Use of the Orthoglide for Improved Patient Outcome Following Total Knee Replacement

NCT04418687 | Completed

• 1 other identifier: IRAS 235931
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

Total knee replacements are a common orthopaedic procedure undertaken at Blackpool Victoria Hospital. Following surgery patients are routinely seen by Physiotherapists who prescribe exercises to improve the range of movement and strength of the knee joint, thus aiding recovery. One of the key exercises prescribed involves the bending and straightening of the knee to improve range of movement. At this early stage of rehabilitation , due to weakness in the knee joint, reducing any resistance to this motion is beneficial. The Orthoglide device is designed to aid the patient in performing this movement by reducing the friction/resistance caused by the heel sliding against the bed. Currently this is achieved using a 'slider board' and placing a rolled up piece of fabric under the patients heel. The aim of this study is to investigate whether or not issuing an Orthoglide device to patients following total knee replacements improves functional outcomes reported by the patient at 6 weeks and 12 weeks post-surgery. Participants will be assigned to either receive an Orthoglide device and standard Physiotherapy or standard Physiotherapy alone. A series of patient reported outcome measures will be taken pre-surgery, 6 weeks post surgery and 12 weeks post surgery and the results compared.

Conditions

Knee Osteoarthritis; Physiotherapy; Intervention; Rehabilitation; Exercise

Keywords

Knee Osteoarthritis; Orthoglide; Knee exercises; KOOS; rehabilitation

Outcome Measures

Primary Outcomes (1)

• Change in Knee Osteoarthritis Outcome Score (KOOS)

  Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms. A better score would be indicated by a higher number closer to 100.

  Change from Baseline to 6 and 12 weeks

Secondary Outcomes (2)

• Change in Numerical Pain Rating Score (NPRS)

  Change from Baseline to 6 and 12 weeks

• Change in Exercise Adherence Rating Scale

  Change from Baseline to 6 and 12 weeks

Study Arms (2)

Physiotherapy only

ACTIVE COMPARATOR

Standard treatment post Total Knee Arthroplasty

Other: Physiotherapy only

Physiotherapy + Orthoglide intervention

EXPERIMENTAL

Standard treatment post TKA, with additional Orthoglide device provided.

Device: Orthoglide

Interventions

Orthoglide DEVICE

Knee rehabilitation device.

Physiotherapy + Orthoglide intervention

Physiotherapy only OTHER

Physiotherapy only.

Also known as: Physiotherapy

Physiotherapy only

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients planned to undergo a unilateral total knee replacement at Blackpool Victoria Hospital aged between 45 to 75 years,
• Independently mobile with or without a walking aid.

You may not qualify if:

• Other lower limb orthopaedic surgery within the last six-months,
• No anticipated further lower limb orthopaedic surgery within the next 12-months,
• No rheumatoid arthritis, neurological conditions affecting lower limb function.
• No Cognitive impairment,
• No co-morbidity which would act as a contraindication to engaging with prescribed exercise
• No existing participation in other clinical trials which may impact rehabilitation outcomes.

Sponsors & Collaborators

• Ambreen Chohan: lead
• Blackpool Victoria Hospital: collaborator

Study Sites (1)

Blackpool Victoria Hospital

Blackpool, Lancashire, FY3 8NR, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Motor Activity

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• James Richards, PhD

  University of Central Lancashire

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the nature of the study it was not possible to blind the participant to the treatment being received.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Fellow, Sponsor-Investigator

Model Details: Group 1: Physiotherapy with Orthoglide Group 2: Physiotherapy only

Study Record Dates

• First Submitted: March 15, 2020
• First Posted: June 5, 2020
• Study Start: November 28, 2018
• Primary Completion: February 15, 2020
• Study Completion: March 31, 2020
• Last Updated: June 5, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)