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 motion2. To evaluate the effect of perioperative micronised…
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
- Soft tissue therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
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.
• During the 6 months postoperative period
- Postoperative complications, including infection, wound-related problems,
malunion/arthritis, non-union 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.
Background summary
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.
Study objective
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
Study burden and risks
1. In case of ORIF, no additional procedures are added to the usual care.
In case of perioperative lipofilling, a minimal amount of autologous fat will
be manually harvested perioperatively from the subdermal fat layer of the lower
abdomen using very fine harvesting cannulas under additional tumescent
anesthesia. The harvested autologous fat will be processed for injection by
centrifugation and emulsification. The harvested and micronized autologous fat
will be injected subcutaneous at the operation site after wound closure.
With regard to the control group, autologous fat of the lower abdomen will be
harvested, but only 0,9% NaCl will be injected subcutaneous at the operation
site after wound closure.
In addition to the regular postoperative follow-up including competent hand
therapy, patients will complete the MHQ and rate their pain using a NRS-score
(0-10 scale) of the abdominal donor site.
2. In case of tenolysis, patients will preoperatively complete the MHQ in
addition to the usual care. The duration of this questionnaire is estimated at
15-30 minutes.
In case of perioperative lipofilling, a minimal amount of autologous fat will
be manually harvested perioperatively from the subdermal fat layer of the lower
abdomen using very fine harvesting cannulas under additional tumescent
anesthesia. The harvested autologous fat will be processed for injection by
centrifugation and emulsification. The harvested and micronized autologous fat
will be injected subcutaneous at the operation site after wound closure.
With regard to the control group, autologous fat of the lower abdomen will be
harvested, but only 0,9% NaCl will be injected subcutaneous at the operation
site after wound closure.
In addition to the regular postoperative follow-up including competent hand
therapy, patients will complete the MHQ and rate their pain using a NRS-score
(0-10 scale) of the abdominal donor site.
Lipofilling is generally considered safe; however, like any surgical
intervention, minor complications can occur with a low rate. Fortunately, the
complication rate with lipofilling is extremely low when compared to most open
surgical methods. Moreover, the likelihood of complications decreases
significantly with the surgeon*s experience.
Henri Dunantstraat 1
's Hertogenbosch 5223
NL
Henri Dunantstraat 1
's Hertogenbosch 5223
NL
Listed location countries
Age
Inclusion criteria
• Aged 16-65 years
• Indication for one of the following surgical procedures:
o ORIF due to a single radiologically proven P1 fracture
o 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 16 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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL85336.028.24 |