Comparing two method 's of surgical hammer toe correction. Make clear the value of the K-wire.We use questionnaires about function and pain, patient satisfaction, complication registration, position controle of the toe and x-rays to achieve our…
ID
Source
Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
AOFAS (American Orthopaedic Foot and Ankle Society) lesser toe
metatarsophalangeal scale
Secondary outcome
Patient satisfaction (VAS)
Complications (infection, deep venous thrombosis).
Revision surgery.
Postoperative X-ray.
Toe position after one year.
Background summary
For the surgical correction of hammertoes there are several surgical options.
In our clinic, we mostly use the pip joint resection with four weeks of K-wire
fixation. After four weeks the K-wire is removed at the outpatient clinic.
After the removal patients can wear their normal footwear.
There are also variants where no surgical fixation with K-wire is used.
K-wire fixation has several disadvantages:
- Porte d'entrée for infection
- Discomfort to the patient
- Additional costs
- Longer duration of surgery
- Needlestick injury hazard
No fixation of the toe will possibly lead to a position of the toe which is not
as good as the position after K-wire fixation.
So, with this study we want to compare both methods and their advantages and
disadvantages. And make clear the value of the K-wire.
Study objective
Comparing two method 's of surgical hammer toe correction. Make clear the value
of the K-wire.
We use questionnaires about function and pain, patient satisfaction,
complication registration, position controle of the toe and x-rays to achieve
our goal.
Study design
In a prospective randomized controlled trial, we will evaluate pre- en
postoperative (6 weeks and 1 year) function, pain and satisfaction in 23
patients in group A with a fixed hammertoe deformity after surgery with K-wire
fixation and 23 patients in group B without K-wire fixation. Both surgical
techniques are standardized.
Randomization takes place during the surgery at the moment of placing the
K-wire or closing the wound. Using this, we are confident that randomizationhas
no effect on the surgical procedure.
At 2, 4 and 6 weeks and one year after operation we see the patients in the
outpatient clinic:
* week 2 inspection of the wound and record complications,
* week 4 removing K-wire in group A and record complications,
* week 6 X-ray, fill in the AOFAS lesser toe metatarsophalangeal scale and ask
for patient satisfaction,
* one year for examination of the toe position, fill in the AOFAS lesser toe
metatarsophalangeal scale and ask for patient satisfaction.
Surgical technique:
Dorsal incision over the deformed pip joint, cleavage of the extensor tendon,
opening and release of the joint capsule, resection of the distal condyles of
the proximal phalanx, resection of the sharp edges of the bone, wound
irrigation with NaCl, randomization for group A or B.
A. Placement of the K-wire inside out, outside in through the distal, mid and
proximal phalanx.
Position control, if correct close the skin with Donati sutures of monocryl.
B. Wound closure with Donati sutures of monocryl.
Continuous compressive bandage for 7 days, and weight bearing in a special shoe
for 4 weeks .
Intervention
Surgical technique:
Dorsal incision over the deformed pip joint, cleavage of the extensor tendon,
opening and release of the joint capsule, resection of the distal condyles of
the proximal phalanx, resection of the sharp edges of the bone, wound
irrigation with NaCl, randomization for group A or B.
A. Placement of the K-wire inside out, outside in through the distal, mid and
proximal phalanx.
Position control, if properly close the skin with Donati sutures of monocryl.
B. Wound closure with Donati sutures of monocryl.
Continuous compressive bandage for 7 days, and weight bearing in a special shoe
for 4 weeks .
Study burden and risks
There are no other risks or loads, except the three questionnaires and
additional outpatient visit 1 year post-operatively, compared with the patients
who received "normal" treatment.
Dominee Theodor Fliednerstraat 1
Eindhoven 5631 BM
NL
Dominee Theodor Fliednerstraat 1
Eindhoven 5631 BM
NL
Listed location countries
Age
Inclusion criteria
age > 18
Hammer toe 2,3 or 4th toe
One surgical procedure
No other actual foot problems
Exclusion criteria
Age<18
Other footproblems
Other footsurgery during same procedure
Reumatoid arthritis
Insulin dependent diabetes Mellitus
Design
Recruitment
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 | NL47261.015.13 |