Aim of this prospective randomized trial (RCT) is to compare the gold standard LCW with the CWO in patients eligible for HTO who need a correction of 10 to 16 degrees. Hypothesis is that the CWO technique will achieve more accurate overcorrection of…
ID
Bron
Verkorte titel
Aandoening
Medial compartment osteoarthritis
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Primary outcome measure is achievement of an overcorrection of 4 degrees valgus after one year of surgery (HKA angle).
Achtergrond van het onderzoek
High tibial osteotomy (HTO) is a common procedure to treat symptomatic osteoarthritis of the medial compartment of the knee with varus alignment. This is achieved by overcorrecting the varus alignment to 2-6 degrees of valgus. To achieve this, different HTO techniques are being used. The most common used techniques are medial opening wedge (MOW) and lateral closing wedge (LCW) HTOs. A Cochrane review showed no
evidence whether LCW or MOW is more effective in the treatment of symptomatic medial knee OA, however the LCW is seen as the gold standard. A relatively new technique, the combined valgus producing high tibial osteotomy (CWO), claims to include the advantages of both techniques. This HTO modification avoids metaphyseal tibial bone loss, and decreases the transposition of the tibia condyle and shortening of the patellar tendon after osteotomy even in case of great correction. During the last few years, both the LCW and CWO techniques are commonly used for HTO at the department of Orthopaedics of the Martini Hospital. The clinical results of the CWO technique are very promising. However, until now, there is little scientific evidence on the effectiveness of CWO. Objective of the study: Aim of this prospective randomized trial (RCT) is to compare the gold standard LCW with the CWO in patients eligible for HTO who need a correction of 10 to 16 degrees. Hypothesis is that the CWO technique will achieve more accurate overcorrection of varus malalignment with less anatomical changes of the proximal tibia after 1 year.
Doel van het onderzoek
Aim of this prospective randomized trial (RCT) is to compare the gold standard LCW with the CWO in patients eligible for HTO who need a correction of 10 to 16 degrees. Hypothesis is that the CWO technique will achieve more accurate overcorrection of varus malalignment with less anatomical changes of the proximal tibia after 1 year.
Onderzoeksopzet
Preoperatively and 6 weeks, 6 months and one year postoperatively.
Onderzoeksproduct en/of interventie
Patients will undergo a HTO, with either a LCW technique or a CWO technique.
Publiek
Van Swietenplein 1
M.R. Huizinga
Groningen 9728 NT
The Netherlands
+31 (0)50 5245970
m.r.huizinga@mzh.nl
Wetenschappelijk
Van Swietenplein 1
M.R. Huizinga
Groningen 9728 NT
The Netherlands
+31 (0)50 5245970
m.r.huizinga@mzh.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Radiologically confirmed medial compartment osteoarthritis of the knee;
2. Medial joint pain;
3. Varus alignment between 6-12 degrees;
4. An age of 18 and older.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Symptomatic osteoarthritis of the lateral compartment;
2. Rheumatoid arthritis;
3. Range of motion of the knee joint less than 100 degrees;
4. Flexion contracture more than 10 degrees.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL3735 |
NTR-old | NTR3898 |
Ander register | METC : 43154.099.13 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |