In this study the primary objective is to measure the complication rate after open or after arthroscopic arthrodesis of the subtalar joint. Secondary outcome measures comprise pain, function and patient satisfaction.
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the early complication rate after surgery. These
early complications consist of wound healing disturbance caused by necrosis of
the skin, superficial wound infection, deep wound infection, nerve damage
caused by the skin incision, and tendon lacerations caused by the skin
incision.
Secondary outcome
Secondary study parameters are the number of late complications (>=6 weeks),
patient satisfaction, pain and function after arthrodesis. Apart from number of
late complications, these parameters will be measured: preoperatively
(excluding satisfaction), and after 3,6,12 months after surgery.
Background summary
Open subtalar arthrodesis is a reliable surgical technique to treat painful
osteoarthritis of the subtalar joint when conservative treatment is not
successful. The arthroscopic technique was introduced to reduce complications
and increase healing rate after subtalar arthrodesis. Many retrospective
studies have described good results after open subtalar arthrodesis and various
prospective studies have described excellent results after arthroscopic
subtalar arthrodesis. However, a prospective randomized study to compare the
two techniques has to the best of our knowledge not been performed.
Study objective
In this study the primary objective is to measure the complication rate after
open or after arthroscopic arthrodesis of the subtalar joint. Secondary outcome
measures comprise pain, function and patient satisfaction.
Study design
The study is an open randomized, prospective, one year follow-up trial.
Patients are randomly allocated to one of the two treatment groups (open or
closed surgery). Due to the nature of the surgery both the subjects and the
orthopedic surgeons cannot be blinded.
Measurement points (coinciding with regular practice) are: preoperative, and
after 3,6,12 months.
Intervention
Open arthrodesis
Open arthrodesis is a surgical procedure of the foot where an incision is made
on the lateral side of the foot to gain access to the subtalar joint. The
cartilage is removed as well as a layer of 2 mm of subchondral bone in order to
create a decorticated, bleeding surface. Two 7.3 mm screws are inserted to
compress the bone of the talus and the calcaneus so consolidation can occur.
Arthroscopic arthrodesis
The arthroscopic technique uses two or three stab incisions around the
hindfoot. Similar to the open technique, a decorticated surface is created
after which the bone is compressed with 7.3 mm screws.
Study burden and risks
For the patients who will be selected from the waiting list at St.
Maartenskliniek Nijmegen and already had a pre-operative visit an additional
baseline visit will be planned to sign informed consent and fill in
questionnaires. In Nijmegen, the post-op visit at 12 months is not part of
standard care and is therefore extra for the study. In Nijmegen the total
amount of extra time that patients spend on this study is 3.5 hours.
The risks associated with the open and arthroscopic techniques are not
different from when the patients do not participate in the study.
Hengstdal 3
Ubbergen 6574 NA
NL
Hengstdal 3
Ubbergen 6574 NA
NL
Listed location countries
Age
Inclusion criteria
1. Isolated subtalar osteoarthritis
2. Diagnosis primary osteoarthritis or posttraumic osteoarthritis
3. 6 Months duration of symptoms
4. Age 18-80y
5. Less than 15 degrees valgus or 5 degrees varus of the subtalar joint
Exclusion criteria
1. Previous surgery of the subtalar joint
2. Osteonecrosis.
3. Rheumatoid arthritis, Complex Regional Pain Syndrom, neurological impairment
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 | NL44790.048.13 |