Haglund's DiseaseNCT07157319
Zadek Osteotomy for Treatment of Haglund's Syndrome
An observational study of Haglund's Disease, run by Sohag University at 1 site in Egypt.
Trial summary
Haglund's syndrome is an abnormality of the bone and soft tissues in the foot. An enlargement of the bony section of the heel (where the Achilles tendon is inserted) triggers this condition. symptom includes insertional Achilles tendinopathy (IAT), The patient with HS often has a red, irritated, painful heel. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Haglund's Disease
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2025to Dec 2025
- Phase
- Observational
- 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
- Adult
Study population: Patients attending and treating in Sohag University Hospital in Upper Egypt
Who may be able to join
- patients over 18 years of age and less than 60 Yrs
- All patients had at least six months of conservative treatment
Who cannot join
- patients below 18 years of age and more than 60 Yrs
- patients of Haglund's syndrome with AT rupture or degeneration
- uncontrolled diabetic patients with or without neuropathic joint destruction,
- Infection such as osteomyelitis.
- Charcot joint.
- Peripheral vascular disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mohamed Kamal Abd Alhakeem Mohamed Kamal Abd Alhakeem, Orthopedics resident, Sohag Un contact
Egypt1 site, 1 recruiting
- Recruiting
Faculty of medicine, Sohag University
Sohag
Mohamed Kamal Abd Alhakeem Mohamed Kamal Abd Alhakeem, Orthopedics resident, Sohag Un, +201550529605, mo.hakeem2020@gmail.com
About this study
Haglund's syndrome is an abnormality of the bone and soft tissues in the foot. An enlargement of the bony section of the heel (where the Achilles tendon is inserted) triggers this condition.
- symptom includes insertional Achilles tendinopathy (IAT), The patient with HS often has a red, irritated, painful heel. And they often complain the enlargement of the posterior heel, which make it more difficult to footwear or sport
- Zadek described the Zadek Osteotomy option for the treatment of Haglund's syndrome This operation can change the calcaneus' anatomical length and elevate the distal insertion point of the Achilles tendon
- It is a prospective case series study that will be done in Orthopedics and Traumatology department of Sohag university hospitals on patients suffering from Haglund's syndrome and treated by Zadek osteotomy
- This study aims to evaluate short term clinical, radiological and functional outcomes of Zadek osteotomy for treatment of Haglund's syndrome
Read the detailed description
Introduction
- In 1928, Patrick Haglund described the Haglund syndrome firstly. Haglund's syndrome is an abnormality of the bone and soft tissues in the foot. An enlargement of the bony section of the heel (where the Achilles tendon is inserted) triggers this condition. The soft tissue near the back of the heel can become irritated when the large, bony lump rubs against rigid shoes.
- symptom includes insertional Achilles tendinopathy (IAT), The patient with HS often has a red, irritated, painful heel. And they often complain the enlargement of the posterior heel, which make it more difficult to footwear or sport.
- There are many conservative treatment options to treat it, which contains rest, activity modification, ice, or footwear modification.
- When these treatment for more than 6 months has failed, surgical options will be considered.
- Common surgical methods, including Haglund deformity debridement, endoscopic calcaneoplasty, and Zadek osteotomy (ZO).
- Zadek described the ZO option for the treatment of HS firstly. It was later modified by Keck and ZO is a dorsal closing wedge calcaneal osteotomy that allows the tuberosity of Haglund deformity to be brought forward. This operation can change the calcaneus' anatomical length and elevate the distal insertion point of the AT.
Aim of the work
- This study aims to evaluate short term clinical, radiological and functional outcomes of Zadek osteotomy for treatment of Haglund's syndrome.
Patients and Methods
- It is a prospective case series study that will be done in Orthopedics and Traumatology department of Sohag university hospitals on patients suffering from Haglund's syndrome and treated by Zadek osteotomy
- We are aiming in this study to include patients within period between 4/2025 to 10/2025
- Conditions
- Haglund's Disease
- Keywords
- Zadek osteotomy for treatment of Haglund's syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcomes for a Zadek osteotomy in Haglund's syndrome include: pain relief.
