The purpose of this study is to analyze stability, safety and efficacy of the Metaphyseal Hip Prosthesis (MHP) compared to the Stanmore hip replacement.
The purpose of this study is to analyze stability, safety and efficacy of the Metaphyseal Hip Prosthesis (MHP) compared to the Stanmore hip replacement at short term (1 year) and long term (10 years). Bone remodeling will be analyzed at 10 years using DEXA (Dual Energy X-Ray Absorptiometry (bone scan test)) measurements. This is a single-center prospective study with 25 patients in the study and 25 in the control group in open Randomized Clinical Trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Metaphyseal Hip Prosthesis (MHP) hip replacement
Stanmore hip prosthesis
Bravis Ziekenhuis Roosendaal
Roosendaal, Netherlands
RSA Translation X
Stem movement measured with RSA (radiostereometric analysis) along the x-axis in mm. RSA is a technique to accurately measure 3D movement of the prosthesis in the bone. The movement is measured with respect to the situation directly postoperative.
Time frame: 3 months, 6 months, 1 year and 2 years postoperatively
RSA Translation Y
Stem movement along the y-axis in mm. (measured with RSA)
Time frame: 3 months, 6 months, 1 year and 2 years postoperatively
RSA Translation Z
Stem movement along z-axis in mm (measured with RSA)
Time frame: 3 months, 6 months, 1 year and 2 years postoperatively
RSA Rotation X
Stem Rotation around X-axis in degrees (measured with RSA)
Time frame: 3 months, 6 months, 1 year and 2 years postoperatively
RSA Rotation Y
Stem rotation around the y-axis in degrees ( measured with RSA)
Time frame: 3 months, 6 months, 1 year and 2 years postoperatively
RSA Rotation Z
Stem rotation around the z-axis in degrees (measured with RSA)
Time frame: 3 months, 6 months, 1 year and 2 years postoperatively
RSA MTMP
Maximum Total Point Motion (MTPM) measured with RSA. This is a mean for the total migration of the stem.
Time frame: 3 months, 6 months, 1 year and 2 years postoperatively
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Number of Reported Device Related Complications
Safety: \- Frequency of serious device related complications.
Time frame: 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, 10 years postoperatively
Harris Hip Score
Harris Hip Score (HHS), a score to measure health and satisfaction after a hip prosthesis. The score has a maximum of 100 points (best possible outcome) covering pain (1 item, 0-44 points), function (7 items, 0-47 points), absence of deformity (1 item, 4 points), and range of motion (2 items, 5 points)
Time frame: pre-operatively, 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, and 10 years postoperatively
DEXA
Efficacy: Bone density measured using the average DEXA score in each zone. For the long Stanmore the 7 Gruen zones were defined. For the short MHP stem an adjusted model with only 5 zones was used. The scan at 6 weeks is used as the baseline measurement to analyze if the bone density changes in the following years. At 1 year and 2 year follow up, percentual change is presented for both groups with respect to the 6 weeks DEXA score
Time frame: 1 and 2 years postoperative
HOOS-Pain Subscale
HOOS (Hip disability and Osteoarthritis Outcome Score) consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and hip related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
Time frame: pre-operatively, 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, and 10 years postoperatively
HOOS-Symptom Subscale
HOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and hip related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
Time frame: pre-operatively, 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, and 10 years postoperatively
HOOS-ADL Subscale
HOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and hip related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
Time frame: pre-operatively, 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, and 10 years postoperatively
HOOS-Sport Subscale
HOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and hip related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
Time frame: pre-operatively, 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, and 10 years postoperatively
HOOS-QoL Subscale
HOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and hip related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
Time frame: pre-operatively, 6 weeks, 3 months, 6 months, 1,2, 3, 4, 5, 6, 7, and 10 years postoperatively
SF-12 Physical Summary Score
12-Item Short-Form Health Survey (SF-12) presented in Physical (PS) and Mental summary (MS) scores (range 0-100). A zero score indicates the lowest level of health and 100 indicates the highest level of health.
Time frame: pre-operatively, 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, and 10 years postoperatively
SF-12 Mental Summary Score
SF-12 Score presented in Physical and Mental summary scores (range 0-100). A zero score indicates the lowest level of health and 100 indicates the highest level of health.
Time frame: pre-operatively, 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, and 10 years postoperatively