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

NCT07111897 | Active Not Recruiting DMC

• 1 other identifier: MS297/2025
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (7)

• Bohler Angle

  Preoperative, immediate postoperative, and at 6 months.

• Gissane Angle

  Preoperative, immediate postoperative, and at 6 months.

• AOFAS Score

  At 6 months.

• Calcaneal width

  Preoperative, immediate postoperative, and at 6 months.

• Calcaneal height

  Preoperative, immediate postoperative, and at 6 months.

• Calcaneal length

  Preoperative, immediate postoperative, and at 6 months.

• Surgical time

  intra-operative

Secondary Outcomes (3)

• Time to union

  at radiological evidence of healing, in 6 weeks.

• Subtalar Arthritis

  At 6 months.

• Complication Rate

  At 6 months.

Study Arms (2)

Percutaneous Cannulated Screws

EXPERIMENTAL

Procedure: percutaneous cannulated screw fixation

Plate Fixation

EXPERIMENTAL

Fixation of calcaneal fracture by plate

Procedure: Plate fixation

Interventions

percutaneous cannulated screw fixation PROCEDURE

fixation of calcaneal fractures by cannulated screws inserted percutaneously

Percutaneous Cannulated Screws

Plate fixation PROCEDURE

Fixation of calcaneal fracture by plate.

Also known as: osteosynthesis

Plate Fixation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with calcaneal fractures according to Sanders classification are Sanders type II or type III.
• Closed calcaneal fracture.
• Patients aged 18-60.

You may not qualify if:

• Patients with calcaneal fractures classified as Sanders type I or IV.
• Open calcaneal fractures.
• Patients with systemic comorbidities preventing surgical intervention (unfit patients).
• Patients younger than 18 years old or older than 60.
• Patients with associated spinal fractures.
• Patients with other fractures in the same limb.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty Of Medicine, Ain Shams university.

Cairo, Cairo Governorate, Egypt

Location

Related Publications (1)

• 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

  BACKGROUND

MeSH Terms

Interventions

Fracture Fixation, Internal

Intervention Hierarchy (Ancestors)

Fracture Fixation; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Study Officials

• Awab A. Moussa, MD Candidate

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: August 8, 2025
• Study Start: May 15, 2025
• Primary Completion: June 28, 2025
• Study Completion: November 1, 2025
• Last Updated: August 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)