The main purpose of this study is to compare the functional outcome after arthroscopic and open anatomic repair in patients with chronic lateral ankle instability, and secondly assess ankle stability and ankle Range of Motion (ROM) after…
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is a change in FAOS score of 10 points. This is
measured using a questionnaire containing the foot and ankle outcome score
(FAOS), numeratic rating scale (NRS) and Cumberland ankle instability tool
(CAIT). The primary outcome measures are pain, disability and degree of
experienced ankle instability, using. Assessment is performed pre-operatively,
and at 3- and 6-months postoperatively.
Secondary outcome
Secondary study parameters are a negative anterior drawer test and normal ROM.
The anterior drawer test is registered per mm (range 0-15mm) displacement. ROM
is registered in degrees of dorsi- and plantarflexion and is measured using a
goniometer. Assessment is performed pre-operatively, and at 3- and 6-months
postoperatively.
Additionally we measure complications and recurrence of instability.
Background summary
Lateral ankle ligament injuries may be a result of ankle sprains. In 10-30% of
patients with lateral ankle ligament injuries, chronic lateral ankle
instability may be present. If conservative treatment fails, instability is
treated surgically. The Bröstrom-Gould procedure is the current golden standard
for surgical treatment of chronic ankle instability. This technique is
performed both arthroscopically and open. Which approach is better, has not yet
been researched.
Study objective
The main purpose of this study is to compare the functional outcome after
arthroscopic and open anatomic repair in patients with chronic lateral ankle
instability, and secondly assess ankle stability and ankle Range of Motion
(ROM) after arthroscopic and open ligament repair.
Study design
A Non-Blinded Prospective Randomized Controlled Trial
Intervention
Both groups of patients are surgically treated by means of the Bröstrom-Gould
technique. One group is treated by arthroscopic approach and the second group
is treated by the open approach
Study burden and risks
Patient burden is mainly due to extra visits to the outpatient clinic.
Pre-operatively the patient will be asked to fill out a questionnaire, and the
anterior drawer test and ROM will be checked. Post-operatively the patient will
be asked to visit the outpatient clinic 2 more times (3- and 6-months
postoperatively) additional to the regular check-ups.
The risk of the investigational treatment is minimal, due to the fact that both
treatments, open and closed ligament repair, are currently used in clinical
practise and both provide clinically good results. Additional
risks/complications associated with ankle surgery can be bleeding, infection,
venous thrombosis, over- and under correction, instability recurrence, pain,
swelling, reduced ROM and damage to superficial nerves.
Patients may benefit from participation as they are more closely followed-up
over time compared to regular procedures. They will receive a standard
treatment for ankle instability (open or arthroscopic), but will be assessed 2
extra times up till 6 months after surgery. This way it is easier for patients
to indicate (new) complaints and complications.
Patients in the open treatment group might experience more wound complications.
This, however, is not yet proven, as is which technique is superior and
therefor this study will be performed. To study the two different techniques,
their outcomes and complications, to ensure patients will not be unnecessarily
exposed to unwanted or side effects.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
- Patients are 18 years or older;
- Experience pain and/or a sensation of instability during sports and/or daily
activity;
- Isolated lateral ankle instability;
- Planned for surgical repair of the ATFL;
- At least one previous episode of an ankle inversion sprain;
- Complaints for at least 6 months;
- Failed previous conservative treatment
Exclusion criteria
- Serious concomitant injury
- Acute foot or ankle fracture;
- Previous foot or ankle surgery;
- Osteochondral defect (OCD) of the talus with a diameter of >2cm treated
using other techniques than bone marrow stimulation (BMS)
- ROM restriction of >10 graden;
- Medial instability
- Severe misalignment;
- Ankle/foot deformities
- Systemic comorbidity leading to delayed recovery
- (general) Hyperlaxity
- Inability or unwillingness to provide consent
- Present factors that may cause difficulty of follow-up
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 | NL55707.018.16 |