ClinicalTrials.gg
Status unknownNCT05459259ReSTARTUpdated Nov 18, 2022

Physiotherapy for Arthrofibrosis Following Knee Replacement.

An observational study in Arthroplasty Complications, Fibrosis and Knee Joint Contracture, sponsored by University of Nottingham. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-18.

Sponsored by University of Nottingham · Observational

The sponsor has not verified this record recently (last verified Nov 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Other
Enrollment
145
Ages
18 Years and older
Sex
All
01

Study 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
02

Conditions studied

  • Arthroplasty Complications
  • Fibrosis
  • Knee Joint Contracture

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Keywords

  • knee stiffness
03

In context

Fibrosis

1,270 studies on the registry are indexed under Fibrosis; 276 are open to participants now.

This study's planned enrollment of 145 is close to the median of 157 across 386 observational studies indexed under Fibrosis.

Browse Fibrosis studies →

Lead sponsor

University of Nottingham is the lead sponsor of 465 studies on the registry; 80 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Other
Time perspective
Other
Enrollment
145 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • OtherInterviews and Delphi Survey

    no intervention delivered

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12 months

  2. 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 .

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05459259
Collaborators
King's College London, National Institute for Health Research, United Kingdom
Responsible party
Sponsor
First posted
Jul 14, 2022
Start date
Oct 3, 2022
Primary completion
Aug 30, 2023 (estimated)
Completion
Aug 30, 2023 (estimated)
Last update
Nov 18, 2022

Study contacts

Michelle C Hall, PhD
Contact
michelle.hall@nottingham.ac.uk
0115 8231794
Michelle C Hall, PhD
principal investigator · University of Nottingham

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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