Arthroplasty ComplicationsReSTARTNCT05459259
Physiotherapy for Arthrofibrosis Following Knee Replacement.
An observational study of Arthroplasty Complications and Fibrosis, run by University of Nottingham at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty Complications, Fibrosis, Knee Joint Contracture
- What is being tested?
- Interviews and Delphi Survey
- How many people
- 145 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Oct 2022to 30 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have had problematic stiffness following knee arthroplasty and healthcare professionals who manage patients with those conditions.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Nottingham
Nottingham, NG7 UH
Michelle C Hall, PhD, michelle.hall@notitngham.ac.uk
Catherine Sackley, PhD, catherine.sackley@nottingham.ac.uk
About this study
Official title: 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:
- 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.
- 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.
- 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.
- 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
- Being tested
- Interviews and Delphi Survey
- Keywords
- knee stiffness
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interviews and Delphi SurveyOther
no intervention delivered
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: Interviews and Delphi Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 .
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start3 Oct 2022
- Primary completion30 Aug 2023 (estimated)
- Study completion30 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arthroplasty ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 145 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London, National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Michelle C Hall, PhD, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05459259
- Sponsor's protocol ID
- 22027
- Acronym
- ReSTART
- Status last verified
- Nov 2022
- First submitted
- 11 Jul 2022
- Last updated
- 18 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moffatt F, Narayanasamy M, Smith B, Stocks J, Sheehan K, Sackley C, Hall M. "My bloody leg" - The lived experience of arthrofibrosis after total knee arthroplasty. Physiotherapy. 2026 Mar;130:101862. doi: 10.1016/j.physio.2025.101862. Epub 2025 Oct 28.
PubMed 41273943
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an Optimal Physiotherapy Intervention for Arthrofibrosis Following Total Knee Replacement. ReSTART Study (Reducing Stiffness After Knee Replacement)
- ClinicalTrials.gov ID
- NCT05459259
- Acronym / sponsor ID
- ReSTART / 22027
- Conditions
- Arthroplasty Complications, Fibrosis, Knee Joint Contracture
- Keywords
- knee stiffness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 145 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- King's College London, National Institute for Health Research, United Kingdom
- Study start
- 3 Oct 2022 (actual)
- Primary completion
- 30 Aug 2023 (estimated)
- Study completion
- 30 Aug 2023 (estimated)
- First posted
- 14 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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.
- 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 design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients participants | – | Other: Interviews and Delphi SurveyAdults 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. |
| Healthcare Professionals | – | Other: Interviews and Delphi SurveyPhysiotherapists/Occupational Therapist/ Nurses and Orthopedic surgeons with clinical experience in the management of patients with arthrofibrosis following knee joint arthroplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have had problematic stiffness following knee arthroplasty and healthcare professionals who manage patients with those conditions.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- Patients with neurological or blood disorders
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interviews and Delphi Surveyno intervention delivered | Other | Healthcare Professionals, Patients participants |
Primary outcome
Qualitative interviews with Patients and Healthcare Professionals
Time frame: 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.
A Delphi survey with HCPs and patients to achieve consensus agreement on the most important components of an optimal intervention.
Time frame: 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 .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2022.
- Derived from this study: PubMed 41273943Moffatt F, Narayanasamy M, Smith B, Stocks J, Sheehan K, Sackley C, Hall M. "My bloody leg" - The lived experience of arthrofibrosis after total knee arthroplasty. Physiotherapy. 2026 Mar;130:101862. doi: 10.1016/j.physio.2025.101862. Epub 2025 Oct 28.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle C Hall, PhD principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthroplasty Complications and Fibrosis, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michelle C Hall, PhD (0115 8231794, michelle.hall@nottingham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative interviews with Patients and Healthcare Professionals (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05459259, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2022.