Physiotherapy for Arthrofibrosis Following Knee Replacement.

Fibrosis Clinical Trial

— ReSTART  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05459259
• Other study ID #: 22027
• Status: Recruiting
• Start date: October 3, 2022
• Est. completion date: August 30, 2023

Study information

• Verified date: November 2022
• Source: University of Nottingham
• Contact: Michelle C Hall, PhD
• Phone: 0115 8231794
• Email: michelle.hall[@]nottingham.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 145
• Est. completion date: August 30, 2023
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthroplasty Complications
• Contracture
• Fibrosis

Intervention

Other:
• Interviews and Delphi Survey
no intervention delivered

Locations

Country	Name	City	State
United Kingdom	University of Nottingham	Nottingham

Sponsors (3)

Lead Sponsor	Collaborator
University of Nottingham	King's College London, National Institute for Health Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Qualitative interviews with Patients and Healthcare Professionals	we 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.	12 months
Primary	A Delphi survey with HCPs and patients to achieve consensus agreement on the most important components of an optimal intervention.	We 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 .	6 months