An interventional study of Lipofilling in Operative Treatment of Proximal Phalanx Fractures and Related Tenolysis in Adhesions, Hand Fractures and Tenolysis, sponsored by Jeroen Bosch Ziekenhuis. Not yet recruiting at 1 site in Netherlands. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by Jeroen Bosch Ziekenhuis · Not applicable, Interventional, and Treatment
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:
Study design:
A double-blinded randomized controlled trial
Intervention:
Patients will either receive 1ml of subcutaneous micronised lipofilling or 1ml subcutaneous 0,9% NaCl around the operation site at the end of the ORIF or tenolysis.
Primary outcome measures:
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
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
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
6 months postoperative
- Radiographic union of the operated digit.
During the 6 months postoperative period
In case of tenolysis after operative treatment of P1 fractures the following parameters will be assessed:
Preoperative
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
121 studies on the registry are indexed under Tissue Adhesions; 15 are open to participants now.
This study's planned enrollment of 130 is above the median of 61 across 84 interventional studies indexed under Tissue Adhesions.
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Indication for one of the following surgical procedures:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
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HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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.
Time frame: From enrollment to the end of treatment at 6 months
AROM of MCP-, PIP- and DIP-joint
1. In case of an indication for ORIF of P1 fractures the following parameters will be assessed: \* Preoperative * Active range of motion (AROM) of the metacarpophalangeal, proximal interphalangeal and distal interphalangeal (MCP-, PIP- and DIP) joint of the contralateral unaffected digit. \* 6 weeks, 3 months and 6 months postoperative * AROM of the MCP-, PIP- and DIP-joint 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 \- AROM of the MCP-, PIP- and DIP-joint of the affected digit and the contralateral unaffected digit. * 6 weeks, 3 months and 6 months postoperative * AROM of the MCP-, PIP- and DIP-joint of the operated digit and the contralateral unaffected digit. Unit of Measure: Degrees (°)
Time frame: From enrollment to the end of treatment at 6 months
PROM of MCP-, PIP- and DIP-joint
1. In case of an indication for ORIF of P1 fractures the following parameters will be assessed: \* Preoperative * Passive range of motion (PROM) of the metacarpophalangeal, proximal interphalangeal and distal interphalangeal (MCP-, PIP- and DIP) joint of the contralateral unaffected digit. \* 6 weeks, 3 months and 6 months postoperative * PROM of the MCP-, PIP- and DIP-joint 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 \- PROM of the MCP-, PIP- and DIP-joint of the affected digit and the contralateral unaffected digit. * 6 weeks, 3 months and 6 months postoperative * PROM of the MCP-, PIP- and DIP-joint of the operated digit and the contralateral unaffected digit. Unit of Measure: Degrees (°)
Time frame: From enrollment to the end of treatment at 6 months
NRS-score of the abdominal donor site
1. In case of an indication for ORIF of P1 fractures the following parameters will be assessed: \* 2 weeks, 6 weeks, 3 months and 6 months postoperative \- Pain at the abdominal donor site using the Numeric Rating Scale (NRS). Participants will rate their pain intensity on a scale from 0 to 10, where 0 represents no pain and 10 represents the worst imaginable pain. Higher scores indicate greater pain and therefore a worse outcome. 2. In case of tenolysis after operative treatment of P1 fractures the following parameters will be assessed: * 2 weeks, 6 weeks, 3 months and 6 months postoperative * Pain at the abdominal donor site using the Numeric Rating Scale (NRS). Participants will rate their pain intensity on a scale from 0 to 10, where 0 represents no pain and 10 represents the worst imaginable pain. Higher scores indicate greater pain and therefore a worse outcome. Unit of Measure: Points on a 0-10 scale.
Time frame: From 2 weeks postoperative to the end of treatment at 6 months
Michigan Hand Outcome Questionnaire (MHQ)-score
1. In case of an indication for ORIF of P1 fractures the following parameters will be assessed: \* 6 weeks, 3 months and 6 months postoperative \- Hand function and patient-reported outcomes will be assessed using the Michigan Hand Outcomes Questionnaire (MHQ). The overall MHQ score ranges from 0 to 100, with higher scores indicating a better outcome. 2. In case of tenolysis after operative treatment of P1 fractures the following parameters will be assessed: * Preoperative \- Hand function and patient-reported outcomes will be assessed using the Michigan Hand Outcomes Questionnaire (MHQ). The overall MHQ score ranges from 0 to 100, with higher scores indicating a better outcome. * 6 weeks, 3 months and 6 months postoperative * Hand function and patient-reported outcomes will be assessed using the Michigan Hand Outcomes Questionnaire (MHQ). The overall MHQ score ranges from 0 to 100, with higher scores indicating a better outcome. Unit of Measure: Points on a 0-100 scale.
Time frame: From enrollment to the end of treatment at 6 months
Radiographic union
1\. In case of an indication for ORIF of P1 fractures the following parameters will be assessed: \* 6 months postoperative \- Radiographic union of the operated digit.
Time frame: 6 months postoperative
Postoperative complications (and related secondary procedures)
1. In case of an indication for ORIF of P1 fractures the following parameters will be assessed: \* During the 6 months postoperative period * Postoperative complications, including infection, wound-related problems, and stiffness; * Number of secondary procedures, including tenolysis. 2. In case of tenolysis after operative treatment of P1 fractures the following parameters will be assessed: * During the 6 months postoperative period - Postoperative complications, including infection, wound-related problems and stiffness.
Time frame: From enrollment to the end of treatment at 6 months
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Jeroen Bosch Ziekenhuis