Clinical trial NCT06687668: Short Leg Walking Plaster Cast Versus Walking Foot Cast for Jones Fracture
Official title: Short Leg Walking Plaster Cast Versus Walking Foot Cast for Jones Fracture: An Open Label Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Jones Syndrome
Metatarsal Bone Fractures
Keywords: Jones Fracture
Non-Surgical Management
Conservative Treatment
Walking Cast
Plaster Cast Treatment
Lead sponsor: Khyber Medical University Peshawar
Sponsor class: OTHER
First posted: 2024-11-13
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two arms in parallel: One group receives the Short Leg Walking Plaster Cast, and the other receives the Walking Foot Plaster Cast.
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Fracture Union Rate
timeFrame: 6 weeks after cast application.
measure: Delayed Union Rate
timeFrame: 6 weeks, with further assessment at 8 weeks if needed.
measure: Nonunion Rate
timeFrame: 8 weeks post-cast application.
measure: Functional Outcome (American Orthopaedic Foot and Ankle Score - AOFAS)
timeFrame: 6 weeks after cast removal.
Secondary outcomes:
measure: Complication
timeFrame: Throughout the study duration up to 8 weeks.
Other outcomes:
Locations:
city: Peshawar
country: Pakistan
facility: Lady Reading Hospital, Pakistan
state: Khyber Pakhtunkhwa
Study officials:
affiliation: Lady Reading Hospital, Pakistan
name: Dr Faaiz Ali Shah
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.