A randomized control study to compare functional outcomes between conventional vs newer technique using dHUC in flexor tendon injuries of the hand

Research hypothesis

We hypothesize that in adult patients undergoing surgical repair for flexor tendon injuries of the hand, the newer technique with sterile dehydrated human umbilical cord- derived membrane (dHUC) is associated with significantly improved functional outcomes and enhanced tendon healing compared to conventional repair techniques.

Null hypothesis

We hypothesize that in adult patients undergoing surgical repair for flexor tendon injuries of the hand, the newer technique with sterile dehydrated human umbilical cord- derived membrane (dHUC) does not significantly improve functional outcomes compared to conventional repair techniques

Aim

This study aims to evaluate the effectiveness of newer technique with dehydrated umbilical cord compared to conventional tendon repair in improving the functional outcomes in adult patients with flexor tendon injuries of the hand.

Primary objective

To assess the functional outcomes of application of d-HUC and conventional repair vs conventional repair in flexor tendon injuries of the hand at 3 months and 6 months post-repair

Secondary objectives

1 Incidence of surgical site infection up to 1-month post-surgery.

2  Evaluation of overall hand function and disability using patient-reported outcomes using the Quick Disabilities of the Arm, Shoulder, and Hand (Quick DASH) questionnaire for overall hand function and disability at 3 and 6 months after surgery.

3 Assessment of grip test using Jamar gauge at 3- and 6-months post-surgery.

4  Loss of working days post injury (days away from work) at the end of 6 months.

5 Disability evaluation of the upper limb in accordance with The Gazette of India issued by the Ministry of Social Justice and Empowerment in the year 2024 at 6 months post repair.

Expected outcome

1 Reduced inflammation and adhesions with improved tendon gliding

2 Improved functional outcome post-flexor tendon injury repair

3 Early return to work

Novelty Statement:

Paucity of literature on the usage of dehydrated umbilical cord derivative membrane in flexor tendon injury of the hand

Unlike traditional repair techniques that rely solely on mechanical strength and are often complicated by postoperative adhesions and restricted motion, the dHUC membrane offers several innovative advantages which include physical

barrier to adhesion formation, rich array of growth factors, cytokines, hyaluronic acid, and extracellular matrix proteins, which facilitate cellular proliferation, angiogenesis, and may enhance tissue remodelling at the repair site.

Rationale of the study

Given the tendons complex architecture, vital function in the hand, and high risk of postoperative sequelae such adhesion development and reduced tendon gliding, flexor tendon injuries pose a substantial challenge to hand surgeons. Achieving the best possible functional results is still challenging, even with advancements in surgical procedures and postoperative rehabilitation. The

key objective of traditional repair techniques is to mechanically restore tendon continuity. They frequently overlook the biological context necessary for the best possible healing, though. Fibroblastic activity usually impedes the healing process by causing peritendinous adhesions that restrict range of motion and functional recovery.Biologic scaffolds are new tissue engineering

advancements that may be used as tendons’ repair adjuncts. Sterile dehydrated human umbilical cord-derived membrane (dHUC), which is abundant in growth factors, anti-inflammatory cytokines, and extracellular matrix components, is one such substance. These characteristics could enhance clinical results by minimizing adhesion formation, promoting regenerative repair, and lowering inflammation. The effectiveness of dHUC in treating flexor tendon injuries is yet unknown, despite research showing encouraging outcomes in various orthopedic and soft tissue applications .In order to produce high-quality evidence about its usefulness, safety, and cost- effectiveness in comparison to conventional surgical repair, a thorough evaluation in a double-blinded randomized controlled trial(RCT) setting is necessary.