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NCT04019847: STAK

STAK Tool for Treatment of Arthrofibrosis Post Total Knee Replacement

Completed NA Last updated 28 April 2020
What this trial tests

NA trial testing STAK Tool in Arthrofibrosis in 35 participants. Completed in 19 August 2019.

Timeline
2 August 2017
Primary endpoint
19 August 2019
19 August 2019

Quick facts

Lead sponsorUniversity Hospitals, Leicester
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designsequential
Maskingsingle
Primary purposetreatment
Enrollment35
Start date2 August 2017
Primary completion19 August 2019
Estimated completion19 August 2019
Sites1 location across United Kingdom

Drugs / interventions tested

Conditions studied

Sponsor

University Hospitals, Leicester

Who can join

Adults 18 to 95, any sex, with Arthrofibrosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. The STAK tool: evaluation of a new device to treat arthrofibrosis and poor range of movement following total knee arthroplasty and major knee surgery.
    Aspinall SK, Wheeler PC, Godsiff SP, Hignett SM, et al · · 2020 · cited 3× · PMID 33215140 · DOI 10.1302/2633-1462.18.bjo-2020-0096

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