m2 ； (3) Knee cartilage injury confirmed by imaging examination, knee cartilage injury 2\>cm2, ICRS grade 3-4; (4) There is no obvious abnormality in the lower limb force line; (5) No other drug injection or surgical treatment has been performed locally in the knee joint in the past 1 year.

Observation indicators:(1) Clinical function(2) Imaging evaluation: Bilateral knee MRI examination was performed on the second day after surgery Statistical analysis methods:SPSS software was used for data analysis.

Eligibility

Primary outcome measure(s)

• Clinical function — 1 year
  (1) Clinical function: Knee joint obtained by outpatient follow-up, written questionnaires, or by telephone by trained medical professionals before surgery and 1, 3, 6, and 12 months after surgery Lysholm score, Tegner exercise ability score, and pain numeric score were used to assess the improvement of symptoms and function.Lysholm score：minimum：0，maximum：80，a higher score represents a better outcome；Tegner exercise ability score：minimum：0，maximum：80，a higher score represents a better outcome；pain numeric score：minimum：0，maximum：10，a higher score represents a worse outcome.）

Trial sites (1)

More Second Affiliated Hospital of Nanchang University trials in China