Lipofilling in Operative Hand Fracture Treatment

NCT07815444 | Not Yet Recruiting DMC

• 2 other identifiers: 2024.05.25.01IIRR-02040
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Hand fractures are a common clinical problem worldwide and account for a substantial economic burden and workload for experienced hand surgeons. With regard to metacarpal and phalangeal fractures, surgery might be indicated in case of dislocation and/or instability to restore functionality through closed or open reduction and adequate stabilization by fixation. Unfortunately, tendon adhesions after operative treatment of these hand fractures remain a common complication; especially after open reposition and internal fixation (ORIF) of proximal phalanx (P1) fractures. This results in postoperative stiffness and thus decreased digital function. In case of insufficient digital function, tenolysis of the flexor and/or extensor tendons could be considered once the fracture is consolidated and competent hand therapy for at least 3 months seems ineffective. Several studies have focused on perioperative measures to prevent tendon adhesions and related stiffness after operative treatment of hand fractures avoiding tenolysis. These prophylactic measures include for example adhesion barriers, anti-adhesion membranes and adipofascial flaps, which could possibly improve the postoperative range of motion if further research is conducted. Only one of these studies, using an adipofascial flap as a tendon-gliding system after ORIF of P1 fractures, found a significant difference regarding postoperative range of motion. Related to the use of adipose tissue, lipofilling has been proven to be a promising technique in the treatment of scars/adhesions, especially in burn wounds. Recent studies even demonstrated the role of fat grafting in hand surgery, including scar management and tenolysis. Despite these promising results, no previous research has evaluated the use of perioperative lipofilling during surgical treatment of hand fractures or related tenolysis. Therefore, it might be that lipofilling could result in an improvement of postoperative motion and prevent and/or improve tenolysis due to providing a gliding surface for tendons. Aim: The aim of the two separate studies is as follows:

• Total active motion (TAM) of the contralateral unaffected digit. \* 6 weeks, 3 months and 6 months postoperative
• TAM of the operated digit and the contralateral unaffected digit.
• In case of tenolysis after operative treatment of P1 fractures the following parameters will be assessed:
• Preoperative \- TAM of the affected digit and the contralateral unaffected digit.
• 6 weeks, 3 months and 6 months postoperative
• TAM of the operated digit and the contralateral unaffected digit. Secondary outcome measures:
• In case of an indication for ORIF of P1 fractures the following parameters will be assessed:
• Preoperative \- Active range of motion (AROM) and passive range of motion (PROM) of the metacarpophalangeal, proximal interphalangeal and distal interphalangeal (MCP-, PIP- and DIP) joint of the contralateral unaffected digit.
• 2 weeks, 6 weeks, 3 months and 6 months postoperative \- NRS-score of the abdominal donor site.
• 6 weeks, 3 months and 6 months postoperative
• AROM and PROM of the MCP-, PIP- and DIP-joint of the operated digit and the contralateral unaffected digit;
• MHQ-score.
• 6 months postoperative \- Radiographic union of the operated digit.
• During the 6 months postoperative period
• Postoperative complications, including infection, wound-related problems, and stiffness;
• Number of secondary procedures, including tenolysis.
• In case of tenolysis after operative treatment of P1 fractures the following parameters will be assessed:
• Preoperative
• AROM and PROM of the MCP-, PIP- and DIP-joint of the affected digit and the contralateral unaffected digit;
• MHQ-score.
• 2 weeks, 6 weeks, 3 months and 6 months postoperative \- NRS-score of the abdominal donor site.
• 6 weeks, 3 months and 6 months postoperative
• AROM and PROM of the MCP-, PIP- and DIP-joint of the operated digit and the contralateral unaffected digit;
• MHQ-score.
• During the 6 months postoperative period - Postoperative complications, including infection, wound-related problems and stiffness.

Conditions

Adhesions; Hand Fractures; Tenolysis

Keywords

hand; fracture; surgery; operative treatment; adhesion; tenolysis; lipofilling; fat grafting

Outcome Measures

Primary Outcomes (1)

• Total Active Motion (TAM)

  1. In case of an indication for ORIF of P1 fractures the following parameters will be assessed: \* Preoperative * Total active motion (TAM) of the contralateral unaffected digit. \* 6 weeks, 3 months and 6 months postoperative * TAM of the operated digit and the contralateral unaffected digit. 2. In case of tenolysis after operative treatment of P1 fractures the following parameters will be assessed: * Preoperative \- TAM of the affected digit and the contralateral unaffected digit. * 6 weeks, 3 months and 6 months postoperative * TAM of the operated digit and the contralateral unaffected digit.

