AdhesionsNCT07815444
Lipofilling in Operative Hand Fracture Treatment
A study testing Lipofilling in Operative Treatment of Proximal Phalanx Fractures and Related Tenolysis in people with Adhesions and Hand Fractures, run by Jeroen Bosch Ziekenhuis at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Adhesions, Hand Fractures, Tenolysis
- What is being tested?
- Lipofilling in Operative Treatment of Proximal Phalanx Fractures and Related Tenolysis
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 siteNetherlands
- Study dates
- 19 Oct 2026to 1 Jul 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, North Brabant, 5223 GZ
Brigitte E.P.A. van der Heijden, M.Sc., M.D. Ph.D.
About this study
Official title: 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.
Read more
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.
- Conditions
- Adhesions, Hand Fractures, Tenolysis
- Being tested
- Lipofilling in Operative Treatment of Proximal Phalanx Fractures and Related Tenolysis
- Keywords
- hand, fracture, surgery, operative treatment, adhesion, tenolysis, lipofilling, fat grafting
- Medical subject headings
- Tissue Adhesions, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lipofilling in Operative Treatment of Proximal Phalanx Fractures and Related TenolysisProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Lipofilling in Operative Treatment of Proximal Phalanx Fractures and Related Tenolysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Active Motion (TAM)
- 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.
Measured: From enrollment to the end of treatment at 6 months
Secondary outcomes (6)
AROM of MCP-, PIP- and DIP-joint
- 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.
- 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 (°)
Measured: From enrollment to the end of treatment at 6 months
PROM of MCP-, PIP- and DIP-joint
- 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.
- 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 (°)
Measured: From enrollment to the end of treatment at 6 months
NRS-score of the abdominal donor site
- 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.
- 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.
Measured: From 2 weeks postoperative to the end of treatment at 6 months
Michigan Hand Outcome Questionnaire (MHQ)-score
- 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.
- 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.
Measured: From enrollment to the end of treatment at 6 months
Radiographic union
- 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.
Measured: 6 months postoperative
Postoperative complications (and related secondary procedures)
- 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.
- 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.
Measured: From enrollment to the end of treatment at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study start19 Oct 2026 (estimated)
- Primary completion1 Jul 2030 (estimated)
- Study completion1 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdhesionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jeroen Bosch Ziekenhuis
- Sponsor type
- University, hospital or other
- Collaborators
- Arthrex GmbH
- Responsible party
- Sponsor
- Investigators
- Brigitte E.P.A. van der Heijden, M.Sc., M.D. Ph.D., Principal investigator, Jeroen Bosch Ziekenhuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07815444
- Sponsor's protocol ID
- 2024.05.25.01
- Other IDs
- IIRR-02040
- Status last verified
- Aug 2026
- First submitted
- 3 Aug 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Lipofilling in Operative Treatment of Proximal Phalanx Fractures and Related Tenolysis: Improving Range of Motion
- ClinicalTrials.gov ID
- NCT07815444
- Acronym / sponsor ID
- 2024.05.25.01
- Conditions
- Adhesions, Hand Fractures, Tenolysis
- Keywords
- hand, fracture, surgery, operative treatment, adhesion, tenolysis, lipofilling, fat grafting
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Jeroen Bosch ZiekenhuisUniversity, hospital or other
- Collaborators
- Arthrex GmbH
- Study start
- 19 Oct 2026 (estimated)
- Primary completion
- 1 Jul 2030 (estimated)
- Study completion
- 1 Jul 2030 (estimated)
- First posted
- 11 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lipofilling | Experimental | Procedure: Lipofilling in Operative Treatment of Proximal Phalanx Fractures and Related TenolysisPerioperatively, 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. |
| NaCl | Placebo comparator | Procedure: Lipofilling in Operative Treatment of Proximal Phalanx Fractures and Related TenolysisPerioperatively, 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18-65 years
- Indication for one of the following surgical procedures:
- Able to read and speak Dutch
- Mentally competent
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lipofilling in Operative Treatment of Proximal Phalanx Fractures and Related TenolysisPerioperatively, 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. | Procedure or surgery | Lipofilling, NaCl |
Primary outcome
Total Active Motion (TAM)
Time frame: From enrollment to the end of treatment at 6 months
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.
6 secondary outcomes
AROM of MCP-, PIP- and DIP-joint
Time frame: 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
NRS-score of the abdominal donor site
Time frame: 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
Radiographic union
Time frame: 6 months postoperative
Postoperative complications (and related secondary procedures)
Time frame: From enrollment to the end of treatment at 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brigitte E.P.A. van der Heijden, M.Sc., M.D. Ph.D. principal investigator
Jeroen Bosch Ziekenhuis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lipofilling in Operative Treatment of Proximal Phalanx Fractures and Related Tenolysis in people with Adhesions and Hand Fractures, run by Jeroen Bosch Ziekenhuis at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bart C.J.M. de Vries, M.D. (+31617005068, bar.d.vries@jbz.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Active Motion (TAM) (time frame: From enrollment to the end of treatment at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.