Jones SyndromeNCT06687668
Short Leg Walking Plaster Cast Versus Walking Foot Cast for Jones Fracture
A study testing Short Leg Walking Plaster Cast and Walking Foot Plaster Cast in people with Jones Syndrome and Metatarsal Bone Fractures, run by Khyber Medical University Peshawar at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Jones Syndrome, Metatarsal Bone Fractures
- What is being tested?
- Short Leg Walking Plaster Cast and Walking Foot Plaster Cast
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 sitePakistan
- Study dates
- 13 Nov 2024to 28 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Significant foot swelling
- Open fractures
- Ipsilateral foot, ankle, or lower limb soft tissue pathology or fractures
- Pathological fractures
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Lady Reading Hospital, Pakistan
Peshawar, Khyber Pakhtunkhwa, 25000
About this study
Official title: Short Leg Walking Plaster Cast Versus Walking Foot Cast for Jones Fracture: An Open Label Randomized Controlled Trial.
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.
Read the 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.
- Conditions
- Jones Syndrome, Metatarsal Bone Fractures
- Being tested
- Short Leg Walking Plaster Cast, Walking Foot Plaster Cast
- Keywords
- Jones Fracture, Non-Surgical Management, Conservative Treatment, Walking Cast, Plaster Cast Treatment
- Medical subject headings
- Jones syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short Leg Walking Plaster CastOther
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 CastOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Short Leg Walking Plaster Cast | Experimental | 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. Receives: Other: Short Leg Walking Plaster Cast |
| Walking Foot Plaster Cast | Active comparator | 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. Receives: Other: Walking Foot Plaster Cast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fracture Union Rate
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.
Measured: 6 weeks after cast application.
Delayed Union Rate
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.
Measured: 6 weeks, with further assessment at 8 weeks if needed.
Nonunion Rate
Nonunion is confirmed if there is insufficient callus formation in fewer than 2 cortices, with persistent pain and tenderness at the fracture site.
Measured: 8 weeks post-cast application.
Functional Outcome (American Orthopaedic Foot and Ankle Score - AOFAS)
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.
Measured: 6 weeks after cast removal.
Secondary outcomes (1)
Complication
Incidence of any complications, such as cast-related issues, skin irritation, or infection, during and after cast application.
Measured: Throughout the study duration up to 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2024
- Study start13 Nov 2024
- Primary completion10 Apr 2025
- Study completion28 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Jones SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- Two arms in parallel: One group receives the Short Leg Walking Plaster Cast, and the other receives the Walking Foot Plaster Cast.
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khyber Medical University Peshawar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Faaiz Ali Shah, Principal investigator, Lady Reading Hospital, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06687668
- Sponsor's protocol ID
- KMU/DIR/CTU/2024/010
- Status last verified
- Jun 2025
- First submitted
- 12 Nov 2024
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The IPD sharing plan includes making anonymized individual participant data (such as baseline demographics, primary and secondary outcomes, and adverse event data) available to qualified researchers for the purpose of further analysis or replication of the study findings. This data will be shared upon reasonable request and for research purposes only.
Publications
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.
PubMed 34673663de 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.
PubMed 35380544Park 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.
PubMed 29441351
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Leg Walking Plaster Cast Versus Walking Foot Cast for Jones Fracture: An Open Label Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06687668
- Acronym / sponsor ID
- KMU/DIR/CTU/2024/010
- Conditions
- Jones Syndrome, Metatarsal Bone Fractures
- Keywords
- Jones Fracture, Non-Surgical Management, Conservative Treatment, Walking Cast, Plaster Cast Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Khyber Medical University PeshawarUniversity, hospital or other
- Study start
- 13 Nov 2024 (actual)
- Primary completion
- 10 Apr 2025 (actual)
- Study completion
- 28 Apr 2025 (actual)
- First posted
- 13 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two arms in parallel: One group receives the Short Leg Walking Plaster Cast, and the other receives the Walking Foot Plaster Cast.
| Arm | Type | Receives |
|---|---|---|
| Short Leg Walking Plaster Cast | Experimental | Other: Short Leg Walking Plaster CastParticipants 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. |
| Walking Foot Plaster Cast | Active comparator | Other: Walking Foot Plaster CastParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Significant foot swelling
- Open fractures
- Ipsilateral foot, ankle, or lower limb soft tissue pathology or fractures
- Pathological fractures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Short Leg Walking Plaster CastA 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. | Other | Short Leg Walking Plaster Cast |
| Walking Foot Plaster CastA 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. | Other | Walking Foot Plaster Cast |
Primary outcome
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.
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.
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.
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.
1 secondary outcome
Complication
Time frame: Throughout the study duration up to 8 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- Background: PubMed 34673663Buskova 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.
- Background: PubMed 35380544de 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.
- Background: PubMed 29441351Park 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.
- Individual participant dataSharing planned: Yes. The IPD sharing plan includes making anonymized individual participant data (such as baseline demographics, primary and secondary outcomes, and adverse event data) available to qualified researchers for the purpose of further analysis or replication of the study findings. This data will be shared upon reasonable request and for research purposes only.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Faaiz Ali Shah principal investigator
Lady Reading Hospital, Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Short Leg Walking Plaster Cast and Walking Foot Plaster Cast in people with Jones Syndrome and Metatarsal Bone Fractures, run by Khyber Medical University Peshawar at 1 site in Pakistan.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 24 Jun 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 Pakistan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Fracture Union Rate (time frame: 6 weeks after cast application.). The study lists 4 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 NCT06687668, which also lists 3 linked publications.
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 24 Jun 2025.