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INFLUENCE OF TITANIUM-NITRIDE COATING OF CEMENTLESS MOBILE BEARING TOTAL KNEE PROSTHESIS ON THE INCIDENCE OF POSTOPERATIVE PAIN AND SYNOVITIS; A RANDOMIZED CLINICAL TRIAL.


- candidate number10243
- NTR NumberNTR3033
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR12-aug-2011
- Secondary IDs2005/194 METC VUmc
- Public TitleINFLUENCE OF TITANIUM-NITRIDE COATING OF CEMENTLESS MOBILE BEARING TOTAL KNEE PROSTHESIS ON THE INCIDENCE OF POSTOPERATIVE PAIN AND SYNOVITIS; A RANDOMIZED CLINICAL TRIAL.
- Scientific TitleINFLUENCE OF TITANIUM-NITRIDE COATING OF CEMENTLESS MOBILE BEARING TOTAL KNEE PROSTHESIS ON THE INCIDENCE OF POSTOPERATIVE PAIN AND SYNOVITIS; A RANDOMIZED CLINICAL TRIAL.
- ACRONYM
- hypothesisTiN coating of a cementless mobile bearing rotating platform total knee prosthesis reduces the incidence of postoperative pain and synovitis.
- Healt Condition(s) or Problem(s) studiedPain, Total knee arthroplasty, Synovitis, Titanium nitrate, Chromium-cobalt
- Inclusion criteria1. Indication for TKA;
2. Age of 18 years or older;
3. Ability to give informed consent.
- Exclusion criteria1. Revision TKA;
2. Previous TKA on the contralateral side within the last year because of possible swelling and limited mobility or previous TKA with persisting pain;
3. Neurological disabilities;
4. Psychiatric disorders;
5. No informed consent.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 27-jul-2006
- planned closingdate4-jun-2012
- Target number of participants100
- Interventions1. CrCo cementless mobile bearing TKA;
2. TiN coated CrCo cementless mobile bearing TKA.
- Primary outcome1. VAS score;
2. Knee circumference in centimeters;
3. Knee skin temperature in degrees Celsius.
- Secondary outcomeKnee range of motion and complications.
- TimepointsPreoperative, 6 weeks, 6 months, 1 year and 5 years.
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESMD. R.P. Hove, van
- CONTACT for SCIENTIFIC QUERIESMD. PhD. P.A. Nolte
- Sponsor/Initiator Spaarne Hospital
- Funding
(Source(s) of Monetary or Material Support)
Foundation of Orthopedic Research Spaarne Hospital Hoofddorp
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD12-aug-2011 - 8-sep-2011


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