Clinical trial NCT04580069: Role of Two Rehabilitative Treatments and Diet in the Modulation of Inflammation in Patients With Knee Prosthesis.
Official title: Effectiveness of Two Rehabilitative Treatments in the Modulation of Inflammation During the Acute Phase in Patients With Knee Prosthesis and Assessment of the Role of the Diet in Determining Post-surgical Inflammation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Pain Swelling
Keywords: total Knee Arthroplasty (TKA)
C-reactive protein (CRP)
erythrosedimentation rate (ESR)
Over Knee Oedema (EDO)
Under Knee Oedema (EDU)
MEDIET Questionnaire
Lead sponsor: Presidio Ospedaliero di Asiago
Sponsor class: OTHER
First posted: 2020-10-08
Enrollment: 34
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

Brief summary: The investigators studied the influence of two aproved rehabilitative treatments, connective tissue techniques and lymphatic drainage, on acute inflammation markers. Furthermore, the role of mediterranean diet on the same values was investigated in the first postoperative period

Detailed description: The main objective of this study is to demonstrate the effectiveness of lymphatic drainage and connective tissue techniques in modulating systemic inflammation. Another objective is to evaluate the existence, at baseline, of a correlation between the inflammation indices and the level of adherence to the Mediterranean diet.

Methods. 34 patients were recruited, and divided into three groups. The control group followed the normal rehabilitation protocol. The other two groups were subjected, in addition to the standard treatment, to manual lymphatic drainage treatment or connective tissue techniques. The outcomes (PCR, ESR, Oedema) were recorded in three stages: upon entering the hospital, 1 week after entry and at follow-up 21 days after surgery.

Eligibility criteria: Inclusion criteria

* 50\<age\<80 years
* Bicompartmental knee arthroplasty
* Weight bearing 7 days after surgery
* Transfusions according to hospital protocol
* Alteration of the indices at T0
* Standard analgesic therapy

Exclusion Criteria:

* Joint replacements from other Units
* Inflammatory arthropathies
* Autoimmune / rheumatic diseases
* Obesity
* Diabetes mellitus
* Infections

Primary outcomes:
measure: CRP variation
timeFrame: 21 days
measure: ESR variation
timeFrame: 21 days
measure: lower limb oedema
timeFrame: 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: Asiago
country: Italy
facility: presidio ospedaliero di Asiago
state: Vicenza
city: Asiago
country: Italy
facility: ULSS 7 Pedemontana
state: Vicenza
Study officials:
affiliation: Presidio Ospedaliero di Asiago
name: Sergio Rigoni
role: STUDY_DIRECTOR
References:
citation: Rigoni S, Tagliaro L, Bau D, Scapin M. Effectiveness of two rehabilitation treatments in the modulation of inflammation during the acute phase in patients with knee prostheses and assessment of the role of the diet in determining post-surgical inflammation. J Orthop. 2021 May 15;25:237-243. doi: 10.1016/j.jor.2021.05.016. eCollection 2021 May-Jun.