The clinical effect of Knee Joint Distraction (determined by WOMAC) is not (clinically relevant) different from Total Knee Prosthesis at two years post treatment (equivalence hypothesis).
ID
Bron
Aandoening
Osteoarthritis of the knee.
Ondersteuning
Universital Medical Center Utrecht
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Clinical effectiveness determined by WOMAC at two years.
Achtergrond van het onderzoek
This, multi-center, randomised controlled, non-blinded prospective 2 years follow-up trial will be accomplished at the Maartenskliniek Woerden (MK-W) in collaboration with the University Medical Center Utrecht (UMCU). Patients with severe OA of the knee, whom are indicated for a TKP by a orthopaedic surgeon and meet the inclusion criteria are asked to participate. When included, patients will be randomised between TKP en KJD (2:1). Clinical outcome parameters are evaluated over time up to 2 years. Data on direct and indirect costs as well as change in quality of life are gathered by use of questionnaires. Additionally, the KJD patients are monitored for tissue structure repair. Blood and urine will be collected before and up to 2 years after surgery. Samples are used for evaluation of biochemical markers of cartilage and bone synthesis and breakdown. Moreover, at baseline and over time up to 2 years, X-ray and MRI images are evaluated for cartilage and bone changes.
Doel van het onderzoek
The clinical effect of Knee Joint Distraction (determined by WOMAC) is not (clinically relevant) different from Total Knee Prosthesis at two years post treatment (equivalence hypothesis).
Onderzoeksopzet
Baseline (2x), 3 and 6 weeks, 3, 6, 9, 12, 18 and 24 months follow-up.
Onderzoeksproduct en/of interventie
KJD is performed according to the methodology as used in previous knee distraction studies, using 2 monotubes, one laterally and one medially. Intra-operative the tubes are distracted 2 mm. During hospitalization the frame is further distracted, 1mm a day, until in total 5 mm is reached. Distraction lasts for 6 weeks whereby fully load bearing is encouraged, with crutches for stability. After 6 weeks the frame is removed at day-care surgery.
TKP is performed as usual according to the clinical protocol.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Patients considered for TKP according to regular clinical practice;
2. Age < 65 years;
3. Radiological joint damage: Kellgren & Lawrence score above 2;
4. Intact knee ligaments;
5. Normal range-of-motion (min. of 120° flexion; max flexion limitation of 15°);
6. Normal stability;
7. Body Mass Index < 35.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Psychological inabilities or difficult to instruct;
2. Not able to undergo MRI examination (standard protocol);
3. Inflammatory or rheumatoid arthritis present or in history;
4. Post traumatic fibrosis due to fracture of the tibial plateau;
5. Bone-to-bone contact in the joint (absence of any joint space on X-ray);
6. Surgical treatment of the involved knee < 6 months ago;
7. An infectious susceptible prosthesis (joint replacement) in situ;
8. Primary patello-femoral OA.
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 | NL2680 |
| NTR-old | NTR2809 |
| Ander register | METC UMCU : 10-359 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |