Role of Two Rehabilitative Treatments and Diet in the Modulation of Inflammation in Patients With Knee Prosthesis.
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.
1 other identifier
interventional
34
1 country
2
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2019
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 30, 2019
CompletedFirst Submitted
Initial submission to the registry
September 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2020
CompletedFirst Posted
Study publicly available on registry
October 8, 2020
CompletedOctober 8, 2020
October 1, 2020
1 year
September 30, 2020
October 7, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
CRP variation
blood test
21 days
ESR variation
blood test
21 days
lower limb oedema
leg circumference
21 days
Study Arms (3)
Lymphatic drainage
EXPERIMENTALPatients subjected to manual lymphatic drainage
Connective tissue
EXPERIMENTALPatients subjected to connective tissue massage
control group
ACTIVE COMPARATORSubjects hat followed standard rehabilitative treatment
Interventions
The interventions follow the validated techniques normally used in international rehabilitation
Eligibility Criteria
You may qualify if:
- \<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
You may not qualify if:
- Joint replacements from other Units
- Inflammatory arthropathies
- Autoimmune / rheumatic diseases
- Obesity
- Diabetes mellitus
- Infections
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
presidio ospedaliero di Asiago
Asiago, Vicenza, 36012, Italy
ULSS 7 Pedemontana
Asiago, Vicenza, 36012, Italy
Related Publications (1)
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.
PMID: 34099953DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sergio Rigoni
Presidio Ospedaliero di Asiago
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Sergio Rigoni
Study Record Dates
First Submitted
September 30, 2020
First Posted
October 8, 2020
Study Start
September 30, 2019
Primary Completion
September 30, 2020
Study Completion
September 30, 2020
Last Updated
October 8, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share