Physiotherapy for Arthrofibrosis Following Knee Replacement. (ReSTART)

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

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

Study Overview

• Status: Recruiting
• Conditions: Fibrosis; Arthroplasty Complications; Knee Joint Contracture
• Intervention / Treatment: Other: Interviews and Delphi Survey

• Study Type: Observational
• Enrollment (Anticipated): 145

Contacts and Locations

• Study Contact: Name: Michelle C Hall, PhD; Phone Number: 0115 8231794; Email: michelle.hall@nottingham.ac.uk

Study Locations

• United Kingdom
  • Nottingham, United Kingdom, NG7 UH
    • Recruiting
    • University of Nottingham
    • Contact: Michelle C Hall, PhD; Email: michelle.hall@notitngham.ac.uk
    • Contact: Catherine Sackley, PhD; Email: catherine.sackley@nottingham.ac.uk
    • Principal Investigator: Michelle Hall, PhD
    • Sub-Investigator: Melanie Narayanasamy, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who have had problematic stiffness following knee arthroplasty and healthcare professionals who manage patients with those conditions.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: Interviews and Delphi Survey; 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	Other: Interviews and Delphi Survey; no intervention delivered

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University of Nottingham
• Collaborators: King's College London; National Institute for Health Research, United Kingdom
• Investigators: Principal Investigator: Michelle C Hall, PhD, University of Nottingham

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2022
• Primary Completion (Anticipated): August 30, 2023
• Study Completion (Anticipated): August 30, 2023

Study Registration Dates

• First Submitted: July 11, 2022
• First Submitted That Met QC Criteria: July 11, 2022
• First Posted (Actual): July 14, 2022

Study Record Updates

• Last Update Posted (Actual): November 18, 2022
• Last Update Submitted That Met QC Criteria: November 14, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: knee stiffness
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Contracture
• Other Study ID Numbers: 22027

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No