Evaluation of safety and efficiency of a three-dimensional printed patient-specific cutting guides in open-wedge high tibial osteotomy:a randomized controlled trial

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000038619

Enrollment

Unknown

Registered

2020-09-26

Start date

2020-09-15

Completion date

Unknown

Last updated

2020-12-07

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

Conditions

Knee osteoarthritis

Interventions

Experimental group:Three-dimensional printed patient-specific cutting guides group will be used to assist high tibial osteotomy

Control group:Three-dimensional printed patient-specific cutting guides group was not used to assist high tibial osteotomy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Imaging findings showed that the medial space of knee joint was narrowed, and the subchondral bone could appear hardening; 2. Varus deformity was originated from the proximal tibia, no stenosis was found in the lateral joint space, the free body in the joint was not serious, and patellofemoral track was great; 3. Aged 90 degree), tibial varus deformity >5 degree, medial proximal tibial angle (MPTA)<85 degree, knee joint flexion contracture deformity <10 degree, great joint stability, normal lateral cartilage and meniscus function.

Exclusion criteria

Exclusion criteria: 1. The patient's knee pain is not confined to the medial or anterior medial side, or the imaging manifestations are multi-joint compartment and patellofemoral joint lesions; 2. Varus deformity >30 degree, flexion contracture >15 degree, knee joint stability is poor, ligament function is unstable; 3. According to the preoperative knee joint X-ray of the patient, the degree of knee arthritis lesions was graded, and exclude those above Kellgren-Lawrence III; 4. Hemiplegia or poor muscle strength of lower limbs; 5. Cannot tolerate surgery; 6. Body mass index (BMI) >30kg/m2; 7. Excluding patients with non-osteoarthritis such as gout arthritis, rheumatoid arthritis and hemophilia arthritis; 8. Patients with poor compliance and timely review.

Design outcomes

Primary

Measure	Time frame
medial proximal tibial angle, MPTA;weight bearing line;Preoperative correction angle, PreCA;Postoperative correction angle,PostCA;posterior tibial slope angle, PTSA;HSS scores;VAS scores;The operation time;Intraoperative blood loss;Number of intraoperative fluoroscopy;	—

Countries

China

Contacts

Public ContactZhong Da

Department of Orthopedics, Xiangya Hospital, Central South University

dr_zhongda@126.com+86 13574890378

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 17, 2026