Immediate Post-THA Functional Assessment

Arthritis of Hip Clinical Trial

Official title:

Functional Biomechanical Analysis in Immediate Post-Operative Period Following Total Hip Arthroplasty - A Pilot Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04928924
• Other study ID #: 19-07
• Status: Enrolling by invitation
• Start date: April 26, 2021
• Est. completion date: April 2022

Study information

• Verified date: June 2021
• Source: Golden Jubilee National Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The objective of this study is to investigate the feasibility of functional 3D biomechanical assessment and EMG analysis of gait and a sit to stand tasks in the immediate post-operative phase following total hip arthroplasty.

Description:

Functional recovery is often an important priority for patients undergoing total hip arthroplasty (THA) and it is thought that abnormal biomechanics may be an obstacle to full recovery of physical function. While there has been extensive research on the biomechanics of gait and other activities of daily living following THA, the earliest reported post-operative assessment of function using 3D motion analysis for kinematics and kinetics has been at 6 weeks post-surgery. There is a paucity of data from the immediate post-operative phase prior to patient discharge from hospital.

In recent years there has been an increase in initiatives such as fast-track or enhanced post-operative recovery programs following joint arthroplasty, with the aim being an early return to function and shorter hospital length of stay whilst maintaining the low morbidity and mortality and high satisfaction rates typically associated with THA. There has also been continued research and developments on improving the THA procedure and while initial focus on improving THA surgery centred on implant design, materials and fixation to bone, there has been increased attention to surgical approach. In the last 10 years the use of minimally invasive surgical techniques has become more widespread due to the potential reported benefits. These include a shorter incision length, reduced muscle damage, reduced pain and less bleeding. When combined, these benefits may lead to reduced length of hospital stay and earlier return to function.

With so much focus centred on early return to function, there is a need to objectively measure function in the immediate post-operative phase. This would allow us to evaluate the effect of minimally invasive surgical approaches and enhanced recovery programs, which are primarily centred on early recovery from surgery. The use of 3D motion capture technology allows for accurate assessment of joint movement in three planes during dynamic movements and has been used extensively in the evaluation of function in patients with significant hip pathology before and after total hip arthroplasty. As aforementioned, to date the earliest post-operative motion analysis has been at 6 weeks after THA. Similarly, the earliest reported time point for muscle activation analysis using EMG is 6 weeks post THA. The aim of this study is assess the feasibility of 3D motion analysis including EMG in the immediate post-operative phase following THA in a hospital which incorporates an Enhanced Recovery After Surgery (ERAS) program as part of routine clinical care. This pilot project will guide development of future protocols which require early post-operative 3D biomechanical analysis.

For the purposes of this study the investigators define the immediate post-operative time point as the day the patient is discharged from the inpatient rehabilitation team and therefore deemed "safe" to mobilise independently by the ward physiotherapists.

Subject recruitment and retention will be closely monitored throughout the trial, allowing us to measure recruitment and dropout rates. Where possible, reasons for declining participation in the study and reasons for dropout will be documented. The ability of the patients to perform study related assessments will be recorded in addition to the reason for them being unable to perform the task, this will be done via a questionnaire that patients will complete at the end of each 3D biomechanical assessment session.

Patients will be asked to attend a biomechanical testing session before their surgery. After surgery they will follow standard aftercare, and on the day of discharge from the inpatient physiotherapy team they will be asked to attend the second biomechanical testing session. The third and fourth sessions will be on day three and day seven post-surgery, and the final session will take place when they return to the hospital for their standard three month follow up with the arthroplasty team. At the end of the three month visit, their involvement in the study will be complete.

