Comparison of synthetic vs allograft in the treatment of tibial plateau fractures

Comparison of articular depression of OsvehOss synthetic graft vs allograft in the treatment of Schatzker type 2 and 3 tibial plateau fractures: a randomized clinial trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20160513027872N3

Enrollment

Registered

2023-09-04

Start date

2023-08-23

Completion date

Unknown

Last updated

2023-10-16

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

Conditions

tibial plateau fractures. Fracture of lateral condyle of tibia

Interventions

Intervention 1: Intervention Group: Patients in this group will receive the OsvehOss synthetic graft procedure. All patients will receive the same standard surgical treatment.The procedure will be per

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Age range: 18-75 years old The time spent from the fracture is less than three weeks Close fracture Schatzker type 2 and 3 tibial plateau fractures Articular depression more than 3 mm Limited soft tissue damage (Tscherne<3)

Exclusion criteria

Exclusion criteria: History of bone metabolic disorders History of uncontrolled diabetes mellitus Glucocorticoids use History of immunosuppressive and rheumatologic diseases Pregnancy or Lactation Having active cancer A fracture in the same limb provided that it affects the rehabilitation or fusion process. For example, a concomitant fracture of the distal femur Pathological fractures Patient's unwillingness to participate

Design outcomes

Primary

Measure	Time frame
Articular depression in millimeter. Timepoint: Pre-operation, immediately post-operation, and 6 and 12 months following the operation. Method of measurement: The depression will be measured using CT-scan in the scale of millimeter.	—

Secondary

Measure	Time frame
Lower extremity functional scale (LEFS). Timepoint: 6 and 12 months following surgery. Method of measurement: Using the cross-cultural validated Persian version of the LEFS.;Visual analog score pain (VAS). Timepoint: 6 and 12 months following surgery. Method of measurement: The scale varied from 0 to 10 based on the patient's severity of pain.;Lyshom Knee Score. Timepoint: 6 and 12 months following surgery. Method of measurement: Using the cross-cultural validated Persian version of the LEFS.	—

Measure

Time frame

Lower extremity functional scale (LEFS). Timepoint: 6 and 12 months following surgery. Method of measurement: Using the cross-cultural validated Persian version of the LEFS.;Visual analog score pain (VAS). Timepoint: 6 and 12 months following surgery. Method of measurement: The scale varied from 0 to 10 based on the patient's severity of pain.;Lyshom Knee Score. Timepoint: 6 and 12 months following surgery. Method of measurement: Using the cross-cultural validated Persian version of the LEFS.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactSayyed-Hadi Sayyed-Hosseinian

Mashhad University of Medical Sciences

HoseinianH@mums.ac.ir+98 51 3852 0028

Outcome results

None listed

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