The main objective of this study is to test if resection of Hoffa*s fat pad in total knee arthroplasty leads to a greater range of motion and if resection leads to a faster recovery of normal walking gait and preferred walking speed post operatively…
ID
Source
Brief title
Condition
- Joint disorders
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Range of motion at 6 weeks and 3 and 12 months. Gait parameters and preferred
walking speed at 3 and 12 months
Secondary outcome
VAS anterior knee pain score 1 week diary at 6 weeks and 3 and 12 months
KOOS and Kujala score at 6 weeks and 3 and 12 months
Complications and adverse events
Background summary
Hoffa*s fat pad has been associated with anterior knee pain after total knee
arthroplasty. Furthermore, fibrosis of Hoffa*s fat pad due to the incision
technique is associated with a decreased range of motion. It*s resection is
reported to result in less pain after surgery.
Study objective
The main objective of this study is to test if resection of Hoffa*s fat pad in
total knee arthroplasty leads to a greater range of motion and if resection
leads to a faster recovery of normal walking gait and preferred walking speed
post operatively and at follow-up. Secondary Objectives are to see if, as a
result of resection of Hoffa*s fat pad patients have less anterior knee pain, a
higher KOOS and Kujala score and better patient satisfaction. Furthermore, we
shall assess if resection leads to a higher risk of adverse events due to this
procedure.
Study design
Clinical randomised controlled double blind trial.
Intervention
One group will undergo Hoffa*s fat pad resection and one group will not, during
implantation of a total knee prosthesis.
Study burden and risks
The risk associated with participation in this study is considered minimal.
Hoffa*s fat pad is often resected to gain better exposure and no adverse events
have been reported after this procedure. The treatment and peri-operative
protocol will be the standard Joint-Care like protocol of the Medical Centre
Alkmaar and will be the same for all patients. The extra burden of
participating in this study will be one extra follow-up visit at 3 months post
operatively and the filling out of the KOOS and Kujala questionnaire at
follow-up visits. Furthermore, all patients shall undergo a 50 meter walking
registration which is not in the normal clinical protocol.
Wilhelminalaan 12
Alkmaar 1815JD
NL
Wilhelminalaan 12
Alkmaar 1815JD
NL
Listed location countries
Age
Inclusion criteria
- Patients who are planned to undergo a primary total knee arthroplasty in the Joint-Care program of the Medical Centre Alkmaar.
- Age between 30 and 80 years
- Patients with ASA Physical Status I & II
Exclusion criteria
- Patients with another prosthesis in either one of the lower extremities
- Patients diagnosed with rheumatoid arthritis
- Patients who suffer from insulin dependant diabetes
- Patients who lack understanding of the Dutch language
- Patients who are treated for or diagnosed with neurological or muscle disorders which make assessment of pain and gait not possible
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL39455.094.12 |