Protection of Knee Joints in Bleeding Disorder Patients

NCT06039904 | Completed DMC

• 1 other identifier: COA.MURA2021/292
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

INTRODUCTION Knee supports, usually made with sponge cushion, are used to protect knee joint and prevent its injury. Sponge has less elasticity and durability compared with natural rubber. To our knowledge, there has been no study regarding effectiveness of natural rubber and sponge for knee joint protection and injury prevention in children with bleeding disorders. AIMS The study aimed to compare the effectiveness and satisfaction between natural rubber and sponge knee supports for knee joint protection among children with bleeding disorders METHODS The study had three phases: 1) measurement of compression force, 2) fabrication of knee supports, and 3) a randomized crossover trial. The supports were fabricated in 4 sizes, S, M, L, and XL. They comprised two parts: body, made from stretchable cotton; and cushion (protection part), made from either natural rubber or sponge. The trial included 8 weeks of alternatively wearing natural rubber knee support and sponge knee support with a 4-week wash-out period. Numbers of knee bleeds and satisfied users were recorded.

Conditions

Bleeding Disorder; Knee Injuries; Hemophilia

Outcome Measures

Primary Outcomes (1)

• Number of knee bleeding

  Number of intra and extraarticular knee bleedings

  8 weeks

Study Arms (2)

Arm A

EXPERIMENTAL

Arm A was first assigned to Treatment I of natural rubber knee support followed by Treatment II of sponge knee support

Device: Natural rubber knee support

Arm B

EXPERIMENTAL

Arm B was first assigned to Treatment II of sponge knee support followed by Treatment I of natural rubber knee support

Device: Sponge knee support

Interventions

Natural rubber knee support DEVICE

The knee support comprised two parts, the support body and the protective cushion. Which were categorized into four sizes, S, M, L and XL according to widths and lengths, as follows: size S, 8x17 cm; size M, 10x19 cm; size L, 12x24 cm; and size XL, 14x28 cm. The support body was made of stretchable natural cotton fabrics, which were comfortable, breathable, washable, less irritant and flexible. Similarly, the protective cushion was classified into four sizes: S, M, L and XL with diameters (based on the patellar diameters) of 5, 6, 7 and 8 cm, respectively. Cushions were made from either natural rubber and inserted at the front of the support body (to cover the patellar).

Also known as: Sponge knee support

Arm A

Sponge knee support DEVICE

The knee support comprised two parts, the support body and the protective cushion. Which were categorized into four sizes, S, M, L and XL according to widths and lengths, as follows: size S, 8x17 cm; size M, 10x19 cm; size L, 12x24 cm; and size XL, 14x28 cm. The support body was made of stretchable natural cotton fabrics, which were comfortable, breathable, washable, less irritant and flexible. Similarly, the protective cushion was classified into four sizes: S, M, L and XL with diameters (based on the patellar diameters) of 5, 6, 7 and 8 cm, respectively. Cushions were made from either sponge and inserted at the front of the support body (to cover the patellar).

Arm B

Eligibility Criteria

• Age: 9 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• bleeding disorder patients, aged 9 months to 12 years old, with written consents

You may not qualify if:

• coexisting diseases affecting their activities, or bleeding episodes two weeks before the study

Sponsors & Collaborators

• Ramathibodi Hospital: lead

Study Sites (1)

Supicha Maneekhiew

Bangkok, 10220, Thailand

Location

MeSH Terms

Conditions

Hemostatic Disorders; Knee Injuries; Hemophilia A

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Leg Injuries; Wounds and Injuries; Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Coagulation Protein Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Model Details: Randomized crossover trial

Study Record Dates

• First Submitted: September 9, 2023
• First Posted: September 15, 2023
• Study Start: April 8, 2021
• Primary Completion: April 1, 2022
• Study Completion: September 1, 2022
• Last Updated: September 15, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)