Use of the Orthoglide for Improved Patient Outcome Following Total Knee Replacement
Condition: Knee Osteoarthritis; Physiotherapy; Intervention; Rehabilitation; Exercise
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      Total knee replacements are a common orthopaedic procedure undertaken at Blackpool Victoria
      Hospital. Following surgery patients are routinely seen by Physiotherapists who prescribe
      exercises to improve the range of movement and strength of the knee joint, thus aiding
      recovery. One of the key exercises prescribed involves the bending and straightening of the
      knee to improve range of movement. At this early stage of rehabilitation , due to weakness in
      the knee joint, reducing any resistance to this motion is beneficial. The Orthoglide device
      is designed to aid the patient in performing this movement by reducing the
      friction/resistance caused by the heel sliding against the bed. Currently this is achieved
      using a 'slider board' and placing a rolled up piece of fabric under the patients heel. The
      aim of this study is to investigate whether or not issuing an Orthoglide device to patients
      following total knee replacements improves functional outcomes reported by the patient at 6
      weeks and 12 weeks post-surgery. Participants will be assigned to either receive an
      Orthoglide device and standard Physiotherapy or standard Physiotherapy alone. A series of
      patient reported outcome measures will be taken pre-surgery, 6 weeks post surgery and 12
      weeks post surgery and the results compared.
    

Detailed description: 
      It is hypothesised that issuing an Orthoglide device following total knee replacement will
      improve patient reported outcomes. The null-hypothesis is that there is no correlation
      between the issuing of an Orthoglide device and improved patient reported outcome measures
      post total knee replacement.

      The following outlines the various stages which the research participants will pass through
      during the study:

        1. Initial contact - having been identified as requiring a total knee replacement the
           patient will attend Blackpool Victoria Hospital for a routine pre-operative assessment.
           During this contact the patient will be given an information pack relating to the
           project, this patient information sheet will include an invitation to participate,
           information regarding confidentiality, contact information as well as a consent form to
           be taken away and considered at home.

        2. Homeward visit - The Homeward team routinely complete home visits with all patients who
           are awaiting a total knee replacement. During this visit the clinician will further
           discuss the study and, if the patient wishes to take part, the consent forms may be
           collected. The visiting clinician will store these sealed envelopes in-line with trust
           policy on data protection - in a lockable drawer/cabinet upon return to the hospital,
           this will only be accessible by the Homeward Team and research team.

        3. Establishing baseline measurements - Consent forms will be reviewed by Robyn Jones and a
           copy placed in the patients records. Contact details will be recorded on secure access
           computer folder and participants contacted on preferred telephone number to establish
           baseline scores of outcome measures, gaining verbal consent prior to commencing. Consent
           forms will be stored in patients notes via coding with a further copy remaining in a
           secured storage location only accessible by the research team, for our records. Outcome
           measure scores will be inputted onto an anonymised and encrypted spreadsheet which will
           be stored on a password protected computer folder.

        4. Randomisation - Due to the time period the trial will take place over the investigators
           will employ block randomisation to allow the participants to be grouped in a timely
           manner prior to their surgery. Once the participants identity has been anonymised and
           encrypted participants will be randomised in groups of 10, i.e. every 10 patients
           recruited will be randomised as one block. This process will repeat for every group of
           10 recruited until capacity is reached for the intervention group and the control group.
           As a feasibility study it is estimated that 30 participants in each arm will be
           sufficient to give adequate power.

        5. Identification of participants on weekly operation list - The Orthopaedic Physiotherapy
           team routinely access operation lists to identify the appropriate patients for
           Physiotherapy input. These operation lists will be cross referenced with our participant
           list to identify those taking part in the study and which group participants have been
           randomised into.

        6. Patients will attend Blackpool Victoria Hospital for surgery. Routine post-operative
           Physiotherapy rehabilitation protocols will be followed with the only variation being
           the issue of an Orthoglide device to those in the study group and not to those in the
           control group - as identified in stage 5. Patients generally remain an in-patient for
           approximately 3 days post surgery.

        7. 6 week follow up call - 6 weeks after the date of surgery (recorded in the secured
           spreadsheet from the weekly operation list)the research team will contact the patient to
           complete the outcome measures as used in stage 3, this data will be inputted onto the
           anonymised and encrypted spreadsheet stored on a password protected computer.

        8. 12 week follow up call - 12 weeks after the date of surgery the research team will
           contact the patient to complete the outcome measures as used in stage 3 and 7, this data
           will be inputted onto the anonymised and encrypted spreadsheet stored on a password
           protected computer.

        9. Data analysis and write up - Once all data is collected it will be analysed using the
           appropriate statistical analysis method and software. This study is designed to cause as
           little disruption to the routine patient journey as possible. Outside of routine
           contacts made by the direct care team, the only additional commitments participants must
           make is to be contacted by telephone by the research team 3 times (pre-operative
           baseline, 6 week follow-up and 12 week follow-up), each lasting approximately 20-15
           minutes. It is estimated that from recruitment a participant will be involved with the
           study for a maximum of 24 weeks - preoperative clinics must be no more than 12 weeks
           prior to the surgery and the second follow-up phone call will be 12 weeks post
           operation. The overall timeframe for the project will be 24 months from April 2018 to
           April 2020, this includes ethics applications, data collection (to begin from November
           2018), analysis and write up. Both arms of the trial will receive the same amount of
           Physiotherapy input (2 x daily visits) during their in-patient stay.

      The only variable will be the issue of an Orthoglide device for the trial group to assist
      with completion of their knee exercises instead of a 'slider-board'. As a feasibility study
      no interim reports are planned however as soon as data has been analysed and reported upon it
      will be made available to the participants. participants will be randomised using block
      randomisation and data sets anonymised for analysis thus minimising researcher bias by all
      reasonable means for a study of this nature.
    

Intervention name(s): Orthoglide; Physiotherapy only
Intervention type(s): Device; Other
Intervention description(s): Knee rehabilitation device.; Physiotherapy only.
Other intervention name(s): Physiotherapy
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Group 1: Physiotherapy with Orthoglide
Group 2: Physiotherapy only
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Knee Osteoarthritis; Orthoglide; Knee exercises; KOOS; rehabilitation