Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12615000611527
Ethics application status
Approved
Date submitted
8/05/2014
Date registered
12/06/2015
Date last updated
14/06/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Review of manipulation under anaesthesia post total knee replacement with a view of redefining a lower threshold algorithm
Scientific title
In patients with stiffness post total knee replacement, a new algorithm for determining a lower threshold for acceptable range of movement trialled assessing range of movement, time to achieve range of movement, pain, function and patient outcomes scores.
Secondary ID [1] 284569 0
Nil
Universal Trial Number (UTN)
U1111-1156-6105
Trial acronym
MUA algorithm for TKR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stiffness post Total Knee Arthroplasty
Manipulation under Anaesthesia
 291843 0
Condition category
Condition code
Musculoskeletal 292206 292206 0 0
Osteoarthritis
Surgery 292231 292231 0 0
Other surgery
Physical Medicine / Rehabilitation 292232 292232 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will assessed 5-6 week post total knee replacement and those who have a flexion range less than or equal to "'pre-operative flexion'- 20 degrees" will be included into the study.

The patients that fit in this group will be randomised into a manipulation or no- manipulation group and we will review the natural progression of their range and function.

The intervention group will undergo manipulation under anaesthesia. This entails an anaesthetic in a surgical theatre environment and, once anaesthetised, the patients will have their affected knee flexed and extended by the surgeon to achieve better range of movement by tearing through scar tissue that has developed since their total knee replacement. The surgery should only take 30 mins.

The choice of anaesthetic used will be decided by the anaesthetist and the surgeon. It usually includes
a sedation agent and mild muscle relaxant.

Post-op, they will then undergo physiotherapy as inpatients and on discharge.
Intervention code [1] 289340 0
Treatment: Surgery
Comparator / control treatment
The no- manipulation group will be treated as they would be currently- continued aggressive physiotherapy and review. Range of movement and patient reported outcome measures related to pain and function will be collected and reviewed as will the intervention group.

If their range, function and pain deteriorates significantly on review, then they will be offered a manipulation as per current standard treatment protocols.
Control group
Active

Outcomes
Primary outcome [1] 292077 0
Range of movement of the knee expressed in degrees. This will be assessed by the researchers by using a goniometer.
Timepoint [1] 292077 0
At 6 weeks post intervention, 6 months and 12 months.
Primary outcome [2] 292078 0
KOOS score
Timepoint [2] 292078 0
At 6 weeks post intervention, 6 months and 12 months.
Primary outcome [3] 292079 0
Oxford Knee Score
Timepoint [3] 292079 0
At 6 weeks post intervention, 6 months and 12 months.
Secondary outcome [1] 315174 0
Forgotten Joint Score
Timepoint [1] 315174 0
At 6 weeks post intervention, 6 months and 12 months.

Eligibility
Key inclusion criteria
Patients selected for participation will be primary TKR patients that fall between 90 degrees and the minimum redefined range.
This range will be calcuted by (pre-op flexion-20) expressed in degrees
They must be well and fit for the second smaller anaesthetic
Minimum age
45 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Flexion similar to pre-operative range
Flexion less than 90 degrees
Unfit for second anaesthetic

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Potential participants will be identified during follow up post total knee replacements with participating orthopaedic surgeons.

Participants will be give a verbal and written explanation of the trial and written informed consent will be obtained.

Central research admin will then be contacted via phone or in person at central research administration site and
participants will be randomised by computer to the intervention and control groups to ensure allocation concealment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation via online random number generator.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/04/2015
Actual
2/04/2015
Date of last participant enrolment
Anticipated
Actual
30/06/2017
Date of last data collection
Anticipated
Actual
1/08/2017
Sample size
Target
40
Accrual to date
Final
4
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 2446 0
Mater Hospital Pimlico - Pimlico
Recruitment postcode(s) [1] 8064 0
4812 - Pimlico

Funding & Sponsors
Funding source category [1] 289200 0
Charities/Societies/Foundations
Name [1] 289200 0
Orthopaedic Research Institute of Queensland
Country [1] 289200 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Orthopaedic Research Institute of Queensland
Address
Suite 3
Level 2 Mater Medical Centre
21-37 Fulham Road
Pimlico QLD 4812
Country
Australia
Secondary sponsor category [1] 287873 0
None
Name [1] 287873 0
Address [1] 287873 0
Country [1] 287873 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290975 0
Mater Health Services North Queensland Ltd
Ethics committee address [1] 290975 0
21-37 Fulham Road
Pimlico QLD 4812
Ethics committee country [1] 290975 0
Australia
Date submitted for ethics approval [1] 290975 0
14/08/2014
Approval date [1] 290975 0
01/10/2014
Ethics approval number [1] 290975 0
MHS20140812-01
Ethics committee name [2] 292615 0
Mater Human Research Ethics Committee
Ethics committee address [2] 292615 0
Locked Bag 1000
AitkenVale BC QLD 4812
Ethics committee country [2] 292615 0
Australia
Date submitted for ethics approval [2] 292615 0
Approval date [2] 292615 0
14/08/2014
Ethics approval number [2] 292615 0
MHS20140812-01

Summary
Brief summary
Stiffness post Total Knee Replacement (TKR) can cause quite significant disability in patients and is associated with persistent pain and inability to perform activities of daily living. Stiffness post TKR has been reported between
8 to 25 percent.
The standard management for stiffness is aggressive physiotherapy followed by manipulation under anaesthesia
(MUA) predominantly when patients' flexion range of movement (ROM) is restricted to less than or equal to 90degrees. MUA entails forced flexion and extension of the knee under anaesthesia to break the scar tissue causing stiffness, resulting in significant acute improvement usually around 5 to 6 weeks post primary total knee replacement.
We propose decreasing that threshold of acceptable range of movement post total knee replacement in patients whom would otherwise deal with the restrictions and would not qualify for MUA under current guidelines.

Patients will assessed 5-6 week post total knee replacement and those who have a flexion range less than or equal to "'pre-operative flexion' minus 20 degrees" will be included into the study.

Patients selected for participation will be primary TKR patients that fall between 90 degrees and the "new range".
Participants meeting selection criteria will be randomised into one of two groups; either 'intervention' or 'control' groups Results analysis will focus on range of movement and patient reported outcomes.
We intend to follow up patients and record data for a period of 12 months. This will ensure capture of patients that
require late manipulation for worsening function, depicted by manual assessment, patient outcome scores and
other complications.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 48218 0
Dr Peter McEwen
Address 48218 0
Orthopaedic Research Institute of Queensland
Suite 3
Level 2 Mater Medical Centre
21-37 Fulham Road
Pimlico QLD 4812
Country 48218 0
Australia
Phone 48218 0
+61 7 4775 0564
Fax 48218 0
Email 48218 0
[email protected]
Contact person for public queries
Name 48219 0
Mrs Andrea Grant
Address 48219 0
Orthopaedic Research Institute of Queensland
Suite 3
Level 2 Mater Medical Centre
21-37 Fulham Road
Pimlico QLD 4812
Country 48219 0
Australia
Phone 48219 0
+61 7 4775 0564
Fax 48219 0
Email 48219 0
[email protected]
Contact person for scientific queries
Name 48220 0
Dr Peter McEwen
Address 48220 0
Orthopaedic Research Institute of Queensland
Suite 3
Level 2 Mater Medical Centre
21-37 Fulham Road
Pimlico QLD 4812
Country 48220 0
Australia
Phone 48220 0
+61 7 4775 0564
Fax 48220 0
Email 48220 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.