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Calcaneus FracturesNCT07111897

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

A study testing percutaneous cannulated screw fixation and Plate fixation in people with Calcaneus Fractures, run by Ain Shams University at 1 site in Egypt.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Calcaneus Fractures
What is being tested?
percutaneous cannulated screw fixation and Plate fixation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteEgypt
Study dates
15 May 2025to 1 Nov 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Faculty Of Medicine, Ain Shams university.

    Cairo, Cairo Governorate

Other trials in Egypt

About this study

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.

Being tested
percutaneous cannulated screw fixation, Plate fixation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • percutaneous cannulated screw fixationProcedure or surgery

    fixation of calcaneal fractures by cannulated screws inserted percutaneously

  • Plate fixationProcedure or surgery

    Also called osteosynthesis

    Fixation of calcaneal fracture by plate.

Study groups in NCT07111897
Study groupRoleWhat they receive
Percutaneous Cannulated ScrewsExperimentalNot described
Receives: Procedure: percutaneous cannulated screw fixation
Plate FixationExperimentalFixation of calcaneal fracture by plate
Receives: Procedure: Plate fixation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Bohler Angle

    Measured: Preoperative, immediate postoperative, and at 6 months.

  2. Gissane Angle

    Measured: Preoperative, immediate postoperative, and at 6 months.

  3. AOFAS Score

    Measured: At 6 months.

  4. Calcaneal width

    Measured: Preoperative, immediate postoperative, and at 6 months.

  5. Calcaneal height

    Measured: Preoperative, immediate postoperative, and at 6 months.

  6. Calcaneal length

    Measured: Preoperative, immediate postoperative, and at 6 months.

  7. Surgical time

    Measured: intra-operative

Secondary outcomes (3)

  1. Time to union

    Measured: at radiological evidence of healing, in 6 weeks.

  2. Subtalar Arthritis

    Measured: At 6 months.

  3. Complication Rate

    Measured: At 6 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2025
  2. Study start15 May 2025
  3. Primary completion28 Jun 2025
  4. Study completion1 Nov 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07111897
Sponsor's protocol ID
MS297/2025
Status last verified
May 2025
First submitted
24 Jul 2025
Last updated
8 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: For property rights and privacy protection

Publications

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing percutaneous cannulated screw fixation and Plate fixation in people with Calcaneus Fractures, run by Ain Shams University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bohler Angle (time frame: Preoperative, immediate postoperative, and at 6 months.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07111897, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025; AzTrials last refreshed its copy on 6 Nov 2026.

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