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Knee Joint Distraction in comparison with Total Knee Prosthesis in treatment of knee osteoarthritis.

- candidate number9240
- NTR NumberNTR2809
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-mrt-2011
- Secondary IDs10-359 METC UMCU
- Public TitleKnee Joint Distraction in comparison with Total Knee Prosthesis in treatment of knee osteoarthritis.
- Scientific TitleJoint distraction in treatment of knee osteoarthritis: A comparison with a presently applied surgical alternative, total knee prosthesis.
- hypothesisThe 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).
- Healt Condition(s) or Problem(s) studiedOsteoarthritis, Knee
- Inclusion criteria1. 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.
- Exclusion criteria1. 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2011
- planned closingdate1-dec-2013
- Target number of participants60
- InterventionsKJD 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.
- Primary outcomeClinical effectiveness determined by WOMAC at two years.
- Secondary outcome1. Clinical effectiveness determined by KOOS;
2. Pain evaluated with VAS score;
3. Indication of cost-effectiveness;
4. Structural repair of cartilage as determined on X-rays, MRI and biomarker analysis (only in patients treated with KJD) in comparison with own baseline values.
- TimepointsBaseline (2x), 3 and 6 weeks, 3, 6, 9, 12, 18 and 24 months follow-up.
- Trial web siteN/A
- statusopen: patient inclusion
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development, University Medical Center Utrecht (UMCU)
- PublicationsN/A
- Brief summaryThis, 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.
- Main changes (audit trail)
- RECORD14-mrt-2011 - 29-mrt-2011

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