Unrestricted Rehabilitation Following Primary THA

NCT02079467 | Unknown

• 1 other identifier: Miller-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether the form of rehabilitation following primary total hip arthroplasty has an influence on patient satisfaction or functional performance in the eighteen weeks following surgery.

Conditions

Osteoarthritis, Hip

Keywords

Arthroplasty, Hip; Replacement, Hip; Postoperative Care; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Timed Up and Go (TUG)

  The test involves measuring the duration of time required for a patient to rise from a standard arm chair, walk 3 metres, turn, walk back to the chair, and sit down.

  Six weeks post-operatively

Secondary Outcomes (16)

• 4-Item Pain Intensity Measure (P4)

  Baseline

• Lower extremity functional scale (LEFS)

  Baseline

• PROMIS Bank v2.0 - Satisfaction with Social Roles and Activities - Computerized Adaptive Testing

  Baseline

• Timed Up and Go (TUG)

  Baseline

• Timed Up and Go (TUG)

  Date of discharge following surgery (2 to 6 days post-op, but could be up to 2 weeks)

Study Arms (2)

Standard rehabilitation

ACTIVE COMPARATOR

Patients randomized to the control group will be managed with "hip precautions" immediately following surgery. They will weight bear on the operative joint as tolerated after surgery. They will be managed as per usual protocol post total hip arthroplasty. They will be transferred from the operative table with an abduction pillow between their legs and will be asked to keep this pillow between their legs while resting in bed and during sleep throughout their course in hospital. During physiotherapy treatments they will not flex the operative hip beyond 90 degrees, internally or externally rotate the operative hip more than 45 degrees, or actively adduct the operative hip past neutral.

Procedure: Standard rehabilitation

Unrestricted rehabilitation

EXPERIMENTAL

Patients randomized to the treatment group will have no restrictions in their post-operative rehabilitation. They will weight bear on the operative joint as tolerated after surgery. They will be asked to participate in activity as their level of comfort permits and will have no positional restrictions while in bed or completing activities of daily living.

Procedure: Unrestricted rehabilitation

Interventions

Unrestricted rehabilitation PROCEDURE

Standard care range of motion restrictions will not be used

Unrestricted rehabilitation

Standard rehabilitation PROCEDURE

Standard care range of motion restrictions will remain in place

Standard rehabilitation

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than 50 years
• Undergoing primary total hip arthroplasty at Holland Orthopaedic and Arthritic Centre

You may not qualify if:

• Any previous surgery about the ipsilateral hip
• Patients being considered for simultaneous bilateral total hip arthroplasty
• Patients with a neuromuscular disorder or recognized hypermobility syndrome
• Patients without sufficient language skills to communicate in spoken and written English

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Holland Orthopaedic and Arthritic Centre

Toronto, Ontario, M4Y 1H1, Canada

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

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

Study Officials

• Hans J Kreder, MD MPH FRCSC

  Sunnybrook Health Sciences Centre, University of Toronto

  PRINCIPAL INVESTIGATOR

• Richard Jenkinson, MD MSC FRCSC

  Sunnybrook Health Sciences Centre, University of Toronto

  PRINCIPAL INVESTIGATOR

• Veronica MR Wadey, BPHE BEd MD MA FRCSC

  Sunnybrook Health Sciences Centre, University of Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark W Miller, MD

CONTACT

416-381-0957; mark.miller@sunnybrook.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff surgeon

Study Record Dates

• First Submitted: December 4, 2013
• First Posted: March 5, 2014
• Study Start: December 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: November 1, 2014
• Last Updated: March 5, 2014

Record last verified: 2014-03

Locations

CA (1)