To study the radiological and clinical long term results as well as the survival rate in participants of our randomized controlled trial comparing opening- and closing-wedge osteotomy ten and fifteen year post-operatively.
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Functional outcomes: change in severity of pain (Visual Analogue Scale; VAS),
the intermittent and constant pain score; ICOAP, Knee injury and Osteoarthritis
Outcome Score (KOOS), Hospital for Special Surgery scale (HSS)
Secondary outcome
1. Complications and re-operations
2. Medial and lateral collateral ligamentous stability
3. Loss of correction measured with hip-knee-ankle- angle (HKA-angle)
4. Radiological progression of osteoarthritis
5. Patient satisfaction
Background summary
We conducted a RCT in which we compared closing-wedge vs opening-wedge high
tibial osteotomy (HTO). (MEC 196.813/2000/232)
There is a lack of radiological and clinical long term results of well designed
prospective studies comparing closing-wedge and opening-wedge HTO. To study the
results of these techniques on the long term, we aim to re-examine the
participants of this RCT ten and fifteen year postoperatively.
Study objective
To study the radiological and clinical long term results as well as the
survival rate in participants of our randomized controlled trial comparing
opening- and closing-wedge osteotomy ten and fifteen year post-operatively.
Study design
Long-term follow-up of a Randomized Controlled Trial comparing closing-wedge
HTO and opening wedge HTO with identical postoperative care. Closing-wedge HTO
was fixed with staples and opening-wedge HTO with a Puddu-plate.
Patients who underwent total knee arthroplasty (TKA) during follow-up will be
asked to give permission to review their last pre-TKA radiographs.
Patients who did not undergo TKA will be asked to fill in 3 questionnaires
(general questionnaire, Knee Osteoarthritis Outcome Score, Visual Analogue
Score-pain and Intemittent and Constant Pain Score), to visit the department of
Orthopaedics for physical examination and three radiographs will be made; whole
leg radiograph, lateral and posteroanterior view of the knee.
Intervention
Index group: opening wedge osteotomy
Control group: closing wedge osteotomy
Study burden and risks
The burden is primarily time (outpatient clinic visit and questionnaires) and
radiation (three radiographs; whole leg radiograph, lateral and posteroanterior
view of the knee). There is no direct benefit from participation. Travel
allowance will be offered to participants.
's Gravendijkwal 230
Rotterdam 3015 CE
NL
's Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
All patients included in our Randomized Controlled Trial between January 2001 and January 2004.
Exclusion criteria
None
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 | NL42516.078.12 |