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

NCT ID: NCT06687668

Last Updated: 2025-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-13

Study Completion Date

2025-04-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Jones Syndrome Metatarsal Bone Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two arms in parallel: One group receives the Short Leg Walking Plaster Cast, and the other receives the Walking Foot Plaster Cast.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

No masking due to the visible nature of the interventions (type of plaster cast), but the outcomes assessor is blinded to treatment assignment when evaluating follow-up outcomes.

Study Groups

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Short Leg Walking Plaster Cast

Participants in this group will receive a short leg walking plaster cast, extending from the metatarsal heads up to the mid-calf. This cast limits mobility at the fracture site while allowing partial weight-bearing as tolerated. Participants will use this cast for six weeks, with follow-up for fracture healing and functional outcome at the end of the treatment period.

Group Type EXPERIMENTAL

Short Leg Walking Plaster Cast

Intervention Type 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

Participants in this group will receive a walking foot plaster cast, which provides support to the foot while allowing more flexibility around the ankle. This cast restricts movement to avoid further injury while enabling weight-bearing activities as tolerated. The cast will be worn for six weeks, with follow-up assessments for fracture healing and functional outcome after this period.

Group Type ACTIVE_COMPARATOR

Walking Foot Plaster Cast

Intervention Type 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.

Interventions

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Short Leg Walking Plaster Cast

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.

Intervention Type OTHER

Walking Foot Plaster Cast

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Khyber Medical University Peshawar

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dr Faaiz Ali Shah

Role: PRINCIPAL_INVESTIGATOR

Lady Reading Hospital, Pakistan

Locations

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Lady Reading Hospital, Pakistan

Peshawar, Khyber Pakhtunkhwa, Pakistan

Site Status

Countries

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Pakistan

References

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Buskova K, Bartonicek J, Rammelt S. Fractures of the Base of the Fifth Metatarsal Bone: A Critical Analysis Review. JBJS Rev. 2021 Oct 21;9(10). doi: 10.2106/JBJS.RVW.21.00010.

Reference Type BACKGROUND
PMID: 34673663 (View on PubMed)

de Ruijter MA, Yuan JZ, Derksen RJ. The Clinical Outcomes of Operative Treatment Versus Conservative Treatment for Dancer's Fractures: Protocol for a Retrospective Cohort Study. JMIR Res Protoc. 2022 Apr 5;11(4):e37171. doi: 10.2196/37171.

Reference Type BACKGROUND
PMID: 35380544 (View on PubMed)

Park JY, Kim HN, Hyun YS, Park JS, Kwon HJ, Kang SH, Kim GL. Effect of Weight-Bearing in Conservative and Operative Management of Fractures of the Base of the Fifth Metatarsal Bone. Biomed Res Int. 2017;2017:1397252. doi: 10.1155/2017/1397252. Epub 2017 Dec 26.

Reference Type BACKGROUND
PMID: 29441351 (View on PubMed)

Other Identifiers

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KMU/DIR/CTU/2024/010

Identifier Type: -

Identifier Source: org_study_id

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