Infrapatellar Fat Pad Preservation Versus Resection on Clinical Outcomes After Total Knee Arthroplasty(IPAKA)
Keywords
Abstract
Description
Knee Osteoarthritis (KOA) is a common chronic disease, which often leads to joint pain and limited function in the elderly, and thus affects participants' quality of life. Total knee arthroplasty (TKA) has been developed as a mature surgical procedure to relieve end-stage osteoarthritic joint pain and improve limb function. Although more than 80% of the patients reported in the literature are satisfied with the postoperative efficacy of TKA, there are still a large number of patients whose daily life is affected by persistent knee pain and limited function after the operation of the affected limb.
The IPFP is a fat mass located behind the patellar ligament, between the lower part of the patella and the tibial tubercle. The function of IPFP is controversial at present. It is reported that IPFP can provide blood supply for anterior cruciate ligament, patella and patellar ligament through the arterial network of the knee joint. In addition, it can fill the joint gap to lubricate the surface of the joint, reduce friction and absorb impulse so as to play a physiological protective role. On the contrary, studies have pointed out that abnormal IPFP could produce various pro-inflammatory cytokines such as interleukin (IL)-1β, tumour necrosis factor (TNF)-α, IL-6 and IL-8, as well as adipokines such as leptin and resistin, and thus might play a detrimental role in knee OA. Traditionally, the IPFP has been removed in order to improve surgical exposure and to prevent interposition during baseplate implantation. Despite the significant evolution of TKA technology which no longer requires the resection of IPFP for better surgical access, IPFP is still partially or totally resected in around 88% of TKAs.
The investigators' previous population-based cohort study revealed that IPFP maximal area and volume were associated with reduced knee pain, decreased loss of cartilage volume and reduced risks of cartilage defect progression, indicating a beneficial effect of IPFP size. On the other hand, the investigators' further investigation demonstrated that IPFP signal intensity alteration was negatively associated with maximum area of IPFP, and moreover, associated with increased knee cartilage defects, subchondral bone marrow lesion (BML) and knee pain, suggesting IPFP with abnormal quality may play a detrimental role in knee OA. Based on these findings, the investigators proposed that IPFP with normal quality should be preserved or not damaged during TKA, while IPFP with abnormal quality should be resected. This multicentre randomised controlled trial is designed to test the investigators' hypotheses: in patients with normal IPFP quality, preservation of IPFP during TKA procedure will reduce postoperative knee symptoms and improve joint function, comparing with IPFP resection during TKA procedures; in patients with abnormal IPFP quality, resection of IPFP during TKA procedure will reduce postoperative knee symptoms and improve joint function, comparing with IPFP preservation during TKA procedures. The results would provide evidence-based recommendations on clinical practice to improve OA patients' postoperative outcomes.
Three hundred and sixty eligible participants will be recruited and identified as having normal IPFP quality (signal intensity alteration score ≤ 1) or abnormal IPFP quality (signal intensity alteration score ≥ 2). Participants in each site will be randomly allocated to IPFP resection group or preservation group using computer-generated block randomisation.
Dates
| Last Verified: | 01/31/2020 |
| First Submitted: | 10/18/2018 |
| Estimated Enrollment Submitted: | 12/02/2018 |
| First Posted: | 12/03/2018 |
| Last Update Submitted: | 02/23/2020 |
| Last Update Posted: | 02/25/2020 |
| Actual Study Start Date: | 12/16/2018 |
| Estimated Primary Completion Date: | 09/30/2020 |
| Estimated Study Completion Date: | 09/30/2020 |
Condition or disease
Intervention/treatment
Procedure: Infrapatellar Fat Pad Preservation
Procedure: Infrapatellar Fat Pad Resection
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: Infrapatellar Fat Pad Preservation The IPFP retention of more than 80% in actual operation shall be regarded as IPFP retention. | Procedure: Infrapatellar Fat Pad Preservation In the IPFP preservation group, IPFP (more than 80%) will be preserved by retracting out of the operative field. |
| Active Comparator: Infrapatellar Fat Pad Resection In the clinical practice, more than 80% of IPFP volume is commonly resected by surgeons during total knee arthroplasty. The investigators hereby define resection of more than 80% IPFP volume as IPFP excision. | Procedure: Infrapatellar Fat Pad Resection In the IPFP resection group, more than 80% IPFP will be resected during the total knee arthroplasty. |
Eligibility Criteria
| Ages Eligible for Study | 40 Years To 40 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion Criteria: - Participants diagnosed with knee osteoarthritis by X-ray plain film (Kellgren-Lawrence score of ≥ 2) - The need for TKA was confirmed after evaluation by the orthopedic surgeon - One week before surgery, knee pain 100mm pain visual analogue scale score was greater than 20mm - Understanding of the study requirements and willing to participate in this study Exclusion Criteria: - Rheumatoid arthritis,psoriatic arthritis,lupus,malignant tumor - Requiring contralateral TKA within one year - The visual analogue score of 100mm of knee pain before operation was less than 20mm - Having a possible or planned pregnancy - With poor compliance - Suffering from somatic disease, psychiatric or cognitive disorders, neurological disorders that will compromise the safety, compliance, consent, participation, follow-up and the interpretation of the results - Severe knee valgus - Contraindications with TKA or MRI |
Outcome
Primary Outcome Measures
1. The total score of Knee Injury and Osteoarthritis Outcome Score(KOOS) [From pre-operation to 12 months after operation]
2. The functional subscale score of Knee Injury and Osteoarthritis Outcome Score(KOOS) [From pre-operation to 12 months after operation]
Secondary Outcome Measures
1. Other subscales of Knee Injury and Osteoarthritis Outcome Score (KOOS) [From pre-operation to 12 months after operation]
2. Knee Society Score(KSS) [From pre-operation to 12 months after operation]
3. Self-reported efficacy of reduced pain and increased quality of life [From pre-operation to 12 months after operation]
4. Insall - Salvati Ratio (ISR) [From pre-operation to 12 months after operation]
5. Timed Up and Go test [From pre-operation to 12 months after operation]
6. Visual Analogue Scale (VAS) Pain [From pre-operation to 12 months after operation]