- Pain Reduction: Marked improvement in pain, often measured by a Visual Analogue Scale (VAS) score, is a primary outcome, with significant reductions in pain intensity and frequency reported after the procedure.
Measured: From enrollment and follow up to the end of 24 weeks
functional improvement (measured by score VISA-A).
Functional Improvement:
VISA-A (Visual Analogue Scale for Achilles Tendinopathy) Score: A successful outcome is characterized by an improvement in the VISA-A score, reflecting better function for the Achilles tendon.
Measured: From enrollment and follow up to the end of 24 weeks
radiological changes to the calcaneus
calcaneal length and tuberosity ratio (X/Y Ratio): The osteotomy modifies the calcaneus by shortening it and rotating the posterosuperior tuberosity, which reduces impingement on the Achilles tendon.
calcaneal pitch angle(calcaneal inclination angle): Studies have shown a reduction in the calcaneal pitch angle after Zadek osteotomy which is a relevant radiological parameter for Haglund's deformity
Measured: From enrollment and follow up to the end of 24 weeks
improved ankle motion (dorsiflexion),
Improvements in scores like the Tegner scale show a patient's ability to return to sports or other activities at a pre-injury level The Zadek osteotomy is known to improve the range of motion, specifically an increase in ankle dorsiflexion.
Measured: From enrollment and follow up to the end of 24 weeks
Patient Satisfaction:
High rates of patient satisfaction are a key indicator of a successful procedure, with many patients reporting positive experiences post-surgery
Measured: From enrollment and follow up to the end of 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start1 Apr 2025
- Primary completionOct 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Haglund's DiseaseStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Kamal Abdelhakeem, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07157319
- Sponsor's protocol ID
- soh-Med--25-8-2MS
- Status last verified
- Aug 2025
- First submitted
- 14 Aug 2025
- Last updated
- 5 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zadek Osteotomy for Treatment of Haglund's Syndrome
- ClinicalTrials.gov ID
- NCT07157319
- Acronym / sponsor ID
- soh-Med--25-8-2MS
- Conditions
- Haglund's Disease
- Keywords
- Zadek osteotomy for treatment of Haglund's syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 5 Sep 2025 (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.
Haglund's syndrome is an abnormality of the bone and soft tissues in the foot. An enlargement of the bony section of the heel (where the Achilles tendon is inserted) triggers this condition.
- symptom includes insertional Achilles tendinopathy (IAT), The patient with HS often has a red, irritated, painful heel. And they often complain the enlargement of the posterior heel, which make it more difficult to footwear or sport
- Zadek described the Zadek Osteotomy option for the treatment of Haglund's syndrome This operation can change the calcaneus' anatomical length and elevate the distal insertion point of the Achilles tendon
- It is a prospective case series study that will be done in Orthopedics and Traumatology department of Sohag university hospitals on patients suffering from Haglund's syndrome and treated by Zadek osteotomy
- This study aims to evaluate short term clinical, radiological and functional outcomes of Zadek osteotomy for treatment of Haglund's syndrome
Detailed description
Introduction
- In 1928, Patrick Haglund described the Haglund syndrome firstly. Haglund's syndrome is an abnormality of the bone and soft tissues in the foot. An enlargement of the bony section of the heel (where the Achilles tendon is inserted) triggers this condition. The soft tissue near the back of the heel can become irritated when the large, bony lump rubs against rigid shoes.
- symptom includes insertional Achilles tendinopathy (IAT), The patient with HS often has a red, irritated, painful heel. And they often complain the enlargement of the posterior heel, which make it more difficult to footwear or sport.
- There are many conservative treatment options to treat it, which contains rest, activity modification, ice, or footwear modification.
- When these treatment for more than 6 months has failed, surgical options will be considered.
