Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202212516035370 Date of Approval: 11/12/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Early outcome measurement of effectiveness of Continuous passive motion and conventional physical therapy in knee function after retrograde femoral nailing
Official scientific title Comparative analysis of Continuous passive motion and conventional physical therapy in preventing knee stiffness after retrograde femoral nailing
Brief summary describing the background and objectives of the trial Intramedullary has evolved to become the gold standard for diaphyseal femoral fractures. The antegrade been the most commonly used; retrograde femoral nailing is increasingly being used for distal femoral factures, bilateral femoral fractures, ipsilateral pelvic and hip fractures, floating knee and obesity. one of the major drawbacks of retrograde femoral nailing is violation of virgin nail with increased predisposition to knee sepsis, knee pain, and postoperative knee joint stiffness. Postoperative rehabilitation protocol that incorporates active and passive knee motion in the early is desirable to reduce the untoward complications. To achieve this aim, conventional physical therapy (CPT) are instituted early postoperative period either alone or in combination with continuous passive motion (CPM) with varying reported successes. There is no study done comparing the effectiveness of CPT and CPM in knee function after retrograde femoral nailing. This study was done to compare these methods. The objective of this study was to evaluate the effectiveness of CPM compared to conventional physical therapy (CPT) in knee function after retrograde femoral nailing.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Injury, Occupational Diseases, Poisoning,Orthopaedics,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 01/07/2014
Actual trial start date 04/07/2016
Anticipated date of last follow up 30/06/2018
Actual Last follow-up date 24/12/2021
Anticipated target sample size (number of participants) 98
Actual target sample size (number of participants) 88
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Conventional Physical therapy active and passive motion of knee in flexion and extension, hip abduction/ adduction active and Passive motion, 30min for each for a total 2hours duration On the first day after surgery, respiratory and circulatory exercises were commenced. Isometric knee extensor muscle exercises were performed, and extension knee alignment was maintained. Active and passive knee flexion, abduction and adduction of the hip in the horizontal plane were done. This was done every 30minutes for 2 hours. On the second day, walking with the appropriate device was commenced without weight bearing in addition to above exercises. Walking with partial weight bearing device was commenced on day 3 with other activities as highlighted above and this continued till day 7. Each session lasted for 2 hours per day. 44 Active-Treatment of Control Group
Experimental Group Continuous passive motion 2hours CPM device application was mostly done by the second author (O.O) and other doctors in the unit who volunteered for training before the commencement of the study. Teaching sessions were organized, and written and audio-video instructions were provided. Subject’s thigh was measured from Ischial tuberosity to the knee joint line in extension. The thigh arm of the CPM was adjusted accordingly. Subjects were positioned supine in their bed, and the CPM device was placed under the affected limb with the knee slightly flexed (15°). For stability, one strap was attached the subject’s thigh; another strap attached to the subject’s lower leg. CPM was then used for 2 hours continuously, including a 5-minute warm-up period each day until day 7 and after surgery. The second author (OO) did the setting of the CPM machine with a limited ROM (0 to 60 degrees with speed and force set 4) and was increased to the full ROM as healing occurs. Speed and force were gradually increased by 1 per day. Each session lasted for 2 hours. The applications were performed in the evening in order to avoid interfering with all other daytime medical and nursing activities. Patients in this group was commenced on isometric quadriceps exercise day 1, ambulation without weight bearing on day 2 and ambulation with partial weight bearing on day 3 after surgery using appropriate walking device. On POD 8 the ranges of motion of knee of patients in both groups were measured and recorded. This was repeated on POD 14 and POD 42. 44
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Patients with distal one third femoral shaft fractures 2. All patients who had open reduction and internal fixation with retrograde femoral interlocking nail. 3. Patient who gave both verbal and written consent for the study 1. Knee stiffness prior to surgery. 2. Multiply injured patients (moderate to severe head injury and thoraco-abdominal injuries) 3. Associated knee dislocation 4. Patient with diabetes mellitus or any other form of immunosuppressive diseases 5. Mental disability 6. Open fractures (Gustillo-Andersen type 111B and C) 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 90 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 01/04/2014 Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Federal Medical Centre, No 1 Adekunle Ajasin street, Owo 31111 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Knee joint stiffness defined as those who total arc motion at knee is less than or equal to 90 degrees week 1, 2 , and 6.
Primary Outcome Postoperative knee pain using the visual analog scale VAS days 1, 2, 3, 4, 5, 6, and 7.
Secondary Outcome total range of motion measured as the total arc of the motion from full extension to maximum flexion weeks 1, 2, and 6.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Federal Medical Centre no 1 Adekunle Ajasin street, Owo 31111 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr. Olusegun Olisa No 1 Adekunle Ajasin Street Owo Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr. Olusegun Olisa Department of Orthopaedic Surgery, Federal Medical Centre, No 1Adekunle Ajasin Street Owo Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Dr. Anthony Ayotunde Olasinde Dept. of Orthopaedic Surgery and Traumatology, Federal Medical Centre, No1 Adekunle Ajasin Street, Owo Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Olusegun Olisa olisasegun@gmail.co +2348062733611 Department of Orthopaedic Surgery and Traumatology, FMC, No 1 Adekunle Ajasin Street,
City Postal code Country Position/Affiliation
Owo Nigeria Consultant Orthopaedic Surgeon
Role Name Email Phone Street address
Scientific Enquiries Anthony Olasinde tonyolasinde@kiu.ac.ug +256751401847 kampala International University Western Campus,
City Postal code Country Position/Affiliation
Ishaka Bushenyi Uganda Senior Lecturer
Role Name Email Phone Street address
Public Enquiries Kehinde Oluwadiya oluwadiya@gmail.com +2348035029563 College of Medicine Ekiti State University,
City Postal code Country Position/Affiliation
Ado Ekiti Nigeria Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data requests can be submitted starting 1 year after article publication and data will be made accessible for up to 24 months. Extension may be granted on case to case baiss Statistical Analysis Plan,Study Protocol 24month controlled
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://osf.io/ga8jt/?view_only=db7ea9bd614d4724bbaac933714bc8dd Yes 09/12/2022
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 09/12/2022
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information