Physiotherapy for Arthrofibrosis Following Knee Replacement.

NCT05459259 | Unknown

• 1 other identifier: 22027
• Study Type: observational
• Target: 145
• Locations: 1 country
• Sites: 1

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. 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. 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. 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. 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

Conditions

Arthroplasty Complications; Fibrosis; Knee Joint Contracture

Keywords

knee stiffness

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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

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

Interventions

Interviews and Delphi Survey OTHER

no intervention delivered

Healthcare Professionals; Patients participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nottingham: lead
• King's College London: collaborator
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (1)

University of Nottingham

Nottingham, NG7 UH, United Kingdom

RECRUITING

Related Publications (1)

• Moffatt F, Narayanasamy M, Smith B, Stock J, Sheehan K, Sackley C, Hall M. "My bloody leg" - The lived experience of arthrofibrosis after total knee arthroplasty. Physiotherapy. 2025 Oct 28;130:101862. doi: 10.1016/j.physio.2025.101862. Online ahead of print.

  PMID: 41273943 DERIVED

MeSH Terms

Conditions

Fibrosis

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Michelle C Hall, PhD

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michelle C Hall, PhD

CONTACT

0115 8231794; michelle.hall@nottingham.ac.uk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2022
• First Posted: July 14, 2022
• Study Start: October 3, 2022
• Primary Completion: August 30, 2023
• Study Completion: August 30, 2023
• Last Updated: November 18, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)