CClinicalTrials.gg
CompletedNCT04694625Updated Aug 24, 2021

Structured Rehabilitation Program for Patients With Total Knee Replacement

An interventional study of Structured Rehabilitation Program and Conventional Physical Therapy in Knee, sponsored by Riphah International University. Completed at 1 site in Pakistan. Open to participants aged 50 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-08-24.

Sponsored by Riphah International University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
50 Years to 65 Years
Sex
All
01

Study 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. 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

02

Conditions studied

  • Knee

Keywords

  • Knee pain
  • knee Replacement
  • Degenerative knee disease
03

In context

Lead sponsor

Riphah International University is the lead sponsor of 2,133 studies on the registry; 633 are open to participants now.

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

04

Who can participate

Ages eligible
50 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patient with unilateral or bilateral total knee replacement through medial parapatellar approach.

Exclusion criteria

Exclusion Criteria:

  • Patients awaiting revision TKR
  • Post traumatic patients planned for TKR
  • Those with non-degenerative joint diseases
  • Patients got infected after operation
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
26 participants (actual)

Study arms

  • Experimental
    Structured rehabilitation program

    Structured rehabilitation program \& conventional physical therapy

    Other: Structured Rehabilitation Program · Other: Conventional Physical Therapy

  • Active comparator
    conventional physical therapy

    conventional physical therapy

    Other: Conventional Physical Therapy

Interventions

  • OtherStructured Rehabilitation Program

    Early Function Phase (Protective phase) week 1 Progressive Function Phase (Recovery Phase) 2nd and 3rd week Advance Function Phase (Activity Phase) 4th week

  • OtherConventional 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

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 4th week

  2. 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.

    Time frame: 4th week

  3. 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.

    Time frame: 4th week

07

Study locations

1 site
  • Horizon Hospital Lahore
    Lahore, Punjab, Pakistan
08

References and documents

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 31467647 ↗
  • Willis-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 19464898 ↗
  • Nussenzveig 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 10635429 ↗
  • Skrejborg 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 31977370 ↗
  • Mohammad 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 32005197 ↗
  • Levinger 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 30298413 ↗
  • Fraenkel 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 29799668 ↗
  • Beswick 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 31494601 ↗
  • Wainwright 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 29409177 ↗
  • Ghosh 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 30212288 ↗
  • Ibrahim 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 24025284 ↗
  • Scott 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 20798443 ↗
  • Skou 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 26488691 ↗
  • Bade 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 27813347 ↗
  • Barker 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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 24, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04694625
Lead sponsor
Riphah International University
Responsible party
Sponsor
First posted
Jan 5, 2021
Start date
Jan 10, 2021
Primary completion
Jul 10, 2021
Completion
Jul 20, 2021
Last update
Aug 24, 2021

Study contacts

Saima Zahid, PhD*
principal investigator · Riphah International University

Oversight

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

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