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The effect of Hoffa's fat pad resection in total knee arthroplasty.

- candidate number14292
- NTR NumberNTR3826
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR30-jan-2013
- Secondary IDsM012-009 / NL39455.094.12 MCA / CCMO
- Public TitleThe effect of Hoffa's fat pad resection in total knee arthroplasty.
- Scientific TitleThe effect of Hoffa's fat pad resection in total knee arthroplasty on functionality and pain: A double blind randomized clinical trial.
- hypothesisIt is hypothesized that Hoffa’s fat pad resection in total knee arthroplasty leads to a greater range of motion, a faster recovery of normal walking gait and preferred walking speed, less anterior knee pain, a higher KOOS score and better patient satisfaction post operatively and at follow-up.
- Healt Condition(s) or Problem(s) studiedTotal knee arthroplasty, Hoffa’s fat pad, Pain, Function
- Inclusion criteria1. Patients who are planned to undergo a primary total knee arthroplasty in the Joint-Care program of the Medical Centre Alkmaar;
2. Age between 30 and 80 years;
3. Patients with ASA Physical Status I & II.
- Exclusion criteria1. Patients with another prosthesis in either one of the lower extremities;
2. Patients diagnosed with rheumatoid arthritis;
3. Patients who suffer from insulin dependant diabetes;
4. Patients who lack understanding of the Dutch language;
5. Patients who are treated for or diagnosed with neurological or muscle disorders which make assessment of pain and gait not possible.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2013
- planned closingdate1-mrt-2015
- Target number of participants90
- InterventionsOne group will undergo Hoffa’s fat pad resection and one group will not during implantation of a total knee prosthesis.
- Primary outcome1. Active and passive knee range of motion;
2. Gait parameters;
3. Walking stability and variability.
- Secondary outcome1. The prevalence and severity of (anterior) knee pain;
2. The KOOS score (Knee Injury and Osteoarthritis Outcome Score);
3. Complications and adverse events. patellar tendon lenght.
- TimepointsPre-op, day of discharge, 6 weeks post-op, 3 months post-op and 12 months post-op.
- Trial web siteN/A
- statusplanned
- Sponsor/Initiator Medisch Centrum Alkmaar
- Funding
(Source(s) of Monetary or Material Support)
CORAL, Department of Orthopaedic Surgery, Medisch Centrum Alkmaar
- PublicationsN/A
- Brief summaryLittle is known about the function of Hoffa’s fat pad in both the normal knee as well as in case of a knee prosthesis. Literature indicates that the fat pad may play a, possibly detrimental, role in modulating inflammatory and destructive responses in knee osteoarthritis. However, in total knee arthroplasty all cartilage is removed and this role of Hoffa’s fat pad can therefore be considered irrelevant. Furthermore, Hoffa’s fat pad is considered to be a source of anterior knee pain and may limit the function of the prosthetic knee, possibly in association with the prevalence of fibrosis. Henceforth our hypotheses are that resection of Hoffa’s fat pad in total knee arthroplasty leads to 1) a greater range of motion and recovery of range of motion closer to the preoperative range of motion during follow-up, 2) less anterior knee pain during follow-up, 3) a faster recovery and enhanced values of gait parameters, such as preferred walking speed and variation in knee angle during walking.
- Main changes (audit trail)
- RECORD30-jan-2013 - 21-feb-2013

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