ReSTART: Physiotherapy for Arthrofibrosis Following Knee Replacement.

Sponsor
University of Nottingham (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05459259
Collaborator
King's College London (Other), National Institute for Health Research, United Kingdom (Other)
145
12.9

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Other: Interviews and Delphi Survey

Study Design

Study Type:
Observational
Anticipated Enrollment :
145 participants
Observational Model:
Other
Time Perspective:
Other
Official Title:
Development of an Optimal Physiotherapy Intervention for Arthrofibrosis Following Total Knee Replacement. ReSTART Study (Reducing Stiffness After Knee Replacement)
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Aug 30, 2023
Anticipated Study Completion Date :
Aug 30, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Qualitative interviews with Patients and Healthcare Professionals [12 months]

    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.

  2. A Delphi survey with HCPs and patients to achieve consensus agreement on the most important components of an optimal intervention. [6 months]

    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 .

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Michelle C Hall, PhD, University of Nottingham

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Nottingham
ClinicalTrials.gov Identifier:
NCT05459259
Other Study ID Numbers:
  • 22027
First Posted:
Jul 14, 2022
Last Update Posted:
Jul 14, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Nottingham
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 14, 2022