Adhesions, Hand Fractures, Tenolysis
Conditions
Keywords
hand, fracture, surgery, operative treatment, adhesion, tenolysis, lipofilling, fat grafting
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: 1. To evaluate the effect of perioperative micronised lipofilling in patients with ORIF of P1 fractures on postoperative range of motion. 2. 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: 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. Secondary outcome measures: 1. 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. 2. 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.
Interventions
PROCEDURELipofilling 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.
Sponsors
Jeroen Bosch Ziekenhuis
Arthrex GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Active Motion (TAM) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AROM of MCP-, PIP- and DIP-joint | 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 * 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 (°) |
| PROM of MCP-, PIP- and DIP-joint | 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 * 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 (°) |
| NRS-score of the abdominal donor site | From 2 weeks postoperative 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: \* 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. |
| Michigan Hand Outcome Questionnaire (MHQ)-score | 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: \* 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. |
| Radiographic union | 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. |
| Postoperative complications (and related secondary procedures) | 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: \* 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. |
Countries
Netherlands
Contacts
CONTACTBart C.J.M. de Vries, M.D.
PRINCIPAL_INVESTIGATORBrigitte E.P.A. van der Heijden, M.Sc., M.D. Ph.D.
Jeroen Bosch Ziekenhuis
Outcome results
None listed