Biomechanical movement analysis will be carried out in an on-site movement analysis laboratory. Study participants will be required to wear suitable clothing (e.g. tee shirt and shorts) and be barefoot. A number of reflective markers and surface electrodes will be attached to specific locations on the body using suitable double sided tape which can be tracked by a number of infrared cameras. participants will be asked to perform the following tasks; walking, sit-to-stand and stand-to-sit. Each task will be performed at least three times to enable the collection of three good sets of data. A motion capture system will collect limb and torso movements during the task performances while force plates will collect ground reaction forces.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 10
• Est. completion date: April 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients suitable for posterolateral approach total hip arthroplasty

• Able to give informed consentAble to return to study site for follow-up

• BMI under 35

Exclusion Criteria:

• Previous hip procedure in the previous twelve months

• Previous knee surgery other than arthroscopy and medial menisectomy in the last twelve months

• Symptomatic foot, knee, contralateral hip or spinal pathology

• Any medical condition limiting normal ambulation e.g. stroke, Parkinsons disease, severe lymphedema, advanced cardiac disease

• Unable to read and understand English and follow verbal and visual instructions unless they can bring a relative or friend to all study assessments to act as a translator

Related Conditions & MeSH terms

• Arthritis
• Arthritis of Hip

Intervention

Procedure:
• Total Hip Arthroplasty
We will be observing patients who have undergone surgical replacement of arthritic hip with an implant.

Locations

Country	Name	City	State
United Kingdom	Golden Jubilee National Hospital	Clydebank

Sponsors (2)

Lead Sponsor	Collaborator
Golden Jubilee National Hospital	Stryker GI Ltd.

Country where clinical trial is conducted

United Kingdom, 

References & Publications (19)

Agostini V, Ganio D, Facchin K, Cane L, Moreira Carneiro S, Knaflitz M. Gait parameters and muscle activation patterns at 3, 6 and 12 months after total hip arthroplasty. J Arthroplasty. 2014 Jun;29(6):1265-72. doi: 10.1016/j.arth.2013.12.018. Epub 2013 Dec 18. — View Citation

Bahl JS, Nelson MJ, Taylor M, Solomon LB, Arnold JB, Thewlis D. Biomechanical changes and recovery of gait function after total hip arthroplasty for osteoarthritis: a systematic review and meta-analysis. Osteoarthritis Cartilage. 2018 Jul;26(7):847-863. doi: 10.1016/j.joca.2018.02.897. Epub 2018 Feb 21. — View Citation

Beaulieu ML, Lamontagne M, Beaulé PE. Lower limb biomechanics during gait do not return to normal following total hip arthroplasty. Gait Posture. 2010 Jun;32(2):269-73. doi: 10.1016/j.gaitpost.2010.05.007. Epub 2010 Jun 11. — View Citation

Bennett D, Ryan P, O'Brien S, Beverland DE. Gait kinetics of total hip replacement patients-A large scale, long-term follow-up study. Gait Posture. 2017 Mar;53:173-178. doi: 10.1016/j.gaitpost.2017.01.014. Epub 2017 Jan 21. — View Citation

Bernard J, Razanabola F, Beldame J, Van Driessche S, Brunel H, Poirier T, Matsoukis J, Billuart F. Electromyographic study of hip muscles involved in total hip arthroplasty: Surprising results using the direct anterior minimally invasive approach. Orthop Traumatol Surg Res. 2018 Dec;104(8):1137-1142. doi: 10.1016/j.otsr.2018.03.013. Epub 2018 May 16. — View Citation

Dorr LD, Maheshwari AV, Long WT, Wan Z, Sirianni LE. Early pain relief and function after posterior minimally invasive and conventional total hip arthroplasty. A prospective, randomized, blinded study. J Bone Joint Surg Am. 2007 Jun;89(6):1153-60. — View Citation

Ewen AM, Stewart S, St Clair Gibson A, Kashyap SN, Caplan N. Post-operative gait analysis in total hip replacement patients-a review of current literature and meta-analysis. Gait Posture. 2012 May;36(1):1-6. doi: 10.1016/j.gaitpost.2011.12.024. Epub 2012 Mar 10. Review. — View Citation

Hermens HJ, Freriks B, Disselhorst-Klug C, Rau G. Development of recommendations for SEMG sensors and sensor placement procedures. J Electromyogr Kinesiol. 2000 Oct;10(5):361-74. — View Citation

Hossain M, Parfitt DJ, Beard DJ, Darrah C, Nolan J, Murray DW, Andrew G. Does pre-operative psychological distress affect patient satisfaction after primary total hip arthroplasty? BMC Musculoskelet Disord. 2011 Jun 1;12:122. doi: 10.1186/1471-2474-12-122. — View Citation

