Physiotherapy for Arthrofibrosis Following Knee Replacement.

NCT ID: NCT05459259

Last Updated: 2022-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

145 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-03

Study Completion Date

2023-08-30

Brief Summary

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This research aims to develop an optimal physiotherapy intervention for people with arthrofibrosis (stiffness due to scar tissue) after total knee replacement (TKR). We will develop an optimal intervention by conducting:

1. A review of the evidence to identify what components could be included in the intervention, how effective they are and what outcomes have been measured by the research.
2. Interviews with patients with arthrofibrosis to understand the impact it has on their life and what outcomes are important to them and interviews with healthcare professionals (HCPs) to understand their experiences of treating patients with arthrofibrosis.
3. A Delphi study with a larger group of HCPs and patients to reach a consensus on what the optimal intervention should include. This involves a series of anonymous voting on a range of items that have been generated by the group and the results of the evidence review.
4. A workshop with patients, HCPs and health-care commissioners to finalise the intervention. During the workshop we will present our findings and work in small groups to agree the intervention

Detailed Description

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Conditions

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Fibrosis Knee Joint Contracture Arthroplasty Complications

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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Patients participants

Adults who have undergone elective knee arthroplasty with post-operative arthrofibrosis/stiffness who have undergone MUA in the previous 24 months or are currently listed for a MUA.

Interviews and Delphi Survey

Intervention Type OTHER

no intervention delivered

Healthcare Professionals

Physiotherapists/Occupational Therapist/ Nurses and Orthopedic surgeons with clinical experience in the management of patients with arthrofibrosis following knee joint arthroplasty

Interviews and Delphi Survey

Intervention Type OTHER

no intervention delivered

Interventions

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Interviews and Delphi Survey

no intervention delivered

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* adults (aged 18 and over) of any age who have undergone elective TKR with post- operative arthrofibrosis/stiffness who have undergone manipulation under anaesthetic (MUA) in the previous 24 months or are currently listed for a MUA.
* Ability to give informed consent

Exclusion Criteria

* Patients with neurological or blood disorders

For HCP participants :

* at least 5 years of experience working with joint arthroplasty including the management of patients with arthrofibrosis or 3 years in the case of orthopaedic surgeons.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King's College London

OTHER

Sponsor Role collaborator

National Institute for Health Research, United Kingdom

OTHER_GOV

Sponsor Role collaborator

University of Nottingham

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michelle C Hall, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Nottingham

Locations

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University of Nottingham

Nottingham, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Michelle C Hall, PhD

Role: CONTACT

0115 8231794

Facility Contacts

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Michelle C Hall, PhD

Role: primary

Catherine Sackley, PhD

Role: backup

Other Identifiers

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22027

Identifier Type: -

Identifier Source: org_study_id

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