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Surgical Techniques in Arthroplasty of the Knee (STArK) 1 Trial (STArK1)

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ClinicalTrials.gov Identifier: NCT03505645
Recruitment Status : Not yet recruiting
First Posted : April 23, 2018
Last Update Posted : March 5, 2019
Sponsor:
Collaborator:
NHS Lothian
Information provided by (Responsible Party):
Chloe Scott, Royal Infirmary of Edinburgh

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.


Condition or disease Intervention/treatment Phase
Pain, Postoperative Procedure: Periarticular infiltration Procedure: Intra-articular infiltration Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Surgical Techniques in Arthroplasty of the Knee (STArK) 1 Trial: Periarticular Infiltration Versus Intra-articular Injection for Postoperative Analgesia in Primary Total Knee Arthroplasty: a Randomised Double Blind Controlled Trial
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Active Comparator: Treatment group 1: Periarticular infiltration
Patients undergoing total knee replacement who are randomised to Treatment Group 1.
Procedure: Periarticular infiltration

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

Active Comparator: Treatment Group 2: Intra-articular infiltration
Patients undergoing total knee replacement who are randomised to Treatment Group 2.
Procedure: Intra-articular infiltration

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.





Primary Outcome Measures :
  1. Change in pain levels during first 48 hours after surgery. [ Time Frame: Pre-operative baseline and then re-checked at intervals in post-operative period 6, 12, 24 and 48 hours ]
    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


Secondary Outcome Measures :
  1. Opiate use first 24 hours [ Time Frame: 24 hours ]
    We will record amount of regular and as required opiates required for pain relief in initial recovery period.

  2. Length of hospital stay [ Time Frame: Through study completion, at 12 months post-operation. ]
    Measurement of duration of hospital admission following elective total knee replacement.

  3. Patient Satisfaction [ Time Frame: Through study completion, at 12 months post-operation. ]
    Patients will be asked to rate their level of satisfaction with operation and recovery using Likert scale.

  4. Change in Oxford Knee Score at 12 months after surgery. [ Time Frame: 12 months ]
    The Oxford Knee Score (OKS) is a validated measure of pain and function following total knee replacement. The OKS is comprised of 12 questions which can be scored from 0 to 4 (with 0 being the worst outcome and 4 being the best outcome). The scores are then summed up to produce an overall score running from 0 (worst possible) to 48 (best possible). The OKS has sub-scales based on 'Functional Components' (questions 2, 3, 7, 11, 12) and 'Pain Components' (Questions 1, 4, 5, 6, 8, 9, 10). A raw score is created for each sub-scale based on the 0-4 scoring system. To enable easier interpretation, each sub-scale is standardised to a range from 0 (worst possible) to 100 (best possible). This is done by multiplying the 'Functional Component' raw score by 5 and 'Pain Component' score by 3.57. We intend to record and report the change in Pre-operative and 12 months post-operative OKS using the total score and also providing data on the Pain and Functional Component scores.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03505645


Contacts
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Contact: Chloe Scott, FRCSEd 0131 536 1000 chloeehscott@yahoo.co.uk
Contact: Liam Yapp, MRCSEd liam.yapp@nhs.net

Locations
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United Kingdom
Royal Infirmary of Edinburgh Not yet recruiting
Edinburgh, Scotland, United Kingdom, EH16 4SA
Contact: Chloe Scott, FRCSEd       chloeehscott@yahoo.co.uk   
Contact: Liam Yapp, MRCSEd       liam.yapp@nhs.net   
Principal Investigator: Chloe Scott, FRCSEd         
Sub-Investigator: Liam Yapp, MRCSEd         
Sponsors and Collaborators
Chloe Scott
NHS Lothian
Investigators
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Principal Investigator: Chloe Scott, FRCSEd NHS Lothian

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Responsible Party: Chloe Scott, Consultant Orthopaedic Surgeon, Royal Infirmary of Edinburgh
ClinicalTrials.gov Identifier: NCT03505645     History of Changes
Other Study ID Numbers: 241807
First Posted: April 23, 2018    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No patient identifiable data shall be available to anyone other than the trial researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms