KneeNCT04694625
Structured Rehabilitation Program for Patients With Total Knee Replacement
A study testing Structured Rehabilitation Program and Conventional Physical Therapy in people with Knee, run by Riphah International University at 1 site in Pakistan.
Trial summary
This study will be a randomized controlled trial. This study will be conducted in Horizon Hospital Lahore. A sample size of 26 patients will be taken. Patients will be divided into two groups by lottery method. Read more about this study
- Who is it for?
- Ages 50 to 65 years
- Conditions the study is for
- Knee
- What is being tested?
- Structured Rehabilitation Program and Conventional Physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Jan 2021to 20 Jul 2021
- Phase
- Interventional
- 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 50 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with unilateral or bilateral total knee replacement through medial parapatellar approach.
Who cannot join
- Patients awaiting revision TKR
- Post traumatic patients planned for TKR
- Those with non-degenerative joint diseases
- Patients got infected after operation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Structured Rehabilitation Program on Pain and Function in Patients With Total Knee Replacement
This study will be a randomized controlled trial. This study will be conducted in Horizon Hospital Lahore. A sample size of 26 patients will be taken. Patients will be divided into two groups by lottery method. Group A will be treated with Structured Rehabilitation program along with conventional physiotherapy while Group B will be treated with conventional physiotherapy only. Both groups will receive treatment for 4 weeks,3 sessions per week. The outcome measures Numeric pain rating scale(NPRS),6 minutes' walk test and Womac scale will be measured at baseline and at the end of 4th week. Data will be analyzed by SPSS 25.
Read the detailed description
Total knee replacement (TKR) is the most common, gold standard surgical intervention in relieving pain, improving physical functions and quality of life in end-stage osteoarthritis.An estimated 25-47% of patients who are eligible for primary joint replacement in the United Kingdom have isolated unicompartmental osteoarthritis, and would be eligible to receive either implant.
Adequate post-operative pain control in TKR patients is very important as inadequate pain control can lead to delayed mobilization, prolonged hospital stay, deep vein thrombosis with embolic events, increased psychological stress thereby increasing morbidity and mortality of TKR patients.Physiotherapy, principally exercise prescription and gait re- education, is advocated for people after THR and TKR.Surgeons are particularly concerned regarding cementless implants, given they rely on press fit fixation in the surrounding bone for primary stability.Patients undergoing total knee arthroplasty often have unfulfilled expectations from the surgery that can lead to dissatisfaction.Patients have a poor understanding of outcomes related to total knee replacement (TKR) surgery, with most patients underestimating the potential benefits and overestimating the risk of complications.To prevent chronic pain after TKR, several perioperative interventions show benefits and merit further research. Enhanced Recovery After Surgery (ERAS) has been successfully adopted across a range of procedures with using rehabilitation program. This study will focus on effects of structured rehabilitation program of 4 weeks with different goals in each week for reducing pain and improving function in patients with knee osteoarthritis. Study will provide a structured rehabilitation program for the physiotherapist to achieve all goals in three phases (protective, Recovery \& Activity phase).
AP Antony-Leo 2019 in this RCT study improvements occurred by following structured rehabilitation care,quality of life and joint specific outcomes through medial parapatellear approach.Andrew David Beswick. In TKR to prevent chronic pain, showing benefits by using several perioperative interventions.In this systematic review the patients with osteoarthritis achieve long term outcomes after TKR by using perioperative interventions. In evidence base review enhanced recovery after surgery had already been used successfully in various surgical specialities. This evidence-based review provides an insight into the best evidence linked to each component and their rationale for inclusion in the proposed enhanced recovery after surgery protocol. Arijit Goshi 2019. In this evidence base review enhanced recovery programmes require a multidisciplinary team of dedicated professionals, principally involving preoperative education, multimodal pain control and accelerated rehabilitation; this will be enhanced if combined with minimally invasive surgery. The current economic environment and restricted healthcare budget further necessitate brief hospitalisation while minimising costs.MS Ibrahim 2019.C.E.H Scott 2019. The patient satisfaction rate of 81.4 % at 12 month in this study is comparable to other studies.In this prospective study it is important to clear that whether dissatisfaction is a consequence of surgical technique, implant design, patient selection, or counselling and the management of expectation. This study provided knowledge about to help patient selection and counselling. Soren T.Sku 2019 in an RCT study in patients with knee osteoarthritis who were eligible for total knee replacement, treatment with total knee replacement followed by nonsurgical treatment resulted in greater pain relief and functional improvement after 12 month as compared to nonsurgical treatment.Literature shows that postoperative rehabilitation for total knee replacement is of prime importance and improves postoperative outcomes and it would be more beneficial to divide outcome goals in phases so as to achieve these goals according to week wise distribution
- Conditions
- Knee
- Being tested
- Structured Rehabilitation Program, Conventional Physical Therapy
- Keywords
- Knee pain, knee Replacement, Degenerative knee disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Rehabilitation ProgramOther
Early Function Phase (Protective phase) week 1 Progressive Function Phase (Recovery Phase) 2nd and 3rd week Advance Function Phase (Activity Phase) 4th week
Conventional Physical TherapyOther
- Rapid post-operative mobilization • Range of motion exercises started • Passive extension by placing pillow under foot • Flexion-by dangling the leg over the side of bed • Muscle strengthening exercises • Weight bearing is allowed on 1st post-operative
| Study group | Role | What they receive |
|---|---|---|
| Structured rehabilitation program | Experimental | Structured rehabilitation program \& conventional physical therapy Receives: Other: Structured Rehabilitation Program; Other: Conventional Physical Therapy |
| conventional physical therapy | Active comparator | conventional physical therapy Receives: Other: Conventional Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale (NPRS)
NPRS is a segmented version of Visual Analogue Scale (VAS). It consists of number from 0 to 10. Patient selects a number that best reflects his/her pain intensity where 0 is no pain and 10 is maximum pain. For construct validity, NPRS was highly correlated to Visual Analogue Scale (VAS) (0.86-0.95). The test-retest reliability of this scale is recorded to be 0.96. (Hawker et al. 2011)
Measured: 4th week
6 Minute walk test
The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6-minute walk distance (6 MWD) provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise.
The 6 MWT provides information regarding functional capacity, response to therapy and prognosis across a broad range of chronic cardiopulmonary conditions. Main strengths of the 6 MWT stem from its simplicity in concept and performance, low cost, ease of standardization, and acceptance by test subjects, including those who are deconditioned, elderly, or frail.
Measured: 4th week
WOMAC SCALE
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. The WOMAC measures five items for pain (score range 0- 20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68).[2] Physical functioning questions cover everyday activities such as stair use, standing up from a sitting or lying position, standing, bending, walking, getting in and out of a car, shopping, putting on or taking off socks, lying in bed, getting in or out of a bath, sitting, and heavy and light household duties.
Measured: 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start10 Jan 2021
- Primary completion10 Jul 2021
- Study completion20 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for KneeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saima Zahid, PhD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04694625
- Sponsor's protocol ID
- REC/Lhr/20/1041/M. Arsalan
- Status last verified
- Aug 2021
- First submitted
- 3 Jan 2021
- Last updated
- 24 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Antony-Leo AP, Arun-Maiya G, Mohan-Kumar M, Vijayaraghavan PV. Structured Total Knee Replacement Rehabilitation Programme and Quality of Life following Two Different Surgical Approaches - A Randomised Controlled Trial. Malays Orthop J. 2019 Jul;13(2):20-27. doi: 10.5704/MOJ.1907.004.
PubMed 31467647Willis-Owen CA, Brust K, Alsop H, Miraldo M, Cobb JP. Unicondylar knee arthroplasty in the UK National Health Service: an analysis of candidacy, outcome and cost efficacy. Knee. 2009 Dec;16(6):473-8. doi: 10.1016/j.knee.2009.04.006. Epub 2009 May 22.
