STAK Tool for Treatment of Arthrofibrosis Post Total Knee Replacement
Condition: Arthrofibrosis
Study type: Interventional

Summary: 
      A common complication following total knee replacement (TKR) is arthrofibrosis, a severe
      stiffening of the knee caused by scar tissue.

      The aims of this mixed methods feasibility study are to (1) record the effect of use of the
      STAK Tool on knee flexion active range of movement (KROM) immediately following 8 weeks use
      and 6 months following use, (2) explore patients' experiences of arthrofibrosis and use of
      the STAK Tool, (3) Consider appropriate outcome measures (e.g. KROM, patient
      experience/acceptability, The Western Ontario and McMaster Universities Osteoarthritis Index
      (WOMAC), Oxford Knee Score (OKS) and other clinical measures and (4) design a protocol to
      evaluate the effectiveness of the STAK Tool.
    

Detailed description: 
      Arthrofibrosis most commonly occurs after total knee replacement (TKR), extensive
      intra-articular injury or surgical procedures, for example fracture of the proximal tibia or
      distal femur or multiple ligament reconstructions (Creighton and Bach 2012). Arthrofibrosis
      involves a severe stiffening of the knee caused by scar tissue. This often results in a lack
      of crucial range of knee flexion movement. Traditional physiotherapy treatment includes a
      home exercise programme involving regular intense stretches and mobilisations delivered by
      the physiotherapist at the hospital aiming to enable the patient to regain optimal,
      functional knee bend. The inflammatory process and remodeling of soft tissues following
      trauma can lead to production of scar tissue and subsequent stiffness. This results in
      increased pain and difficulty in performing exercises. This often limits progress requiring
      high numbers of physiotherapy sessions and potentially further surgery (manipulation under
      anaesthetic) to restore range of movement.

      The STAK Tool enables the patient to perform intense self-stretching of the knee more easily
      and effectively. Intense stretching is essential to increase KROM (Bonutti et al 2008,
      Bonutti 2010, Papotto et al 2012, Stephenson et al 2010). Patients who fall into the category
      of having restricted KROM (less than 70 degrees flexion) and those whose Clinicians identify
      them as requiring further intensive physiotherapy to address their stiffness would be
      approached to take part in this study. 36 participants would be recruited. Participants would
      be over 18 years old, between 44kg and 159kg. This mixed methods feasibility study would
      investigate patients' progress and outcomes in overcoming arthrofibrosis using the STAK Tool
      a medical stretching device at home plus standard physiotherapy treatment (intervention
      group), compared to patients receiving physiotherapy treatment only (comparative group).
      Participants would be allocated into either the intervention or comparative group.
      Participants would be instructed to use the STAK Tool for 5-10 minute periods for a minimum
      total of 20 minutes and maximum of 60 minutes a day.

      Participants would receive their standard physiotherapy treatment including KROM, full weight
      bearing exercises including sit to stands, squats, body weight assisted passive stretches,
      strengthening exercises and mobilisations. Angle of knee flexion would be measured
      (standardised method) by the Principal Investigator and the WOMAC and OKS are administered on
      the day the participant consents to the study (Visit 1), the day the intervention starts.
      This will be within approximately 2 weeks of the patient being identified by their clinician.
      (The Principal investigator will visit the participant within 10 days to ensure there are no
      problems using the STAK Tool (Visit 2 - only intervention group). During Visit 1 an interview
      (interview 1), would be conducted to explore the patients' initial thoughts on the STAK Tool
      after being introduced to it. Both the intervention and comparative groups will have their
      KROM recorded using two different measuring instruments, the universal goniometer and the
      Hudl Ubersense App. Outcome measures including KROM, WOMAC and OKS will be recorded again
      following approximately 8 weeks treatment (dependent on time available before manipulation as
      per normal clinical care), at either the patient's final follow-up with their Clinician or at
      their home (Visit 3) (end of intervention). The WOMAC and OKS would help to ascertain the
      patient's perceptions of pain, stiffness and functional improvements. At Visit 3 participants
      would also complete a questionnaire regarding the frequency of knee stretching exercise
      completed and how easy/difficult it had been to achieve. On completing 8 weeks standard
      treatment patients in the comparative group who were deemed eligibility by their Clinician
      would be offered the STAK Tool 8 week treatment.

      Visits would then be completed as per the intervention group minus the interviews.

      An in-depth semi-structured interview (interview 2) will be conducted with participants in
      the intervention group exploring their thoughts and experiences of using the STAK Tool to
      increase their knee flexion, their perceived progress and acceptability of the device.

      A follow up meeting (Visit 4) would take place at 6 months after Visit 3, this would take
      place at the participant's home patients KROM, WOMAC and OKS would be recorded to provide
      data relating to participants long term outcomes.
    

Intervention name(s): STAK Tool; Standard treatment
Intervention type(s): Device; Other
Intervention description(s): Medical stretching device; Physiotherapists tailor treatment of arthrofibrosis to meet their patients' individual needs. Treatment may comprise the following: education, advice and a range of stretching exercises/techniques to change the length and density of the adhesions and shortened tissue. These include active range of movement (AROM), passive range of movement (PROM), strengthening exercises, hands-on high intensity passive physiological stretches, joint mobilisations and a home exercise programme involving full weight bearing exercises with the aim of enabling the patient to regain AROM and function
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment