Plate Fixation Versus Percutaneous Cannulated Screw Insertion in Sanders Type II and Type III Calcaneal Fractures

NCT ID: NCT07111897

Last Updated: 2025-08-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-15
• Study Completion Date: 2025-11-01

Brief Summary

Sanders Ⅱ and Ⅲ intra-articular calcaneal fractures primarily result from falls from height, often accompanied by severe flap soft tissue injury and notable displacement of fracture fragments, which can pose significant reconstruction challenges. The traditional "L" lateral incision open reduction and internal fixation technique is considered the gold standard for the surgical treatment of calcaneal fractures. This trial aims to demonstrate that Percutaneous Cannulated Screws are not inferior to open reduction and internal fixation (ORIF) with plates in the treatment of calcaneal fractures.

Conditions

Calcaneus Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Percutaneous Cannulated Screws

Group Type: EXPERIMENTAL

percutaneous cannulated screw fixation

Intervention Type: PROCEDURE

fixation of calcaneal fractures by cannulated screws inserted percutaneously

Plate Fixation

Fixation of calcaneal fracture by plate

Group Type: EXPERIMENTAL

Plate fixation

Intervention Type: PROCEDURE

Fixation of calcaneal fracture by plate.

Interventions

percutaneous cannulated screw fixation

fixation of calcaneal fractures by cannulated screws inserted percutaneously

Intervention Type: PROCEDURE

Plate fixation

Fixation of calcaneal fracture by plate.

Intervention Type: PROCEDURE

Other Intervention Names

osteosynthesis

Eligibility Criteria

Inclusion Criteria

1. Patients with calcaneal fractures according to Sanders classification are Sanders type II or type III.

2. Closed calcaneal fracture.

3. Patients aged 18-60.

Exclusion Criteria

1. Patients with calcaneal fractures classified as Sanders type I or IV.

2. Open calcaneal fractures.

3. Patients with systemic comorbidities preventing surgical intervention (unfit patients).

4. Patients younger than 18 years old or older than 60.

5. Patients with associated spinal fractures.

6. Patients with other fractures in the same limb.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Awab A. Moussa, MD Candidate

Role: STUDY_DIRECTOR

Faculty of Medicine, Ain shams university, Cario, Egypt.

Locations

Faculty Of Medicine, Ain Shams university.

Cairo, Cairo Governorate, Egypt

Countries

Egypt

References

1. Rockwood Ca Jr, Greene DP. Rockwood and Green's fractures in adults. 4th ed. Philadelphia: Lippincott-Raven; 1996. p. 2405-62. 2. Mitchell MJ, McKinley JC, Robinson CM. The epidemiology of calcaneal fractures. Foot (Edinb). 2009 Dec;19(4):197-200. doi: 10.1016/j.foot.2009.05.001. PMID: 20307476. 3. Sanders R, Fortin P, DiPasquale T, Walling A. Operative treatment in 120 displaced intraarticular calcaneal fractures. Results using a prognostic computed tomography scan classification. Clin Orthop Relat Res. 1993 May;(290):87-95. PMID: 8472475IF: 4.2 Q1. 4. Yeo, J. H., Cho, H. J., & Lee, K. B. (2015). Comparison of two surgical approaches for displaced intra-articular calcaneal fractures: sinus tarsi versus extensile lateral approach. BMC musculoskeletal disorders, 16, 63. https://doi.org/10.1186/s12891-015-0519-0 5. Ibrahim T, Rowsell M, Rennie W, Brown AR, Taylor GJ, Gregg PJ: Displaced intra-articular calcaneal fractures: 15-year follow-up of a randomised controlled trial of conservative versus operative treatment. Injury 2007;38(7):848-855. 6. Gougoulias N, Khanna A, McBride DJ, Maffulli N: Management of calcaneal fractures: Systematic review of randomized trials. Br Med Bull 2009;92:153-167. 7. Swanson SA, Clare MP, Sanders RW: Management of intra-articular fractures of the calcaneus. Foot Ankle Clin 2008;13(4): 659-678. 8. Hsu AR, Anderson RB, Cohen BE. Advances in Surgical Management of Intra-articular Calcaneus Fractures. J Am Acad Orthop Surg. 2015 Jul;23(7):399-407. doi: 10.5435/JAAOS-D-14-00287IF: 2.6 Q1 . PMID: 26111874. 9. Backes, M., Schepers, T., Beerekamp, M. S., Luitse, J. S., Goslings, J. C., & Schep, N. W. (2014). Wound infections following open reduction and internal fixation of calcaneal fractures with an extended lateral approach. International orthopaedics, 38(4), 767-773. https://doi.org/10.1007/s00264-013-2181-1 10. Feng, Y., Shui, X., Wang, J. et al. Comparison of percutaneous cannulated screw fixation and calcium sulfate cement gra

Reference Type: BACKGROUND

Other Identifiers

MS297/2025

Identifier Type: -

Identifier Source: org_study_id