PubMed 19464898Nussenzveig TC. Pain management after total joint replacement and its impact on patient outcomes. AORN J. 1999 Dec;70(6):1060-2. doi: 10.1016/s0001-2092(06)62213-8. No abstract available.
PubMed 10635429Skrejborg P, Petersen KK, Beck J, Ulrich M, Simonsen O, Nielsen PT, Arendt-Nielsen L, Laursen M. Investigating the Effect of Perioperative Chlorzoxazone on Acute Postoperative Pain After Total Hip and Knee Replacement Surgery. Clin J Pain. 2020 May;36(5):352-358. doi: 10.1097/AJP.0000000000000805.
PubMed 31977370Mohammad HR, Kennedy JA, Mellon SJ, Judge A, Dodd CA, Murray DW. The clinical outcomes of cementless unicompartmental knee replacement in patients with reduced bone mineral density. J Orthop Surg Res. 2020 Jan 31;15(1):35. doi: 10.1186/s13018-020-1566-2.
PubMed 32005197Levinger P, Bartlett JR, Bergman NR, McMahon S, Menz HB, Hill KD. The discrepancy between patient expectations and actual outcome reduces at the first 6 months following total knee replacement surgery. Knee Surg Sports Traumatol Arthrosc. 2019 Jul;27(7):2042-2050. doi: 10.1007/s00167-018-5210-1. Epub 2018 Oct 8.
PubMed 30298413Fraenkel L, Benjamin Nowell W, Stake CE, Venkatachalam S, Eyler R, Michel G, Peters E. Impact of Information Presentation Format on Preference for Total Knee Replacement Surgery. Arthritis Care Res (Hoboken). 2019 Mar;71(3):379-384. doi: 10.1002/acr.23605.
PubMed 29799668Beswick AD, Dennis J, Gooberman-Hill R, Blom AW, Wylde V. Are perioperative interventions effective in preventing chronic pain after primary total knee replacement? A systematic review. BMJ Open. 2019 Sep 6;9(9):e028093. doi: 10.1136/bmjopen-2018-028093.
PubMed 31494601Wainwright TW, Immins T, Antonis JHA, Taylor H, Middleton RG. Can the introduction of Enhanced Recovery After Surgery (ERAS) reduce the variation in length of stay after total ankle replacement surgery? Foot Ankle Surg. 2019 Jun;25(3):294-297. doi: 10.1016/j.fas.2017.12.005. Epub 2017 Dec 21.
PubMed 29409177Ghosh A, Chatterji U. An evidence-based review of enhanced recovery after surgery in total knee replacement surgery. J Perioper Pract. 2019 Sep;29(9):281-290. doi: 10.1177/1750458918791121. Epub 2018 Sep 13. No abstract available.
PubMed 30212288Ibrahim MS, Alazzawi S, Nizam I, Haddad FS. An evidence-based review of enhanced recovery interventions in knee replacement surgery. Ann R Coll Surg Engl. 2013 Sep;95(6):386-9. doi: 10.1308/003588413X13629960046435.
PubMed 24025284Scott CE, Howie CR, MacDonald D, Biant LC. Predicting dissatisfaction following total knee replacement: a prospective study of 1217 patients. J Bone Joint Surg Br. 2010 Sep;92(9):1253-8. doi: 10.1302/0301-620X.92B9.24394.
PubMed 20798443Skou ST, Roos EM, Laursen MB, Rathleff MS, Arendt-Nielsen L, Simonsen O, Rasmussen S. A Randomized, Controlled Trial of Total Knee Replacement. N Engl J Med. 2015 Oct 22;373(17):1597-606. doi: 10.1056/NEJMoa1505467.
PubMed 26488691Bade MJ, Struessel T, Dayton M, Foran J, Kim RH, Miner T, Wolfe P, Kohrt WM, Dennis D, Stevens-Lapsley JE. Early High-Intensity Versus Low-Intensity Rehabilitation After Total Knee Arthroplasty: A Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2017 Sep;69(9):1360-1368. doi: 10.1002/acr.23139. Epub 2017 Aug 13.
