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STAK Tool for Treatment of Arthrofibrosis Post Total Knee Replacement

NCT04019847 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2020-04-28

No results posted yet for this study

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

Interventions

DEVICE

STAK Tool

Medical stretching device

OTHER

Standard treatment

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

Sponsors & Collaborators

  • University Hospitals, Leicester

    lead OTHER

Principal Investigators

  • Sara Aspinall, MScR · University Hospitals, Leicester

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-08-02
Primary Completion
2019-08-19
Completion
2019-08-19

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04019847 on ClinicalTrials.gov