STAK Tool for Treatment of Arthrofibrosis Post Total Knee Replacement

NCT04019847 | Completed DMC

• 1 other identifier: 93160
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Arthrofibrosis

Outcome Measures

Primary Outcomes (2)

• Change in range of knee movement as assessed using a universal goniometer

  Universal goniometer used to measure knee range of movement

  Baseline, 8 weeks after intervention/control, and 6 months after intervention/control

• Change in range of knee movement as assessed using a mobile app.

  A Mobile app used to measure knee range of movement

  Baseline, 8 weeks after intervention/control, and 6 months after intervention/control

Secondary Outcomes (2)

• WOMAC Score (The Western Ontario and McMaster Universities Osteoarthritis Index)

  Baseline, 8 weeks after intervention/control, and 6 months after intervention/control

• Oxford Knee Score (OKS)

  Baseline, 8 weeks after intervention/control, and 6 months after intervention/control

Other Outcomes (3)

• Semi-structured interviews

  Prior to and following use of the STAK Tool for 8 weeks

• Home exercise questionnaire

  Immediately following intervention period.

• Acceptability Questionnaire

  Immediately following STAK Tool intervention period.

Study Arms (2)

STAK Tool

EXPERIMENTAL

The STAK Tool enables patients to apply a high intensity stretch to their knee independently. Patients are asked to do this for a maximum of 60 mins per day.

Device: STAK Tool; Other: Standard treatment

Standard treatment

ACTIVE COMPARATOR

Patients are treated as per their Clinician's prescription. 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 ROM and function.

Other: Standard treatment

Interventions

STAK Tool DEVICE

Medical stretching device

STAK Tool

Standard treatment OTHER

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

STAK Tool; Standard treatment

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• male or female,
• to 95 year olds,
• having received a primary total knee replacement within the last 12 months.
• Following their TKR have less than 70 degrees knee flexion or have been prescribed intensive physiotherapy for their knee stiffness by their Consultant.
• Between 44kg and 159kg.

You may not qualify if:

• post malignancy or knee trauma
• have leaking wounds or infected joints,
• have rheumatoid arthritis or osteoporosis,
• have undergone long term steroid treatment or the clinician felt the patient was at risk of post-operative fracture.
• Fell outside weight limits (44kg to 159kg),
• Unable to give consent themselves (confusion, non-English speaking patients).

Sponsors & Collaborators

• University Hospitals, Leicester: lead

Study Sites (1)

University Hospitals of Leicester NHS Trust

Leicester, LE5 4PW, United Kingdom

Location

Study Officials

• Sara Aspinall, MScR

  University Hospitals, Leicester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 11, 2018
• First Posted: July 15, 2019
• Study Start: August 2, 2017
• Primary Completion: August 19, 2019
• Study Completion: August 19, 2019
• Last Updated: April 28, 2020

Record last verified: 2020-04

Locations

GB (1)