NCT00266396

Brief Summary

Despite the widespread use of total hip and knee arthroplasty, there is a notable lack of consensus regarding postoperative treatment, mostly because of the lack of well-designed studies testing the efficacy and effectiveness of such practices. In particular, there are no evidence-based recommendations on the amount of weight that the patient should be advised to bear on the operated leg after the operation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
352

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2002

Longer than P75 for phase_1

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

December 15, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 16, 2005

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

April 6, 2016

Status Verified

April 1, 2016

Enrollment Period

5 years

First QC Date

December 15, 2005

Last Update Submit

April 4, 2016

Conditions

Osteoarthritis

Keywords

Total Hip ArthroplastyTHATotal Knee ArthroplastyTKATotal Hip ReplacementTHRTotal Knee ReplacementTKR

Outcome Measures

Primary Outcomes (1)

  • Physical function, measured by means of the Western Ontario and McMaster universities (WOMAC) osteoarthritis index

    Baseline, 3, 6, 12 and 24-months after surgery

Secondary Outcomes (5)

  • Leg specific stiffness and pain, both measured by the WOMAC.

    Baseline, 3, 6, 12 and 24-months after surgery

  • Physical component summary of the SF-36

    Baseline, 3, 6, 12 and 24-months after surgery

  • Lequesne Hip resp. Knee Score

    Baseline, 3, 6, 12 and 24-months after surgery

  • Patient satisfaction

    Baseline, 3, 6, 12 and 24-months after surgery

  • Quality-Adjusted Life Years

    Baseline, 3, 6, 12 and 24-months after surgery

Study Arms (1)

weight-bearing recommendation

EXPERIMENTAL

Weight-bearing recommendation after THA and TKA

Behavioral: Recommend full weight-bearingBehavioral: Recommend parital weight-bearing

Interventions

Recommend full weight-bearingBEHAVIORAL

The full weight-bearing group is trained in 4-point gait with crutches and is recommended to put as much weight as tolerated on the leg on which surgery has been performed, immediately after surgery

weight-bearing recommendation
Recommend parital weight-bearingBEHAVIORAL

The partial weight-bearing group is trained in 3-point gait with crutches and is instructed to limit weight-bearing of the affected leg to 20kg for a period of six-weeks. Scales are used to train these participants not to exceed 20kg

weight-bearing recommendation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patient who is about to receive unilateral hip or knee replacement surgery on an elective basis for diagnosis of osteoarthritis or femoral head necrosis

You may not qualify if:

  • A history of septic arthritis,
  • Hip fracture,
  • Intraoperative complications,
  • History of implant surgery on the joint to be operated on,
  • Rheumatoid arthritis,
  • Amputations,
  • Inability to complete the questionnaires because of cognitive or language difficulties.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Ostseeklinik Damp, Department I of Orthopedic Surgery

Damp, 24351, Germany

Location

University of Schleswig-Holstein Medical Center, Kiel Campus

Kiel, 24105, Germany

Location

University of Schleswig-Holstein Medical Center, Lübeck Campus

Lübeck, 23538, Germany

Location

Wedel Hospital, Department of Surgery

Wedel, 22880, Germany

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Thoralf R Liebs, MD

    University of Schleswig-Holstein Medical Center, Kiel Campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Orthopaedic Surgeon

Study Record Dates

First Submitted

December 15, 2005

First Posted

December 16, 2005

Study Start

January 1, 2002

Primary Completion

January 1, 2007

Study Completion

January 1, 2007

Last Updated

April 6, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share

Locations

DE(4)