NCT07233122

Brief Summary

The aim of this study is to assess role of MRI in detecting synovial, cartilaginous , osseous abnormalities ، bleeding inside knee joint and to use a system for assessing HA as support for therapeutic regimes and for monitoring response to therapy .

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P50-P75 for all trials

Timeline
19mo left

Started Dec 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress22%
Dec 2025Dec 2027

First Submitted

Initial submission to the registry

September 19, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 18, 2025

Completed
13 days until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

November 18, 2025

Status Verified

November 1, 2025

Enrollment Period

2 years

First QC Date

September 19, 2025

Last Update Submit

November 16, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • International Prophylaxis Study Group (IPSG) MRI Score for Hemophilic Arthropathy

    Assessment of knee hemophilic arthropathy severity using the International Prophylaxis Study Group (IPSG) MRI scoring system. This scoring system evaluates early and advanced joint changes such as synovial hypertrophy, hemosiderin deposition, and cartilage/bone damage.

    After completion of MRI scanning session (within the same study visit). Overall Study Duration: 2 years (for recruitment, imaging, and data analysis).

Secondary Outcomes (2)

  • Pettersson X-ray Score for Hemophilic Arthropathy

    After completion of X-ray scanning session (within the same study visit). Overall Study Duration: 2 years (including recruitment, imaging, and data analysis).

  • Agreement Between MRI and X-ray Scoring Systems in Hemophilic Arthropathy

    After completion of MRI and X-ray scanning sessions (within the same study visit). Overall study duration: 2 years (including recruitment, imaging, and data analysis).

Study Arms (2)

MRI in Knee Hemophilic Arthopathy

Participants diagnosed with hemophilia and clinical suspicion of knee arthropathy will undergo magnetic resonance imaging (MRI) of the affected knee. MRI will be performed using standardized sequences to evaluate joint changes, including synovial hypertrophy, hemosiderin deposition, cartilage thinning, and bone damage. Findings will be scored using the International Prophylaxis Study Group (IPSG) MRI scoring system.

Xray in Knee Hemophilic Arthropathy

Participants diagnosed with hemophilia and clinical suspicion of knee arthropathy will undergo conventional radiography (X-ray) of the affected knee. Standard anteroposterior and lateral views will be obtained to evaluate joint changes, including joint space narrowing, osteoporosis, subchondral cysts, erosions, and bone deformities. Findings will be scored using the Pettersson X-ray scoring system.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will include patients diagnosed with hemophilia A or hemophilia B who are at risk of, or clinically suspected to have, hemophilic arthropathy of the knee joint. Participants will be recruited from hematology and orthopedic clinics. Eligible participants will undergo knee MRI to assess for: Synovial abnormalities (e.g., hypertrophy, hemosiderin deposition) Cartilaginous changes (thinning, erosions) Osseous changes (subchondral cysts, bone erosions, marrow changes) Intra-articular bleeding MRI scoring systems will be applied to quantify disease severity and to evaluate the role of MRI as a tool for supporting therapeutic decisions and monitoring treatment response.

You may qualify if:

  • Adult patient ( more than 18 years old ) diagnosed as Haemophilia with history of bleeding in knee joint more than once

You may not qualify if:

  • \*contraindications for MRI such as claustrophobia , metallic foriegn body carriers , cardiac pacemaker
  • patient refused the exam
  • Pregnant female patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Ibad HA, de Cesar Netto C, Shakoor D, Sisniega A, Liu SZ, Siewerdsen JH, Carrino JA, Zbijewski W, Demehri S. Computed Tomography: State-of-the-Art Advancements in Musculoskeletal Imaging. Invest Radiol. 2023 Jan 1;58(1):99-110. doi: 10.1097/RLI.0000000000000908. Epub 2022 Aug 16.

  • Foppen W, van der Schaaf IC, Beek FJA, Mali WPTM, Fischer K. MRI predicts 5-year joint bleeding and development of arthropathy on radiographs in hemophilia. Blood Adv. 2020 Jan 14;4(1):113-121. doi: 10.1182/bloodadvances.2019001238.

  • Lundin B, Manco-Johnson ML, Ignas DM, Moineddin R, Blanchette VS, Dunn AL, Gibikote SV, Keshava SN, Ljung R, Manco-Johnson MJ, Miller SF, Rivard GE, Doria AS; International Prophylaxis Study Group. An MRI scale for assessment of haemophilic arthropathy from the International Prophylaxis Study Group. Haemophilia. 2012 Nov;18(6):962-70. doi: 10.1111/j.1365-2516.2012.02883.x. Epub 2012 Jul 5.

  • Haacke EM, Mittal S, Wu Z, Neelavalli J, Cheng YC. Susceptibility-weighted imaging: technical aspects and clinical applications, part 1. AJNR Am J Neuroradiol. 2009 Jan;30(1):19-30. doi: 10.3174/ajnr.A1400. Epub 2008 Nov 27.

  • Kim HK, Zbojniewicz AM, Merrow AC, Cheon JE, Kim IO, Emery KH. MR findings of synovial disease in children and young adults: Part 1. Pediatr Radiol. 2011 Apr;41(4):495-511; quiz 545-6. doi: 10.1007/s00247-011-1971-0. Epub 2011 Feb 22.

MeSH Terms

Conditions

Hemophilia A

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

kerolos wagdy maurice morid, principal investigator

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 19, 2025

First Posted

November 18, 2025

Study Start

December 1, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

November 18, 2025

Record last verified: 2025-11