Lipofilling in Operative Hand Fracture Treatment
Perioperative Lipofilling in Operative Treatment of Proximal Phalanx Fractures and Related Tenolysis: Improving Range of Motion
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:
- To evaluate the effect of perioperative micronised lipofilling in patients with ORIF of P1 fractures on postoperative range of motion.
- To evaluate the effect of perioperative micronised lipofilling in patients with tenolysis after operative treatment of P1 fractures on postoperative range of motion.
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
- 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Bart C.J.M. de Vries, M.D.
- Phone Number: +31617005068
- Email: bar.d.vries@jbz.nl
Study Locations
-
-
North Brabant
-
's-Hertogenbosch, North Brabant, Netherlands, 5223 GZ
- Jeroen Bosch Ziekenhuis
-
Principal Investigator:
- Brigitte E.P.A. van der Heijden, M.Sc., M.D. Ph.D.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Lipofilling
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.
|
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.
|
|
Placebo Comparator: NaCl
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total Active Motion (TAM)
Time Frame: From enrollment to the end of treatment at 6 months
|
|
From enrollment to the end of treatment at 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
AROM of MCP-, PIP- and DIP-joint
Time Frame: From enrollment to the end of treatment at 6 months
|
Unit of Measure: Degrees (°) |
From enrollment to the end of treatment at 6 months
|
|
PROM of MCP-, PIP- and DIP-joint
Time Frame: From enrollment to the end of treatment at 6 months
|
Unit of Measure: Degrees (°) |
From enrollment to the end of treatment at 6 months
|
|
NRS-score of the abdominal donor site
Time Frame: From 2 weeks postoperative to the end of treatment at 6 months
|
Unit of Measure: Points on a 0-10 scale. |
From 2 weeks postoperative to the end of treatment at 6 months
|
|
Michigan Hand Outcome Questionnaire (MHQ)-score
Time Frame: From enrollment to the end of treatment at 6 months
|
Unit of Measure: Points on a 0-100 scale. |
From enrollment to the end of treatment at 6 months
|
|
Radiographic union
Time Frame: 6 months postoperative
|
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. |
6 months postoperative
|
|
Postoperative complications (and related secondary procedures)
Time Frame: From enrollment to the end of treatment at 6 months
|
|
From enrollment to the end of treatment at 6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Brigitte E.P.A. van der Heijden, M.Sc., M.D. Ph.D., Jeroen Bosch Ziekenhuis
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024.05.25.01
- IIRR-02040 (Other Identifier: Arthrex GmbH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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