Surgical Techniques in Arthroplasty of the Knee (STArK) 1 Trial

NCT03505645 | Unknown Phase 4 DMC

• 1 other identifier: 241807
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Study Background Osteoarthritis of the knee is a common degenerative musculoskeletal condition which affects nearly five million people in the United Kingdom. Some patients will require total knee replacement surgery if their symptoms of pain and disability are not controlled adequately by so-called 'conservative' measures such as weight-loss, activity modification and analgesic (pain-killer) medication. Over the past ten years our understanding of pain-relief strategies during total knee replacement, often termed 'Enhanced Recovery' principles, has helped improve patient care and reduced length of hospital admission. 'Enhanced Recovery' principles recommend the use of analgesic medications which can be delivered in a variety of ways e.g. tablets and injections. This is termed 'multi-modal' analgesia. Prior to total knee replacement, the patient will receive an injection around the nerves in the spine (regional anaesthesia) which numbs the patient from the waist down and allows the surgeon to perform the operation in a safe and pain-free manner. During the operation, surgeons often choose to deliver extra local anaesthetic to prolong the degree of pain-relief in the immediate post-operative period. This can enable patients to mobilise early and is associated with greater long-term satisfaction. There are two main methods of delivering this extra form of pain-relief during the operation. Peri-articular injection involves multiple injections of local anaesthetic into the soft-tissues surround the knee. In contrast, Intra-articular injection involves a single injection directly into the knee joint once the operation is finished. Currently, there is no clear evidence available to Orthopaedic surgeons to inform us which technique is better at providing pain relief for patients undergoing total knee replacement surgery. All patients undergoing total knee replacement surgery for osteoarthritis of the knee will be invited to participate in this study. We intend to recruit a total of 120 patients. During the patient's total knee replacement surgery, they shall receive an injection of local anaesthetic around the soft-tissues of the knee (Peri-Articular Injection) or directly into the knee joint itself (Intra-Articular Injection). The decision regarding which treatment they receive is decided entirely by randomisation. Following the operation, a member of the research team will assess the patient on the ward to collect information regarding levels of pain and overall satisfaction. The type of injection received shall be kept secret from both the patient and the member of the research team collecting the post-operative pain scores. After the patient has been safely discharged from hospital, we intend to follow-up all participants for one year. This will involve routine clinic appointments at six weeks and twelve months following surgery. This will involve review and clinical examination by a member of the orthopaedic team who have treated the patient whilst in hospital and/or a member of the research team. In addition, all patients will be asked to complete a questionnaire at twelve months regarding their level of function and pain. These questionnaires have been used widely in the medical literature and have a strong evidence base for their use. What is the aim of this study? The aim of this study is compare the amount of pain relief provided by two different methods of local anaesthetic injection techniques used in total knee replacement surgery. In addition, we would like to know if this influences the patient's immediate and long-term recovery after surgery.

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• Change in pain levels during first 48 hours after surgery.

  The Visual Analogue Score (VAS) for pain is a well recognised and validated measure of postoperative pain and has been used as a primary outcome measure on other studies comparing analgesic methods at Total Knee Replacement

  Pre-operative baseline and then re-checked at intervals in post-operative period 6, 12, 24 and 48 hours

Secondary Outcomes (4)

• Opiate use first 24 hours

  24 hours

• Length of hospital stay

  Through study completion, at 12 months post-operation.

• Patient Satisfaction

  Through study completion, at 12 months post-operation.

• Change in Oxford Knee Score at 12 months after surgery.

  12 months

Study Arms (2)

Treatment group 1: Periarticular infiltration

ACTIVE COMPARATOR

Patients undergoing total knee replacement who are randomised to Treatment Group 1.

Procedure: Periarticular infiltration

Treatment Group 2: Intra-articular infiltration

ACTIVE COMPARATOR

Patients undergoing total knee replacement who are randomised to Treatment Group 2.

Procedure: Intra-articular infiltration

Interventions

Periarticular infiltration PROCEDURE

The injection will consist of the same drugs for all patients: 150mg levobupivacaine 0.25%, 10mg morphine; and 30mg ketorolac made up to a volume of 150ml with saline. The difference between treatment groups is how the multimodal injection is administered: either by periarticular infiltration around the knee, or by simple intra-articular injection after the knee joint capsule has been closed. Treatment group 1: Periarticular infiltration Intra-operatively after bone cuts have been made and prior to implant cementation, the multimodal injection will be infiltrated around the knee at 6 specific sites: 1. Medial femoral condyle periosteum 2. Medial gutter 3. Lateral femoral condyle periosteum 4. Lateral gutter 5. Posteromedial capsule 6. Posterolateral capsule

Treatment group 1: Periarticular infiltration

Intra-articular infiltration PROCEDURE

The injection will consist of the same drugs for all patients: 150mg levobupivacaine 0.25%, 10mg morphine; and 30mg ketorolac made up to a volume of 150ml with saline. The difference between treatment groups is how the multimodal injection is administered: either by periarticular infiltration around the knee, or by simple intra-articular injection after the knee joint capsule has been closed. After implant cementation and watertight joint capsular closure, the multimodal injection will be injected intra-articularly through the closed capsule.

Treatment Group 2: Intra-articular infiltration

Eligibility Criteria

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

You may qualify if:

• Primary knee osteoarthritis requiring Total Knee Replacement surgery
• Planned for cruciate retaining prosthesis without patella resurfacing
• Patient is able to give informed consent
• Patient resides locally and will be available for follow up

You may not qualify if:

• Inflammatory arthropathy
• Preoperative morphine based analgesia
• Renal insufficiency (GFR\<30)
• Allergy to study drugs
• Spinal anaesthetic not possible
• Neurological disorder affecting the lower limbs

Sponsors & Collaborators

• Chloe Scott: lead
• NHS Lothian: collaborator

Study Sites (1)

Royal Infirmary of Edinburgh

Edinburgh, Scotland, EH16 4SA, United Kingdom

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Chloe Scott, FRCSEd

  NHS Lothian

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chloe Scott, FRCSEd

CONTACT

0131 536 1000; chloeehscott@yahoo.co.uk

Liam Yapp, MRCSEd

CONTACT

liam.yapp@nhs.net

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant Orthopaedic Surgeon

Study Record Dates

• First Submitted: April 4, 2018
• First Posted: April 23, 2018
• Study Start: January 1, 2020
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: March 5, 2019

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)