  From enrollment to the end of treatment at 6 months

Secondary Outcomes (6)

• AROM of MCP-, PIP- and DIP-joint

  From enrollment to the end of treatment at 6 months

• PROM of MCP-, PIP- and DIP-joint

  From enrollment to the end of treatment at 6 months

• NRS-score of the abdominal donor site

  From 2 weeks postoperative to the end of treatment at 6 months

• Michigan Hand Outcome Questionnaire (MHQ)-score

  From enrollment to the end of treatment at 6 months

• Radiographic union

  6 months postoperative

Study Arms (2)

Lipofilling

EXPERIMENTAL

Perioperatively, 20ml of lipoaspirate will be manually harvested, under additional tumescent anesthesia of an area with a diameter of ca. 15cm, from the subdermal fat layer of the lower abdomen using Arthrex ACP double syringes (Arthrex®, ACP System, Naples, FL, USA) and disposable instruments of the Arthrex ACA-kit. After harvesting, the lipoaspirate will be centrifuged (Hettich centrifuge (1206-ART)) at a G-force of 960G, emulsified by using a connector piece between two luerlock syringes and centrifuged again, after being transferred back in to the Arthrex ACP double syringe, to process the micronized autologous fat for injection. In case of lipofilling, 1ml of the harvested and micronized autologous fat will be injected subcutaneous at the operation site after wound closure.

Procedure: Lipofilling in Operative Treatment of Proximal Phalanx Fractures and Related Tenolysis

NaCl

PLACEBO COMPARATOR

Perioperatively, 20ml of lipoaspirate will be manually harvested, under additional tumescent anesthesia of an area with a diameter of ca. 15cm, from the subdermal fat layer of the lower abdomen using Arthrex ACP double syringes (Arthrex®, ACP System, Naples, FL, USA) and disposable instruments of the Arthrex ACA-kit. After harvesting, the lipoaspirate will be centrifuged (Hettich centrifuge (1206-ART)) at a G-force of 960G, emulsified by using a connector piece between two luerlock syringes and centrifuged again, after being transferred back in to the Arthrex ACP double syringe, to process the micronized autologous fat for injection. In case of the control group, 1ml of 0,9% NaCl will be injected subcutaneous at the operation site after wound closure.

Procedure: Lipofilling in Operative Treatment of Proximal Phalanx Fractures and Related Tenolysis

Interventions

Lipofilling in Operative Treatment of Proximal Phalanx Fractures and Related Tenolysis PROCEDURE

Perioperatively, 20ml of lipoaspirate will be manually harvested, under additional tumescent anesthesia of an area with a diameter of ca. 15cm, from the subdermal fat layer of the lower abdomen using Arthrex ACP double syringes and disposable instruments of the Arthrex ACA-kit. After harvesting, the lipoaspirate will be centrifuged at a G-force of 960G, emulsified by using a connector piece between two luerlock syringes and centrifuged again, after being transferred back in to the Arthrex ACP double syringe, to process the micronized autologous fat for injection. In case of lipofilling, 1ml of the harvested and micronized autologous fat will be injected subcutaneous at the operation site after wound closure. The amount of micronized autologous fat is based on the expected available subcutaneous space after closing the wound. With regard to the control group, only 1ml of 0,9% NaCl will be injected subcutaneous at at the operation site after wound closure.

Lipofilling; NaCl

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-65 years
• Indication for one of the following surgical procedures:
• ORIF due to a single radiologically proven P1 fracture
• Secondary tenolysis due to limited digital function after former operative treatment of a P1 fracture
• Able to read and speak Dutch
• Mentally competent

You may not qualify if:

• Aged below 18 or above 65 years
• Concomitant tendinous or neurovascular injuries
• Prior surgical interventions of the affected digit; other than operative fracture fixation in case of tenolysis
• Prior pathology or surgical interventions of the contralateral digit
• Less than 3 months of competent hand therapy in case of secondary tenolysis
• A known psychiatric condition
• A known systemic disease that will impair wound healing (e.g. diabetes mellitus, known atherosclerosis with an event that required hospitalization, collagen diseases, diseases of the skin, HIV).
• Prednisone or other immunotherapy
• Smoking
• Pregnancy or active child wish

Sponsors & Collaborators

• Jeroen Bosch Ziekenhuis: lead
• Arthrex GmbH: collaborator

Study Sites (1)

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, North Brabant, 5223 GZ, Netherlands

Location

MeSH Terms

Conditions

Tissue Adhesions; Fractures, Bone

Condition Hierarchy (Ancestors)

Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Study Officials

• Brigitte E.P.A. van der Heijden, M.Sc., M.D. Ph.D.

  Jeroen Bosch Ziekenhuis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bart C.J.M. de Vries, M.D.

CONTACT

+31617005068; bar.d.vries@jbz.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2026
• First Posted: September 11, 2026
• Study Start (Estimated): October 19, 2026
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): July 1, 2030
• Last Updated: September 11, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)