- Common surgical methods, including Haglund deformity debridement, endoscopic calcaneoplasty, and Zadek osteotomy (ZO).
- Zadek described the ZO option for the treatment of HS firstly. It was later modified by Keck and ZO is a dorsal closing wedge calcaneal osteotomy that allows the tuberosity of Haglund deformity to be brought forward. This operation can change the calcaneus' anatomical length and elevate the distal insertion point of the AT.
Aim of the work
- This study aims to evaluate short term clinical, radiological and functional outcomes of Zadek osteotomy for treatment of Haglund's syndrome.
Patients and Methods
- It is a prospective case series study that will be done in Orthopedics and Traumatology department of Sohag university hospitals on patients suffering from Haglund's syndrome and treated by Zadek osteotomy
- We are aiming in this study to include patients within period between 4/2025 to 10/2025
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- Patients attending and treating in Sohag University Hospital in Upper Egypt
Key inclusion criteria (2 listed)
- patients over 18 years of age and less than 60 Yrs
- All patients had at least six months of conservative treatment
Key exclusion criteria (6 listed)
- patients below 18 years of age and more than 60 Yrs
- patients of Haglund's syndrome with AT rupture or degeneration
- uncontrolled diabetic patients with or without neuropathic joint destruction,
- Infection such as osteomyelitis.
- Charcot joint.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Primary outcomes for a Zadek osteotomy in Haglund's syndrome include: pain relief.
Time frame: From enrollment and follow up to the end of 24 weeks
- Pain Reduction: Marked improvement in pain, often measured by a Visual Analogue Scale (VAS) score, is a primary outcome, with significant reductions in pain intensity and frequency reported after the procedure.
functional improvement (measured by score VISA-A).
Time frame: From enrollment and follow up to the end of 24 weeks
Functional Improvement: VISA-A (Visual Analogue Scale for Achilles Tendinopathy) Score: A successful outcome is characterized by an improvement in the VISA-A score, reflecting better function for the Achilles tendon.
radiological changes to the calcaneus
Time frame: From enrollment and follow up to the end of 24 weeks
calcaneal length and tuberosity ratio (X/Y Ratio): The osteotomy modifies the calcaneus by shortening it and rotating the posterosuperior tuberosity, which reduces impingement on the Achilles tendon. calcaneal pitch angle(calcaneal inclination angle): Studies have shown a reduction in the calcaneal pitch angle after Zadek osteotomy which is a relevant radiological parameter for Haglund's deformity
improved ankle motion (dorsiflexion),
Time frame: From enrollment and follow up to the end of 24 weeks
Improvements in scores like the Tegner scale show a patient's ability to return to sports or other activities at a pre-injury level The Zadek osteotomy is known to improve the range of motion, specifically an increase in ankle dorsiflexion.
Patient Satisfaction:
Time frame: From enrollment and follow up to the end of 24 weeks
High rates of patient satisfaction are a key indicator of a successful procedure, with many patients reporting positive experiences post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Haglund's Disease
Not yet recruiting
Extracorporeal Shockwave Therapy and Platelet-Rich Plasma for Midportion Achilles Tendinopathy
Achilles Injuries Tendon, Achilles Tendinopathy (AT)
RecruitingObservational study
Embo Registry; National Registry for Artery Embolization
Chronic Pain, Osteoarthritis, Knee
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.
Mohamed Kamal Abd Alhakeem Mohamed Kamal Abd Alhakeem, Orthopedics resident, Sohag Un contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Haglund's Disease, run by Sohag 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 2 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: looking for participants now, as of the sponsor's last update on 5 Sep 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?
Contact Mohamed Kamal Abd Alhakeem Mohamed Kamal Abd Alhakeem, Orthopedics resident, Sohag Un (+201550529605, mo.hakeem2020@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcomes for a Zadek osteotomy in Haglund's syndrome include: pain relief. (time frame: From enrollment and follow up to the end of 24 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Sep 2025.