PubMed 27813347Barker KL, Beard D, Price A, Toye F, Underwood M, Drummond A, Collins G, Dutton S, Campbell H, Kenealy N, Room J, Lamb SE. COmmunity-based Rehabilitation after Knee Arthroplasty (CORKA): study protocol for a randomised controlled trial. Trials. 2016 Oct 13;17(1):501. doi: 10.1186/s13063-016-1629-1.
PubMed 27737685
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Structured Rehabilitation Program on Pain and Function in Patients With Total Knee Replacement
- ClinicalTrials.gov ID
- NCT04694625
- Acronym / sponsor ID
- REC/Lhr/20/1041/M. Arsalan
- Conditions
- Knee
- Keywords
- Knee pain, knee Replacement, Degenerative knee disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 10 Jan 2021 (actual)
- Primary completion
- 10 Jul 2021 (actual)
- Study completion
- 20 Jul 2021 (actual)
- First posted
- 5 Jan 2021 (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 study will be a randomized controlled trial. This study will be conducted in Horizon Hospital Lahore. A sample size of 26 patients will be taken. Patients will be divided into two groups by lottery method. Group A will be treated with Structured Rehabilitation program along with conventional physiotherapy while Group B will be treated with conventional physiotherapy only. Both groups will receive treatment for 4 weeks,3 sessions per week. The outcome measures Numeric pain rating scale(NPRS),6 minutes' walk test and Womac scale will be measured at baseline and at the end of 4th week. Data will be analyzed by SPSS 25.
Detailed description
Total knee replacement (TKR) is the most common, gold standard surgical intervention in relieving pain, improving physical functions and quality of life in end-stage osteoarthritis.An estimated 25-47% of patients who are eligible for primary joint replacement in the United Kingdom have isolated unicompartmental osteoarthritis, and would be eligible to receive either implant.
Adequate post-operative pain control in TKR patients is very important as inadequate pain control can lead to delayed mobilization, prolonged hospital stay, deep vein thrombosis with embolic events, increased psychological stress thereby increasing morbidity and mortality of TKR patients.Physiotherapy, principally exercise prescription and gait re- education, is advocated for people after THR and TKR.Surgeons are particularly concerned regarding cementless implants, given they rely on press fit fixation in the surrounding bone for primary stability.Patients undergoing total knee arthroplasty often have unfulfilled expectations from the surgery that can lead to dissatisfaction.Patients have a poor understanding of outcomes related to total knee replacement (TKR) surgery, with most patients underestimating the potential benefits and overestimating the risk of complications.To prevent chronic pain after TKR, several perioperative interventions show benefits and merit further research. Enhanced Recovery After Surgery (ERAS) has been successfully adopted across a range of procedures with using rehabilitation program. This study will focus on effects of structured rehabilitation program of 4 weeks with different goals in each week for reducing pain and improving function in patients with knee osteoarthritis. Study will provide a structured rehabilitation program for the physiotherapist to achieve all goals in three phases (protective, Recovery \& Activity phase).
