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IRCT20251202068189N1 IRCT 2026-01-28 Tehran University of Medical Sciences Effect of Hyaluronic Acid on stiffness of wrist Evaluation of the Effect of Intra-Articular Hyaluronic Acid Injection on Postoperative Stiffness in Patients with Distal Radius Fractures Treated with Volar Plate Fixation (ORIF): A Randomized Clinical Trial 2025-12-22 anticipated 60 Complete https://irct.ir/trial/87854 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Eligible patients, after providing informed consent, are randomly assigned to the intervention or control groups using block randomization with a 1:1 allocation ratio. The unit of randomization is the individual patient, and no stratified randomization is applied. The random sequence is generated using statistical software based on blocks of variable size to minimize predictability of group assignment. Allocation concealment is ensured by using sequentially numbered, opaque, sealed envelopes containing the group allocation codes, which are opened only after completion of surgery and wound closure, thereby minimizing selection bias, Blinding description: In this study, participants (patients) are blinded to their group allocation. Outcome assessors, including physiotherapists and personnel responsible for measuring range of motion, pain scores, and functional outcomes, are blinded to group assignment. The statistical analyst performs data analysis using anonymized group codes and is not aware of the treatment allocation. Due to the nature of the intervention, the operating surgeon is aware of the group assignment at the time of intervention; however, the surgeon has no role in outcome assessment, data collection, or statistical analysis. All participants are fully informed about their participation in the study, and written informed consent is obtained; lack of patient awareness of study participation is not involved. 3 Postoperative joint stiffness, distal radius fracture, limitation of wrist range of motion. Intervention 1: Intervention group: Intervention Group (HA group): Patients will receive a single 2 mL intra-articular injection of hyaluronic acid (e.g., sodium hyaluronate 20 mg/2 mL) after wound closure. Intervention 2: Control Group: Patients will receive no injection and standard postoperative care. Yes - There is a plan to make this available What will be shared: Title of shared documents: De-identified raw dataset of primary and secondary outcome measures. Details: Individual participant data will be shared only after complete removal of all identifiable information (including names, national identification numbers, and hospital record numbers). The shared dataset will include wrist range-of-motion measurements, pain scores, functional questionnaire results, and postoperative complication records. Data will be provided exclusively in a fully de-identified format and only for research purposes, upon formal request and approval by the ethics committee When: Access to the shared dataset will begin six months after publication of the final study results and will remain available for at least three years thereafter To whom: Requests for access to the study data may be submitted only by researchers and academic investigators affiliated with recognized universities or research institutions. Applicants must present a clearly defined scientific purpose and obtain ethics committee approval. Data will not be shared with individuals or organizations seeking access for commercial or industrial purposes Conditions: Access to de-identified data will be granted only if the applicant provides a defined research proposal, clear scientific objectives, and an appropriate analysis plan. Use of the data is restricted to academic and statistical research purposes only. Commercial use, promotional use, or redistribution of the dataset is strictly prohibited. Applicants must sign a confidentiality agreement and are permitted to use the dataset solely within the scope of the ethics-approved research protocol. Further sharing of the dataset with third parties without written permission is not allowed Where to obtain: Applicants who wish to obtain the study data or related documentation may submit their official request primarily via email, followed by telephone contact if needed. The designated contact person for responding to data requests is Dr. Ebrahim Khazaee. Email addresses for correspondence: E-khazaee@student.tums.ac.ir khazaei70@yahoo.com Telephone number: +989156210690 If in-person or postal correspondence becomes necessary, arrangements will be made through the above email addresses and the postal address will be provided accordingly. Applicants must submit a clear research objective and a relevant study proposal along with their request How to obtain: The process for obtaining the requested dataset consists of several steps. Applicants must first submit an official request via email, including their research objective and study proposal. The request will be reviewed within 7–14 business days, and additional clarification may be requested if needed. Following initial approval, the request will be evaluated for ethical compliance, which typically requires 14–30 business days. After final approval, the de-identified dataset will be provided within 14 business days through a secure email or restricted access link. Overall, the estimated time required to receive the dataset ranges from 4 to 8 weeks, depending on administrative processing time and applicant responsiveness Comments:
public Ibrahim Alkhuzaie
No.239, between Gisha St. 36 and 38
Tehran Iran (Islamic Republic of) 1448933137 +98 915 621 0690 khazaei70@yahoo.com Tehran University of Medical Sciences scientific Omid Salkhori
Imam Khomeini Hospital Complex, Keshavarz Boulevard, Chamran Highway, Tehran, Iran
Tehran Iran (Islamic Republic of) ۱۴۱۹۷۳۳۱۴۱ +98 922 483 8234 omidsalkhorii303@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Adults aged 18 to 70 years Acute, closed distal radius fracture requiring ORIF with volar plate Ability and willingness to provide written informed consent and adhere to the follow-up schedule 18 years 70 years Both Open or pathological fractures Previous surgery or trauma to the affected wrist Systemic inflammatory joint disease (e.g., rheumatoid arthritis) Known allergy to Hyaluronic Acid or its components Local or systemic infection Inability to participate in rehabilitation or follow-up Intraarticular fracture M25.63 Stiffness of wrist, not elsewhere classified Other Other Intervention group: Intervention Group (HA group): Patients will receive a single 2 mL intra-articular injection of hyaluronic acid (e.g., sodium hyaluronate 20 mg/2 mL) after wound closure. Control Group: Patients will receive no injection and standard postoperative care. Wrist range of motion (flexion–extension), measured using a goniometer by a blinded assessor at 12 weeks post-operation. Timepoint: Wrist flexion–extension ROM will be measured at week 6 and at week 12 after surgery. Method of measurement: Wrist joint range of motion will be measured using a standard goniometer by a trained and blinded assessor. Pain intensity measured using the Visual Analogue Scale by a blinded assessor at weeks two, six, and twelve after surgery. Timepoint: Pain intensity measured at weeks two, six, and twelve after surgery. Method of measurement: Visual Analogue Scale by a blinded assessor. Wrist functional status measured using the Quick Disabilities of the Arm, Shoulder and Hand questionnaire at weeks six and twelve after surgery. Timepoint: at weeks six and twelve after surgery. Method of measurement: the Quick Disabilities of the Arm, Shoulder and Hand questionnaire at weeks six and twelve after surgery. Postoperative complications including persistent joint stiffness, joint swelling, and infection assessed up to week twelve after surgery. Timepoint: up to week twelve after surgery. Method of measurement: Postoperative complications including persistent joint stiffness, joint swelling, and infection will be assessed through clinical examination by the treating physician and documented using a standard clinical evaluation checklist. Tehran University of Medical Sciences Approved 2025-09-30 Ethics Committee of Imam Khomeini Hospital Complex – Tehran University of Medical Sciences Imam Khomeini Hospital Complex, Keshavarz Boulevard, Chamran Highway, Tehran, Iran tehran Tehran Iran (Islamic Republic of)