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Physiotherapy for Arthrofibrosis Following Knee Replacement.

Development of an Optimal Physiotherapy Intervention for Arthrofibrosis Following Total Knee Replacement. ReSTART Study (Reducing Stiffness After Knee Replacement)

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05459259
Acronym
ReSTART
Enrollment
145
Registered
2022-07-14
Start date
2022-10-03
Completion date
2023-08-30
Last updated
2022-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthroplasty Complications, Fibrosis, Knee Joint Contracture

Keywords

knee stiffness

Brief summary

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

Interventions

OTHERInterviews and Delphi Survey

no intervention delivered

Sponsors

King's College London
CollaboratorOTHER
National Institute for Health Research, United Kingdom
CollaboratorOTHER_GOV
University of Nottingham
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

for Patients: * 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.

Design outcomes

Primary

MeasureTime frameDescription
Qualitative interviews with Patients and Healthcare Professionals12 monthswe will conduct qualitative interviews with patients to explore (i) the experiences, important outcomes and unmet needs of patients; and with health care professionals (HCPs) to understand (ii) their experiences, perceptions and context of managing arthrofibrosis and (iii) their opinions on the intervention components identified in a systematic review of the evidence.
A Delphi survey with HCPs and patients to achieve consensus agreement on the most important components of an optimal intervention.6 monthsWe will conduct a modified Delphi exercise with a maximum of 4 rounds to agree consensus on (i) the essential components of the intervention and what are the important outcomes that should be collected for patients with arthrofibrosis .

Countries

United Kingdom

Contacts

Primary ContactMichelle C Hall, PhD
michelle.hall@nottingham.ac.uk0115 8231794

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026