AP Antony-Leo 2019 in this RCT study improvements occurred by following structured rehabilitation care,quality of life and joint specific outcomes through medial parapatellear approach.Andrew David Beswick. In TKR to prevent chronic pain, showing benefits by using several perioperative interventions.In this systematic review the patients with osteoarthritis achieve long term outcomes after TKR by using perioperative interventions. In evidence base review enhanced recovery after surgery had already been used successfully in various surgical specialities. This evidence-based review provides an insight into the best evidence linked to each component and their rationale for inclusion in the proposed enhanced recovery after surgery protocol. Arijit Goshi 2019. In this evidence base review enhanced recovery programmes require a multidisciplinary team of dedicated professionals, principally involving preoperative education, multimodal pain control and accelerated rehabilitation; this will be enhanced if combined with minimally invasive surgery. The current economic environment and restricted healthcare budget further necessitate brief hospitalisation while minimising costs.MS Ibrahim 2019.C.E.H Scott 2019. The patient satisfaction rate of 81.4 % at 12 month in this study is comparable to other studies.In this prospective study it is important to clear that whether dissatisfaction is a consequence of surgical technique, implant design, patient selection, or counselling and the management of expectation. This study provided knowledge about to help patient selection and counselling. Soren T.Sku 2019 in an RCT study in patients with knee osteoarthritis who were eligible for total knee replacement, treatment with total knee replacement followed by nonsurgical treatment resulted in greater pain relief and functional improvement after 12 month as compared to nonsurgical treatment.Literature shows that postoperative rehabilitation for total knee replacement is of prime importance and improves postoperative outcomes and it would be more beneficial to divide outcome goals in phases so as to achieve these goals according to week wise distribution
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Structured rehabilitation program | Experimental | Other: Structured Rehabilitation Program, Other: Conventional Physical TherapyStructured rehabilitation program \& conventional physical therapy |
| conventional physical therapy | Active comparator | Other: Conventional Physical Therapyconventional physical therapy |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient with unilateral or bilateral total knee replacement through medial parapatellar approach.
Key exclusion criteria (4 listed)
- Patients awaiting revision TKR
- Post traumatic patients planned for TKR
- Those with non-degenerative joint diseases
- Patients got infected after operation
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 |
|---|---|---|
| Structured Rehabilitation ProgramEarly Function Phase (Protective phase) week 1 Progressive Function Phase (Recovery Phase) 2nd and 3rd week Advance Function Phase (Activity Phase) 4th week | Other | Structured rehabilitation program |
| Conventional Physical Therapy• Rapid post-operative mobilization • Range of motion exercises started • Passive extension by placing pillow under foot • Flexion-by dangling the leg over the side of bed • Muscle strengthening exercises • Weight bearing is allowed on 1st post-operative | Other | Structured rehabilitation program, conventional physical therapy |
Primary outcome
Numeric Pain Rating Scale (NPRS)
Time frame: 4th week
NPRS is a segmented version of Visual Analogue Scale (VAS). It consists of number from 0 to 10. Patient selects a number that best reflects his/her pain intensity where 0 is no pain and 10 is maximum pain. For construct validity, NPRS was highly correlated to Visual Analogue Scale (VAS) (0.86-0.95). The test-retest reliability of this scale is recorded to be 0.96. (Hawker et al. 2011)
6 Minute walk test
Time frame: 4th week
The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6-minute walk distance (6 MWD) provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise. The 6 MWT provides information regarding functional capacity, response to therapy and prognosis across a broad range of chronic cardiopulmonary conditions. Main strengths of the 6 MWT stem from its simplicity in concept and performance, low cost, ease of standardization, and acceptance by test subjects, including those who are deconditioned, elderly, or frail.
WOMAC SCALE
Time frame: 4th week
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. The WOMAC measures five items for pain (score range 0- 20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68).[2] Physical functioning questions cover everyday activities such as stair use, standing up from a sitting or lying position, standing, bending, walking, getting in and out of a car, shopping, putting on or taking off socks, lying in bed, getting in or out of a bath, sitting, and heavy and light household duties.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.
- Background: PubMed 31467647Antony-Leo AP, Arun-Maiya G, Mohan-Kumar M, Vijayaraghavan PV. Structured Total Knee Replacement Rehabilitation Programme and Quality of Life following Two Different Surgical Approaches - A Randomised Controlled Trial. Malays Orthop J. 2019 Jul;13(2):20-27. doi: 10.5704/MOJ.1907.004.
- Background: PubMed 19464898Willis-Owen CA, Brust K, Alsop H, Miraldo M, Cobb JP. Unicondylar knee arthroplasty in the UK National Health Service: an analysis of candidacy, outcome and cost efficacy. Knee. 2009 Dec;16(6):473-8. doi: 10.1016/j.knee.2009.04.006. Epub 2009 May 22.
