Use of the STAK Tool in treatment of arthrofibrosis post TKR
Research type
Research Study
Full title
A feasibility study considering the use of the STAK Tool in addition to standard physiotherapy compared to standard physiotherapy alone to treat arthrofibrosis patients following total knee replacement.
IRAS ID
224822
Contact name
Steven Godsiff
Contact email
Sponsor organisation
University Hospitals of Leicester
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Summary of Research
A frequent complication following total knee replacement (TKR) is arthrofibrosis, a severe stiffening of the knee caused by scar tissue, resulting in a lack of crucial range of movement. Conventional physiotherapy treatment includes high intensity stretching (HIS) to enable the patient to improve functional knee flexion. Pain and stiffness can limit progress resulting in more physiotherapy sessions and potential surgery to restore knee flexion. \nMedical stretching devices are currently being used in the USA to improve knee flexion active range of movement (KROM). The STAK is a medical stretching device designed jointly by a physiotherapist (Sara Aspinall) and a patient. A key advantage is it is safe as the user has control of their pain threshold. \nThe aims of this feasibility study are to 1) record the effect that the STAK has on KROM, 2) explore patients’ experiences of using the STAK Tool, 3) Consider outcome measures and establish an intervention procedure and research design to inform a definitive trial that will determine the effectiveness of the STAK Tool in the treatment of patients suffering with arthrofibrosis following TKR.\nPatients who have restricted KROM (less than 70˚ flexion) or are identified by their Clinicians as requiring further intensive physiotherapy to address their stiffness would be approached to take part in this study at their post op follow up appointment in the Orthopaedic Clinic (approximately 8 weeks post TKR). \nThis study would investigate patients’ short and longer term progress after total knee replacement following 8 weeks use of the STAK Tool at home plus standard physiotherapy treatment (intervention group), compared to patients receiving physiotherapy treatment alone (comparative group).\nAngle of knee flexion would be measured (standardised method) by the Principal Investigator and 2 questionnaires completed exploring patient’s perceptions of pain, stiffness and functional improvements prior to the 8 weeks treatment period, following it and 6 months later. Two semi-structured interviews would be conducted with the intervention group to explore patients’ thoughts and experiences of using the STAK Tool in their treatment programme.Summary of Results
Compared to the control standard physiotherapy group, the STAK intervention group made significant gains in mean range of movement (ROM) (30° versus 8°, p < 0.0005), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) (19 points versus 3, p < 0.0005), and Oxford knee score (OKS) (8 points versus 3, p < 0.0005). The improvements in the STAK group were maintained at long-term follow-up. No patients suffered any complications relating to the STAK, and 96% of patients found the STAK tool ‘perfectly acceptable’.The STAK tool is effective in increasing ROM and reducing pain and stiffness. Patients find it acceptable and adherence to treatment was high. This study indicates that the STAK tool would be of benefit in clinical practice and may offer a new, cost-effective treatment for arthrofibrosis
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
17/WM/0219
Date of REC Opinion
18 Jul 2017
REC opinion
Further Information Favourable Opinion