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Completed

NCT Number: NCT06687668

Short Leg Walking Plaster Cast Versus Walking Foot Cast for Jones Fracture

This study is an open-label, randomized controlled trial comparing the effectiveness of two plaster cast methods-Short Leg Walking Plaster Cast and Walking Foot Plaster Cast-for treating Jones fractures, a common fracture at the base of the fifth metatarsal in the foot. This trial will be conducted at Lady Reading Hospital Peshawar. The study will evaluate differences in fracture healing and functional outcomes between these two treatment approaches. Findings from this trial may guide more evidence-based treatment protocols for Jones fractures, potentially improving patient mobility and recovery without requiring surgical intervention.

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Key information

Conditions

Jones Syndrome Metatarsal Bone Fractures

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lady Reading Hospital, Pakistan

Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan

About this study

Jones fractures represent 26.3% of fractures at the base of the fifth metatarsal and are commonly treated conservatively through various weight-bearing casts. The lack of consensus on the optimal casting method for Jones fractures necessitates further study, particularly given the absence of published guidelines. This trial, unique in its randomized and prospective approach within Pakistan, aims to compare Short Leg Walking Plaster Casts and Walking Foot Plaster Casts specifically for Jones fractures.

Patients meeting the inclusion criteria will be randomly assigned to one of the two treatment groups, with the primary endpoints being fracture healing (union) and functional outcomes at six weeks, assessed via radiographs and the American Orthopaedic Foot and Ankle Score (AOFAS). This study seeks to produce robust evidence to inform treatment guidelines, allowing patients, especially in low- and middle-income settings, to continue daily activities with minimal disruption during recovery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Both genders
  • 18 years and above
  • Jones fractures that are un-displaced or minimally displaced (less than 2 mm)
  • Fractures presented within 7 days of injury

Exclusion criteria

  • Significant foot swelling
  • Open fractures
  • Ipsilateral foot, ankle, or lower limb soft tissue pathology or fractures
  • Pathological fractures

Treatment and study plan

Short Leg Walking Plaster Cast

Other

A short leg walking plaster cast that extends from the head of the metatarsal to the mid-calf. This cast provides stability to the fracture site while allowing limited weight-bearing, and is designed to restrict inversion and eversion movements, thereby reducing the risk of fracture displacement. Applied for six weeks.

Walking Foot Plaster Cast

Other

A walking foot plaster cast that covers the foot from the metatarsal heads but leaves the toes exposed. This cast allows weight-bearing while restricting side-to-side movement, providing support to the fracture area without immobilizing the ankle. It will be used for six weeks.

Primary outcomes

  1. Fracture Union Rate

    Time frame: 6 weeks after cast application.

    Measurement of fracture healing defined by callus formation and obliteration of the fracture line in 2 out of 3 cortices (lateral, medial, plantar) on X-ray, and absence of pain and tenderness at the fracture site, assessed by a senior orthopedic consultant.

  2. Delayed Union Rate

    Time frame: 6 weeks, with further assessment at 8 weeks if needed.

    Defined by insufficient callus in fewer than 2 cortices and persistent pain and tenderness at the fracture site. This assessment determines cases where additional casting or intervention may be necessary.

  3. Nonunion Rate

    Time frame: 8 weeks post-cast application.

    Nonunion is confirmed if there is insufficient callus formation in fewer than 2 cortices, with persistent pain and tenderness at the fracture site.

  4. Functional Outcome (American Orthopaedic Foot and Ankle Score - AOFAS)

    Time frame: 6 weeks after cast removal.

    Functional outcome assessed via the AOFAS scoring system, which includes pain (40 points), function (50 points), and alignment (10 points), with higher scores indicating better function.

Secondary outcomes

  1. Complication

    Time frame: Throughout the study duration up to 8 weeks.

    Incidence of any complications, such as cast-related issues, skin irritation, or infection, during and after cast application.

Sponsors and collaborators

Lead sponsor

Khyber Medical University Peshawar

Other

Registry information

Official study title

Short Leg Walking Plaster Cast Versus Walking Foot Cast for Jones Fracture: An Open Label Randomized Controlled Trial.

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 13, 2024
Registry last updated
Jun 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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