- Background: PubMed 10635429Nussenzveig TC. Pain management after total joint replacement and its impact on patient outcomes. AORN J. 1999 Dec;70(6):1060-2. doi: 10.1016/s0001-2092(06)62213-8. No abstract available.
- Background: PubMed 31977370Skrejborg P, Petersen KK, Beck J, Ulrich M, Simonsen O, Nielsen PT, Arendt-Nielsen L, Laursen M. Investigating the Effect of Perioperative Chlorzoxazone on Acute Postoperative Pain After Total Hip and Knee Replacement Surgery. Clin J Pain. 2020 May;36(5):352-358. doi: 10.1097/AJP.0000000000000805.
- Background: PubMed 32005197Mohammad HR, Kennedy JA, Mellon SJ, Judge A, Dodd CA, Murray DW. The clinical outcomes of cementless unicompartmental knee replacement in patients with reduced bone mineral density. J Orthop Surg Res. 2020 Jan 31;15(1):35. doi: 10.1186/s13018-020-1566-2.
- Background: PubMed 30298413Levinger P, Bartlett JR, Bergman NR, McMahon S, Menz HB, Hill KD. The discrepancy between patient expectations and actual outcome reduces at the first 6 months following total knee replacement surgery. Knee Surg Sports Traumatol Arthrosc. 2019 Jul;27(7):2042-2050. doi: 10.1007/s00167-018-5210-1. Epub 2018 Oct 8.
- Background: PubMed 29799668Fraenkel L, Benjamin Nowell W, Stake CE, Venkatachalam S, Eyler R, Michel G, Peters E. Impact of Information Presentation Format on Preference for Total Knee Replacement Surgery. Arthritis Care Res (Hoboken). 2019 Mar;71(3):379-384. doi: 10.1002/acr.23605.
- Background: PubMed 31494601Beswick AD, Dennis J, Gooberman-Hill R, Blom AW, Wylde V. Are perioperative interventions effective in preventing chronic pain after primary total knee replacement? A systematic review. BMJ Open. 2019 Sep 6;9(9):e028093. doi: 10.1136/bmjopen-2018-028093.
- Background: PubMed 29409177Wainwright TW, Immins T, Antonis JHA, Taylor H, Middleton RG. Can the introduction of Enhanced Recovery After Surgery (ERAS) reduce the variation in length of stay after total ankle replacement surgery? Foot Ankle Surg. 2019 Jun;25(3):294-297. doi: 10.1016/j.fas.2017.12.005. Epub 2017 Dec 21.
- Background: PubMed 30212288Ghosh A, Chatterji U. An evidence-based review of enhanced recovery after surgery in total knee replacement surgery. J Perioper Pract. 2019 Sep;29(9):281-290. doi: 10.1177/1750458918791121. Epub 2018 Sep 13. No abstract available.
- Background: PubMed 24025284Ibrahim MS, Alazzawi S, Nizam I, Haddad FS. An evidence-based review of enhanced recovery interventions in knee replacement surgery. Ann R Coll Surg Engl. 2013 Sep;95(6):386-9. doi: 10.1308/003588413X13629960046435.
- Background: PubMed 20798443Scott CE, Howie CR, MacDonald D, Biant LC. Predicting dissatisfaction following total knee replacement: a prospective study of 1217 patients. J Bone Joint Surg Br. 2010 Sep;92(9):1253-8. doi: 10.1302/0301-620X.92B9.24394.
- 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.
Saima Zahid, PhD* principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Rehabilitation Program and Conventional Physical Therapy in people with Knee, run by Riphah International University at 1 site in Pakistan.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 24 Aug 2021. 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 Pakistan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating Scale (NPRS) (time frame: 4th week). The study lists 3 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 NCT04694625, which also lists 15 linked publications.
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 24 Aug 2021.