Surgery Induced Trauma After Total Versus Medial Unicompartmental Knee Arthroplasty (SITA)

NCT05735847 | Active Not Recruiting

• 1 other identifier: H-22029746
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

Osteoarthritis (OA) is the most common type of arthritis, characterized by pain and physical disability. More than 10% of persons \> 55 years have symptomatic OA, primarily involving the knees. Knee arthroplasty is considered a successful orthopaedic procedure in progressed knee OA (KOA) with severe pain and disability where non-surgical treatments have been tried. It has long been recognized that injury to the body, either from trauma or surgery causes an inflammatory response. As TKA is considered a more invasive procedure compared with UKA, TKA and UKA may not trigger inflammatory reactions of the same magnitude. Differences in inflammatory response between TKA and UKA could help explain why differences in outcome are present, despite both procedures being technically successful. Even though knee arthroplasty is a very common and successful procedure, there are no existing studies comparing the invasiveness of TKA and UKA. As morbidity and mortality rates differ between the groups, the aim of this prospective cohort study is to investigate whether the post-operative inflammatory responses differ between TKA and UKA, and secondarily whether this difference can explain the difference in outcome between the two procedures. The investigators hypothesize that TKA generates a larger postoperative systemic inflammatory response compared with UKA due to more extensive periarticular soft tissue and bone trauma. The study's primary outcome is C-reactive Protein (CRP) measured in blood 24 hours after surgery (22-26 hours after surgery \~ day 1). Participants which are candidates for either a TKA or a UKA will through serial blood test measurement have their postoperative systemic inflammatory response measured. This further will be correlated to the clinical and functional outcomes over a 2-years postoperative follow-up period.

Conditions

Knee Osteoarthritis; Arthritis; Surgery; Total Knee Arthroplasty; Unicompartmental Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

• C-reactive protein (CRP)

  Marker of systemic inflammation and soft tissue injury

  Day 1 (24 hours after surgery)

Secondary Outcomes (30)

• Interleukin-1-beta (IL1-beta)

  Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)

• Interleukin-6 (IL6)

  Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)

• Interleukin-8 (IL8)

  Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)

• Tumor necrosis factor alfa (TNF-alfa)

  Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)

• Metalloproteinases (MMP3, MMP9, MMP13)

  Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)

Study Arms (2)

Total Knee Arhroplasty (TKA)

Study participants will be adults (i.e. at least 18 years old) who have diagnosis of KOA with an indication for primary Total Knee Arthroplasty (TKA).

Procedure: Total Knee Arthroplasty (TKA)

Unicompartmental Knee Arthroplasty (UKA)

Study participants will be adults (i.e. at least 18 years old) who have diagnosis of KOA with an indication for primary medial Unicompartmental Knee Arthroplasty (UKA).

Procedure: Unicompartmental Knee Arthroplasty (UKA)

Interventions

Total Knee Arthroplasty (TKA) PROCEDURE

The choice between TKA and UKA is based on the radiological presentation of the knee KOA on an x-ray. A surgery with TKA involves the replacement of both the medial and lateral compartments of the knee.

Total Knee Arhroplasty (TKA)

Unicompartmental Knee Arthroplasty (UKA) PROCEDURE

The choice between TKA and UKA is based on the radiological presentation of the knee KOA on an x-ray. A surgery with UKA involves the replacement of one compartment.

Unicompartmental Knee Arthroplasty (UKA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study participants will be adults (i.e. at least 18 years old) who have diagnosis of KOA with an indication for primary KA (medial unicondylar or total arthroplasty).

You may qualify if:

• Age 18 or more
• A clinical and radiological diagnosis of knee OA
• Candidate for spinal anaesthesia
• signed informed consent

You may not qualify if:

• Planned surgery within the observation period other than KA
• Any contraindications to the use of torniquet during surgery
• Any contraindication to the administration of pre-operative dexamethasone
• KA indication due to sequelae of e.g. fracture(s)
• Previous infection of the target knee joint
• Injection of medication or substances in the target knee within 3 months prior to participation
• Immuno-inflammatory arthritis as cause of knee OA
• Known autoimmune and/or inflammatory disease e.g. colitis ulcerosa
• Active cancer diagnosis with ongoing treatment
• Current systemic treatment with glucocorticoids equivalent to \> 7.5 mg prednisolone/day
• Infection requiring medical/surgical treatment within the last 4 weeks prior to surgery for KA
• Neurological dysfunction compromising mobility
• Inability to understand or read Danish incl. instructions and questionnaires
• Any other condition or impairment that, in the opinion of the investigator (or his/her delegate), makes a potential participant unsuitable for participation or which obstruct participation.

Sponsors & Collaborators

• Hvidovre University Hospital: lead
• Frederiksberg University Hospital: collaborator
• Parker Research Institute: collaborator

Study Sites (1)

Department of Orthopaedic Surgery, Amager Hvidovre Hospital

Hvidovre, 2650, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

CRP, Interleukin-1-beta(IL1-beta), interleukin-6 (IL6), Interleukin-8(IL8), tumor necrosis factor alfa (TNF-alfa), Metalloproteinases (MMP3, MMP9, MMP13), calprotectin - S100 calcium binding protein A8/A9 (S100A8/S100A9), S100 calcium-binding protein B (S100B), CRP, Haemoglobin (Hb), Erytrocyte Sedimentation Rate (ESR), White cell count (L+D), Platelets, Myoglobin, Lactate dehydrogenase (LDH), Creatine Kinase (CK).

MeSH Terms

Conditions

Osteoarthritis, Knee; Arthritis

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Anders Troelsen, MD, PhD, DMSc

  Department of Orthopaedic Surgery, Amager Hvidovre Hospital, Kettegård Alle 30, DK-2650 Hvidovre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Clinical Orthopaedic Surgery Hvidovre (CORH), Clinical Professor

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: February 21, 2023
• Study Start: February 20, 2023
• Primary Completion: March 30, 2024
• Study Completion: March 30, 2026
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)