Kolk S, Minten MJ, van Bon GE, Rijnen WH, Geurts AC, Verdonschot N, Weerdesteyn V. Gait and gait-related activities of daily living after total hip arthroplasty: a systematic review. Clin Biomech (Bristol, Avon). 2014 Jun;29(6):705-18. doi: 10.1016/j.clinbiomech.2014.05.008. Epub 2014 Jun 2. Review. — View Citation

Lamontagne M, Beaulieu ML, Varin D, Beaulé PE. Lower-limb joint mechanics after total hip arthroplasty during sitting and standing tasks. J Orthop Res. 2012 Oct;30(10):1611-7. doi: 10.1002/jor.22127. Epub 2012 Apr 16. — View Citation

Longworth JA, Chlosta S, Foucher KC. Inter-joint coordination of kinematics and kinetics before and after total hip arthroplasty compared to asymptomatic subjects. J Biomech. 2018 Apr 27;72:180-186. doi: 10.1016/j.jbiomech.2018.03.015. Epub 2018 Mar 16. — View Citation

Lübbeke A, Katz JN, Perneger TV, Hoffmeyer P. Primary and revision hip arthroplasty: 5-year outcomes and influence of age and comorbidity. J Rheumatol. 2007 Feb;34(2):394-400. Epub 2006 Nov 15. — View Citation

Mariconda M, Galasso O, Costa GG, Recano P, Cerbasi S. Quality of life and functionality after total hip arthroplasty: a long-term follow-up study. BMC Musculoskelet Disord. 2011 Oct 6;12:222. doi: 10.1186/1471-2474-12-222. — View Citation

Mayr E, Nogler M, Benedetti MG, Kessler O, Reinthaler A, Krismer M, Leardini A. A prospective randomized assessment of earlier functional recovery in THA patients treated by minimally invasive direct anterior approach: a gait analysis study. Clin Biomech (Bristol, Avon). 2009 Dec;24(10):812-8. doi: 10.1016/j.clinbiomech.2009.07.010. Epub 2009 Aug 21. — View Citation

Nilsdotter AK, Isaksson F. Patient relevant outcome 7 years after total hip replacement for OA - a prospective study. BMC Musculoskelet Disord. 2010 Mar 11;11:47. doi: 10.1186/1471-2474-11-47. — View Citation

Pabinger C, Lothaller H, Portner N, Geissler A. Projections of hip arthroplasty in OECD countries up to 2050. Hip Int. 2018 Sep;28(5):498-506. doi: 10.1177/1120700018757940. Epub 2018 May 21. — View Citation

Palan J, Manktelow A. Surgical approaches for primary total hip replacement. Orthopaedics and Trauma. 2018;32(1):1-12.

Stief F, Schmidt A, van Drongelen S, Lenarz K, Froemel D, Tarhan T, Lutz F, Meurer A. Abnormal loading of the hip and knee joints in unilateral hip osteoarthritis persists two years after total hip replacement. J Orthop Res. 2018 Mar 14. doi: 10.1002/jor.23886. [Epub ahead of print] — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient adherence to study procedures	Patients ability to attend for follow up appointments and carry out study specific biomechanical assessments	3 months
Secondary	Eligible patients	Number of suitable patients per consultant per month	1 year
Secondary	Recruitment rate	Percentage of eligible patients recruited	1 year
Secondary	Loss to follow up	Number of patients who choose to withdraw/ are lost to follow up	3 months
Secondary	Hip angles during walking	Hip angles of movement collected using clinical movement analysis	3 months
Secondary	Hip loads during walking	Hip loading collected using clinical movement analysis	3 months
Secondary	Hip angles during sit to stand to sit	Hip angles of movement collected using clinical movement analysis	3 months
Secondary	Hip loads during sit to stand to sit	Hip loading collected using clinical movement analysis	3 months
Secondary	Muscle activation patterns walking	Hip muscle activation during level walking	3 months
Secondary	Muscle activation patterns stand to sit to stand	Hip muscle activation during stand to sit to stand	3 months